[Federal Register Volume 77, Number 29 (Monday, February 13, 2012)]
[Proposed Rules]
[Pages 7946-7959]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-1647]
[[Page 7945]]
Vol. 77
Monday,
No. 29
February 13, 2012
Part VIII
Department of Health and Human Services
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Semiannual Regulatory Agenda
Federal Register / Vol. 77 , No. 29 / Monday, February 13, 2012 /
Unified Agenda
[[Page 7946]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
21 CFR Ch. I
42 CFR Chs. I-V
45 CFR Subtitle A; Subtitle B, Chs. II, III, and XIII
Regulatory Agenda
AGENCY: Office of the Secretary, HHS.
ACTION: Semiannual regulatory agenda.
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SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order
(EO) 12866 require the semiannual issuance of an inventory of
rulemaking actions under development throughout the Department with a
view to offering summarized information about forthcoming regulatory
actions for public review.
FOR FURTHER INFORMATION CONTACT: Jennifer M. Cannistra, Executive
Secretary, Department of Health and Human Services, Washington, DC
20201.
SUPPLEMENTARY INFORMATION: The information provided in the Agenda
presents a forecast of the rulemaking activities that the Department of
Health and Human Services (HHS) expects to undertake in the foreseeable
future.
Rulemakings are grouped according to pre-rulemaking actions,
proposed rules, final rules, long-term actions, and rulemaking actions
completed since the spring 2011 Agenda was published.
Please note that the rulemaking abstracts included in this paper
issue of the Federal Register relate strictly to those prospective
rulemakings that are likely to have a significant economic impact on a
substantial number of small entities, as required by the Regulatory
Flexibility Act of 1980. Also available in this issue of the Federal
Register is the Department's submission to the Fiscal Year 2011
Regulatory Plan, required under Executive Order 12866.
The complete Regulatory Agenda of the Department is accessible
online at www.reginfo.gov in an interactive format that offers users
enhanced capabilities to obtain information from the Agenda's database.
The purpose of the Agenda is to encourage more effective public
participation in the regulatory process.
Jennifer M. Cannistra,
Executive Secretary to the Department.
Substance Abuse and Mental Health Services Administration--Final Rule
Stage
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Regulation
Sequence No. Title Identifier No.
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321....................... Opioid Drugs in 0930-AA14
Maintenance or
Detoxification Treatment
of Opiate Addiction
(Section 610 Review).
------------------------------------------------------------------------
Centers for Disease Control and Prevention--Proposed Rule Stage
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Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
322....................... Establishment of Minimum 0920-AA46
Standards for Birth
Certificates.
------------------------------------------------------------------------
Centers for Disease Control and Prevention--Long-Term Actions
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Regulation
Sequence No. Title Identifier No.
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323....................... Control of Communicable 0920-AA12
Diseases: Foreign.
324....................... Control of Communicable 0920-AA22
Diseases: Interstate.
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Food and Drug Administration--Prerule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
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325....................... Over-the-Counter (OTC) 0910-AF43
Drug Review--Sunscreen
Products.
326....................... Prescription Drug 0910-AG14
Marketing Act of 1987;
Prescription Drug
Amendments of 1992;
Policies, Requirements,
and Administrative
Procedures (Section 610
Review).
327....................... Requirements for Testing 0910-AG61
Human Blood Donors for
Evidence of Infection Due
to Communicable Disease
Agents (Section 610
Review).
328....................... General Requirements for 0910-AG62
Blood, Blood Components,
and Blood Derivatives;
Donor Notification
(Section 610 Review).
------------------------------------------------------------------------
Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
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329....................... Electronic Submission of 0910-AC52
Data From Studies
Evaluating Human Drugs
and Biologics (Reg Plan
Seq No. 33).
330....................... Over-the-Counter (OTC) 0910-AF36
Drug Review-Internal
Analgesic Products.
331....................... Over-the-Counter (OTC) 0910-AF69
Drug Review-Topical
Antimicrobial Drug
Products.
332....................... Import Tolerances for 0910-AF78
Residues of Unapproved
New Animal Drugs in Food.
333....................... Laser Products; Amendment 0910-AF87
to Performance Standard.
[[Page 7947]]
334....................... Current Good Manufacturing 0910-AG10
Practice and Hazard
Analysis and Risk-Benefit
Preventive Controls for
Food for Animals (Reg
Plan Seq No. 34).
335....................... Over-the-Counter (OTC) 0910-AG12
Drug Review-Pediatric
Dosing for Cough/Cold
Products.
336....................... Electronic Distribution of 0910-AG18
Content of Labeling for
Human Prescription Drug
and Biological Products.
337....................... Amendment to the Current 0910-AG20
Good Manufacturing
Practice Regulations for
Finished Pharmaceuticals--
Second Phase.
338....................... Unique Device 0910-AG31
Identification (Reg Plan
Seq No. 35).
339....................... Produce Safety Regulation 0910-AG35
(Reg Plan Seq No. 36).
340....................... Hazard Analysis and Risk- 0910-AG36
Based Preventive Controls
(Reg Plan Seq No. 37).
341....................... ``Tobacco Products'' 0910-AG38
Subject to the Federal
Food, Drug, and Cosmetic
Act, as Amended by the
Family Smoking Prevention
and Tobacco Control Act.
342....................... Human Subject Protection; 0910-AG48
Acceptance of Data From
Clinical Studies for
Medical Devices.
343....................... General Hospital and 0910-AG54
Personal Use Devices:
Issuance of Draft Special
Controls Guidance for
Infusion Pumps.
344....................... Requirements for the 0910-AG59
Testing and Reporting of
Tobacco Product
Constituents,
Ingredients, and
Additives.
345....................... Amendments to the Current 0910-AG70
Good Manufacturing
Practice Regulations for
Finished Pharmaceuticals--
Components.
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References in boldface appear in The Regulatory Plan in part II of this
issue of the Federal Register.
Food and Drug Administration--Final Rule Stage
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Regulation
Sequence No. Title Identifier No.
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346....................... Infant Formula: Current 0910-AF27
Good Manufacturing
Practices; Quality
Control Procedures;
Notification
Requirements; Records and
Reports; and Quality
Factors (Reg Plan Seq No.
40).
347....................... Label Requirement for Food 0910-AF61
That Has Been Refused
Admission Into the United
States.
348....................... Food Labeling: Nutrition 0910-AG56
Labeling for Food Sold in
Vending Machines (Reg
Plan Seq No. 43).
349....................... Food Labeling: Nutrition 0910-AG57
Labeling of Standard Menu
Items in Restaurants and
Similar Retail Food
Establishments (Reg Plan
Seq No. 44).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
issue of the Federal Register.
Food and Drug Administration--Long-Term Actions
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Regulation
Sequence No. Title Identifier No.
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350....................... Food Labeling; Revision of 0910-AF22
the Nutrition and
Supplement Facts Labels.
351....................... Over-the-Counter (OTC) 0910-AF40
Drug Review-Oral Health
Care Products.
352....................... Pet Food Labeling 0910-AG09
Requirements.
353....................... Further Amendments to 0910-AG60
General Regulations of
the Food and Drug
Administration to
Incorporate Tobacco
Products.
354....................... Food Labeling: Hard 0910-AG82
Candies and Breath Mints.
355....................... Food Labeling; Serving 0910-AG83
Sizes; Reference Amounts
for Candies.
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Food and Drug Administration--Completed Actions
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Regulation
Sequence No. Title Identifier No.
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356....................... Over-the-Counter (OTC) 0910-AF32
Drug Review--Cough/Cold
(Bronchodilator) Products.
357....................... Over-the-Counter (OTC) 0910-AF68
Drug Review--Poison
Treatment Drug Products.
358....................... Cigarette Warning Label 0910-AG41
Statements.
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Centers for Medicare & Medicaid Services--Proposed Rule Stage
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Regulation
Sequence No. Title Identifier No.
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359....................... Covered Outpatient Drugs 0938-AQ41
(CMS-2345-P) (Section 610
Review).
360....................... Medicare and Medicaid 0938-AQ84
Electronic Health Record
Incentive Program--Stage
2 (CMS-0044-P).
361....................... Medicare and Medicaid 0938-AQ89
Programs: Reform of
Hospital and Critical
Access Hospital
Conditions of
Participation (CMS-3244-
P) (Reg Plan Seq No. 45).
362....................... Proposed Changes to 0938-AR10
Hospital OPPS and CY 2013
Payment Rates; ASC
Payment System and CY
2013 Payment Rates (CMS-
1589-P) (Section 610
Review) (Reg Plan Seq No.
47).
363....................... Revisions to Payment 0938-AR11
Policies Under the
Physician Fee Schedule
and Part B for CY 2013
(CMS-1590-P) (Section 610
Review) (Reg Plan Seq No.
48).
[[Page 7948]]
364....................... Changes to the Hospital 0938-AR12
Inpatient and Long-Term
Care Prospective Payment
System for FY 2013 (CMS-
1588-P) (Section 610
Review) (Reg Plan Seq No.
49).
365....................... Transparency Reports and 0938-AR33
Reporting of Physician
Ownership of Investment
Interests (CMS-5060-F).
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References in boldface appear in The Regulatory Plan in part II of this
issue of the Federal Register.
Centers for Medicare & Medicaid Services--Completed Actions
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Regulation
Sequence No. Title Identifier No.
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366....................... Proposed Changes to the 0938-AQ24
Hospital Inpatient
Prospective Payment
Systems for Acute Care
Hospitals and FY 2012
Rates and to the Long-
Term Care Hospital PPS
and FY 2012 Rates (CMS-
1518-F) (Completion of a
Section 610 Review).
367....................... Revisions to Payment 0938-AQ25
Policies Under the
Physician Fee Schedule
and Part B for CY 2012
(CMS-1524-FC) (Completion
of a Section 610 Review).
368....................... Changes to the Hospital 0938-AQ26
Outpatient Prospective
Payment System and
Ambulatory Surgical
Center Payment System for
CY 2012 (CMS-1525-F)
(Completion of a Section
610 Review).
369....................... Prospective Payment System 0938-AQ29
and Consolidated Billing
for Skilled Nursing
Facilities for FY 2012;
Required Disclosures of
Ownership (CMS-1351-F)
(Completion of a Section
610 Review).
370....................... Home Health Prospective 0938-AQ30
Payment System
Refinements and Rate
Update for CY 2012 (CMS-
1353-F) (Section 610
Review).
371....................... Enhanced Federal Funding 0938-AQ53
for Medicaid Eligibility
Determination and
Enrollment Activities
(CMS-2346-F).
372....................... Five Year Review of Work 0938-AQ87
Relative Value Units
Under the Physician Fee
Schedule (CMS-1582-PN).
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Substance Abuse and Mental Health Services Administration (SAMHSA)
Final Rule Stage
321. Opioid Drugs in Maintenance or Detoxification Treatment of Opiate
Addiction (Section 610 Review)
Legal Authority: 21 U.S.C. 823(9); 42 U.S.C. 257a; 42 U.S.C.
290aa(d); 42 U.S.C. 290dd-2; 42 U.S.C. 300xx-23; 42 U.S.C. 300x-27(a);
42 U.S.C. 300y-11
Abstract: This rule would amend the Federal opioid treatment
program regulations. It would modify the dispensing requirements for
buprenorphine and buprenorphine combination products that are approved
by the Food and Drug Administration (FDA) for opioid dependence and
used in federally certified and registered opioid treatment programs.
Timetable:
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Action Date FR Cite
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NPRM................................ 06/19/09 74 FR 29153
NPRM Comment Period End............. 08/18/09
Final Action........................ 02/00/12
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Regulatory Flexibility Analysis Required: No.
Agency Contact: Nicholas Reuter, Department of Health and Human
Services, Substance Abuse and Mental Health Services Administration,
Suite 2-1063, One Choke Cherry Road, Rockville, MD 20857, Phone: 240
276-2716, Email: [email protected].
RIN: 0930-AA14
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Disease Control and Prevention (CDC)
Proposed Rule Stage
322. Establishment of Minimum Standards for Birth Certificates
Legal Authority: 42 U.S.C. 264
Abstract: Section 7211 of the Intelligence Reform and Terrorism
Prevention Act (IRTPA) mandates that HHS establish, by regulation,
minimum standards to improve the security of birth certificates for use
by Federal agencies for official purposes.
Timetable:
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Action Date FR Cite
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NPRM................................ 09/00/12
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Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Charles Rothwell, Director, Division of Vital
Statistics, Department of Health and Human Services, Centers for
Disease Control and Prevention, 3311 Toledo Road, Room 7311, M,
Hyattsville, MD 20782, Phone: 301 458-4555.
RIN: 0920-AA46
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Disease Control and Prevention (CDC)
Long-Term Actions
323. Control of Communicable Diseases: Foreign
Legal Authority: 42 U.S.C. 243; 42 U.S.C. 264 and 265; 42 U.S.C.
267 and 268; 42 U.S.C. 270 and 271
Abstract: The final rule focuses primarily on requirements relating
to the reporting of deaths and illnesses onboard aircrafts and ships
traveling from foreign countries into the United States, and the
collection of specific traveler contact information for the purpose of
CDC contacting travelers in the event of an exposure to a communicable
disease.
Timetable:
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Action Date FR Cite
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NPRM................................ 11/30/05 70 FR 71892
NPRM Comment Period End............. 01/20/06
-----------------------------------
Final Action........................ To Be Determined
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Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Ashley Marrone, Public Health Analyst, Department
of Health and Human Services, Centers for Disease Control and
Prevention, MS-E03, 1600 Clifton Road NE., Atlanta, GA 30329, Phone:
404 498-1600, Email: [email protected].
[[Page 7949]]
RIN: 0920-AA12
324. Control of Communicable Diseases: Interstate
Legal Authority: 28 U.S.C. 198; 28 U.S.C. 231; 25 U.S.C. 1661; 42
U.S.C. 243; 42 U.S.C. 248 and 249; 42 U.S.C. 264; 42 U.S.C. 266 to 268;
42 U.S.C. 270 to 272; 42 U.S.C. 2001
Abstract: This rule focuses primarily on requirements relating to
the reporting of deaths and illnesses onboard aircrafts traveling
domestically, and the collection of specific traveler contact
information for the purpose of CDC contacting travelers in the event of
an exposure to a communicable disease.
Timetable:
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Action Date FR Cite
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NPRM................................ 11/30/05 70 FR 71892
NPRM Comment Period End............. 01/30/06
-----------------------------------
Final Action........................ To Be Determined
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Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Ashley Marrone, Public Health Analyst, Department
of Health and Human Services, Centers for Disease Control and
Prevention, MS-E03, 1600 Clifton Road NE., Atlanta, GA 30329, Phone:
404 498-1600, Email: [email protected].
RIN: 0920-AA22
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Prerule Stage
325. Over-the-Counter (OTC) Drug Review--Sunscreen Products
Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
Abstract: The OTC drug review establishes conditions under which
OTC drugs are considered generally recognized as safe and effective and
not misbranded. After a final monograph (i.e., final rule) is issued,
only OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. The first of
the future actions will address the safety of sunscreen active
ingredients. The second of the future actions will address active
ingredients reviewed under time and extent applications. The last
action addresses combination products containing sunscreen and insect
repellent ingredients.
Timetable:
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Action Date FR Cite
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ANPRM (Sunscreen and Insect 02/22/07 72 FR 7941
Repellent).
ANPRM Comment Period End............ 05/23/07 .......................
NPRM (UVA/UVB)...................... 08/27/07 72 FR 49070
NPRM Comment Period End............. 12/26/07 .......................
Final Action (UVA/UVB).............. 06/17/11 76 FR 35620
NPRM (Effectiveness)................ 06/17/11 76 FR 35672
NPRM (Effectiveness) Comment Period 09/15/11 .......................
End.
ANPRM (Dosage Forms)................ 06/17/11 76 FR 35669
ANPRM (Dosage Forms) Comment Period 09/15/11 .......................
End.
ANPRM (Safety)...................... 06/00/12 .......................
NPRM (Time and Extent Applications). 08/00/12 .......................
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Regulatory Flexibility Analysis Required: Yes.
Agency Contact: David Eng, Department of Health and Human Services,
Food and Drug Administration, Center for Drug Evaluation and Research,
WO 22, Room 5487, 10903 New Hampshire Avenue, Silver Spring, MD 20993,
Phone: 301 796-2773, Fax: 301 796-9899, Email: [email protected].
RIN: 0910-AF43
326. Prescription Drug Marketing Act of 1987; Prescription Drug
Amendments of 1992; Policies, Requirements, and Administrative
Procedures (Section 610 Review)
Legal Authority: 21 U.S.C. 331; 21 U.S.C. 333; 21 U.S.C. 351; 21
U.S.C. 352; 21 U.S.C. 353; 21 U.S.C. 360; 21 U.S.C. 371; 21 U.S.C. 374;
21 U.S.C. 381
Abstract: Pursuant to section 610 of the Regulatory Flexibility
Act, FDA is currently undertaking a review of regulations promulgated
under the Prescription Drug Marketing Act (PDMA) including those
contained in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as
amended in 64 FR 67762 and 67763). The purpose of this review is to
determine whether the regulations in 21 CFR part 203 and 21 CFR
sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) should
be continued without change, or whether they should be amended or
rescinded, consistent with the stated objectives of applicable
statutes, to minimize adverse impacts on a substantial number of small
entities. FDA solicited comments on the following: (1) The continued
need for the regulations in 21 CFR part 203 and 21 CFR sections 205.3
and 205.50 (as amended in 64 FR 67762 and 67763); (2) the nature of
complaints or comments received from the public concerning the
regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as
amended in 64 FR 67762 and 67763); (3) the complexity of the
regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as
amended in 64 FR 67762 and 67763); (4) the extent to which the
regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as
amended in 64 FR 67762 and 67763) overlap, duplicate, or conflict with
other Federal rules, and to the extent feasible, with State and local
governmental rules, and (5) the degree to which technology, economic
conditions, or other factors have changed in the area affected by the
regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as
amended in 64 FR 67762 and 67763).
Last year, FDA extended the completion date by one year due to the
RxUSA Wholesale, Inc., v. HHS case. Since then, the case has ended and
FDA proposed to withdraw section 203.50(a). Therefore, FDA will
complete the review by December 2011.
Timetable:
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Action Date FR Cite
------------------------------------------------------------------------
Begin Review of Current Regulation.. 11/24/08 .......................
End Review of Current Regulation.... 12/00/11 .......................
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Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Howard Muller, Office of Regulatory Policy,
Department of Health and Human Services, Food and Drug Administration,
Center for Drug Evaluation and Research, WO 51, Room 6234, 10903 New
Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3601,
Fax: 301 847-8440, Email: pdma610(c)[email protected].
RIN: 0910-AG14
327. Requirements for Testing Human Blood Donors for Evidence of
Infection Due to Communicable Disease Agents (Section 610 Review)
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 360c and 360d; 21 U.S.C.
360h and 360i; 21 U.S.C. 371 and 372; 21 U.S.C. 374; 21 U.S.C. 381; 42
U.S.C. 216; 42 U.S.C. 262 to 264; 42 U.S.C. 263; 42 U.S.C. 263a; 42
U.S.C. 264
Abstract: FDA is undertaking a review of 21 CFR sections 610.40,
610.41,
[[Page 7950]]
610.42, 610.44, 640.67, 640.70 (as amended in 66 FR 31146) under
section 610 of the Regulatory Flexibility Act. The purpose of this
review is to determine whether the regulations in 21 CFR sections
610.40, 610.41, 610.42, 610.44, 640.67, 640.70 (as amended in 66 FR
31146) should be continued without change, or whether they should be
amended or rescinded, consistent with the stated objectives of
applicable statutes, to minimize adverse impacts on a substantial
number of small entities. FDA will consider, and is soliciting comments
on, the following: (1) The continued need for the rule; (2) the nature
of complaints or comments received concerning the rule from the public;
(3) the complexity of the rule; (4) the extent to which the rule
overlaps, duplicates, or conflicts with other Federal rules, and, to
the extent feasible, with State and local governmental rules; and (5)
the length of time since the rule has been evaluated or the degree to
which technology, economic conditions, or other factors have changed in
the area affected by the rule.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Begin Review of Current Regulation.. 06/01/11 .......................
End Review of Current Regulation.... 12/00/11 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Melissa Reisman, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Biologics Evaluation and Research, Suite 200N (HFM-17), 1401 Rockville
Pike, Rockville, MD 20852, Phone: 301 827-6210.
RIN: 0910-AG61
328. General Requirements for Blood, Blood Components, and Blood
Derivatives; Donor Notification (Section 610 Review)
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 and
352; 21 U.S.C. 355; 21 U.S.C. 360 and 360j; 21 U.S.C. 371; 21 U.S.C.
374; 42 U.S.C. 216; 42 U.S.C. 262; 42 U.S.C. 263a; 42 U.S.C. 264; * * *
Abstract: FDA is undertaking a review of 21 CFR sections
606.100(b), 606.160(b) and 630.6 (as amended in 66 FR 31165) under
section 610 of the Regulatory Flexibility Act. The purpose of this
review is to determine whether the regulations in 21 CFR sections
606.100(b), 606.160(b) and 630.6 (as amended in 66 FR 31165) should be
continued without change, or whether they should be amended or
rescinded, consistent with the stated objectives of applicable
statutes, to minimize adverse impacts on a substantial number of small
entities. FDA will consider, and is soliciting comments on, the
following: (1) The continued need for the rule; (2) the nature of
complaints or comments received concerning the rule from the public;
(3) the complexity of the rule; (4) the extent to which the rule
overlaps, duplicates, or conflicts with other Federal rules, and, to
the extent feasible, with State and local governmental rules; and (5)
the length of time since the rule has been evaluated or the degree to
which technology, economic conditions, or other factors have changed in
the area affected by the rule.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Begin Review........................ 06/01/11 .......................
End Review.......................... 12/00/11 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Agency Contact: Melissa Reisman, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Biologics Evaluation and Research, Suite 200N (HFM-17), 1401 Rockville
Pike, Rockville, MD 20852, Phone: 301 827-6210.
RIN: 0910-AG62
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Proposed Rule Stage
329. Electronic Submission of Data From Studies Evaluating Human Drugs
and Biologics
Regulatory Plan: This entry is Seq. No. 33 in part II of this issue
of the Federal Register.
RIN: 0910-AC52
330. Over-the-Counter (OTC) Drug Review--Internal Analgesic Products
Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371; 21 U.S.C. 374; 21
U.S.C. 379e
Abstract: The OTC drug review establishes conditions under which
OTC drugs are considered generally recognized as safe and effective and
not misbranded. After a final monograph (i.e., final rule) is issued,
only OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. The first
action addresses acetaminophen safety. The second action addresses
products marketed for children under 2 years old and weight- and age-
based dosing for children's products.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM (Amendment) (Required Warnings 12/26/06 71 FR 77314
and Other Labeling).
NPRM Comment Period End............. 05/25/07 .......................
Final Action (Required Warnings and 04/29/09 74 FR 19385
Other Labeling).
Final Action (Correction)........... 06/30/09 74 FR 31177
Final Action (Technical Amendment).. 11/25/09 74 FR 61512
NPRM (Acetaminophen)................ 06/00/12 .......................
NPRM (Amendment) (Pediatric)........ 12/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Mary Chung, Department of Health and Human
Services, Food and Drug Administration, Center for Drug Evaluation and
Research, WO 22, Room 5488, 10903 New Hampshire Avenue, Silver Spring,
MD 20993, Phone: 301 796-0260, Fax: 301 796-9899, Email:
[email protected].
RIN: 0910-AF36
331. Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug
Products
Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
Abstract: The OTC drug review establishes conditions under which
OTC drugs are considered generally recognized as safe and effective and
not misbranded. After a final monograph (i.e., final rule) is issued,
only OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. The first
action addresses consumer products. The second action addresses testing
requirements.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM (Healthcare)................... 06/17/94 59 FR 31402
Comment Period End.................. 12/15/95 .......................
[[Page 7951]]
NPRM (Consumer)..................... 04/00/12 .......................
-----------------------------------
NPRM (Food Handlers)................ To Be Determined
NPRM (Testing)...................... To Be Determined
Final Action (Consumer)............. To Be Determined
Final Action (Testing).............. To Be Determined
Final Action (Food Handlers)........ To Be Determined
Final Action (First Aid Antiseptic). To Be Determined
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: David Eng, Department of Health and Human Services,
Food and Drug Administration, Center for Drug Evaluation and Research,
WO 22, Room 5487, 10903 New Hampshire Avenue, Silver Spring, MD 20993,
Phone: 301 796-2773, Fax: 301 796-9899, Email: [email protected].
RIN: 0910-AF69
332. Import Tolerances for Residues of Unapproved New Animal Drugs in
Food
Legal Authority: 21 U.S.C. 342; 21 U.S.C. 360b(a)(6); 21 U.S.C. 371
Abstract: The Food and Drug Administration (FDA) plans to publish a
proposed rule related to the implementation of the import tolerances
provision of the Animal Drug Availability Act of 1996 (ADAA). The ADAA
authorizes FDA to establish tolerances for unapproved new animal drugs
where edible portions of animals imported into the United States may
contain residues of such drugs (import tolerances). It is unlawful to
import animal-derived food that bears or contains residues of a new
animal drug that is not approved in the United States, unless FDA has
established an import tolerance for that new animal drug and the
residue of the new animal drug in the animal-derived food does not
exceed that tolerance.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/00/12 .......................
NPRM Comment Period End............. 06/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Thomas Moskal, Consumer Safety Officer, Department
of Health and Human Services, Food and Drug Administration, Center for
Veterinary Medicine, Room 101, (MPN-4, HFV-232), 7519 Standish Place,
Rockville, MD 20855, Phone: 240 276-9242, Fax: 240 276-9241, Email:
[email protected].
RIN: 0910-AF78
333. Laser Products; Amendment to Performance Standard
Legal Authority: 21 U.S.C. 360hh to 360ss; 21 U.S.C. 371; 21 U.S.C.
393
Abstract: FDA is proposing to amend the performance standard for
laser products to achieve closer harmonization between the current
standard and the International Electrotechnical Commission (IEC)
standard for laser products and medical laser products. The proposed
amendment is intended to update FDA's performance standard to reflect
advancements in technology. The proposal would adopt portions of an IEC
standard to achieve greater harmonization and reflect current science.
In addition, the proposal would include an alternative mechanism for
providing certification and identification, address novelty laser
products, and clarify the military exemption for laser products.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Nancy Pirt, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire
Avenue, Silver Spring, MD 20993, Phone: 301 796-6248, Fax: 301 847-
8145, Email: [email protected].
RIN: 0910-AF87
334. Current Good Manufacturing Practice and Hazard Analysis and Risk-
Benefit Preventive Controls for Food for Animals
Regulatory Plan: This entry is Seq. No. 34 in part II of this issue
of the Federal Register.
RIN: 0910-AG10
335. Over-the-Counter (OTC) Drug Review--Pediatric Dosing for Cough/
Cold Products
Legal Authority: 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C.
355; 21 U.S.C. 360; 21 U.S.C. 371
Abstract: The OTC drug review establishes conditions under which
OTC drugs are considered generally recognized as safe and effective and
not misbranded. After a final monograph (i.e., final rule) is issued,
only OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. This action
will propose changes to the final monograph to address safety and
efficacy issues associated with pediatric cough and cold products.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Mary Chung, Department of Health and Human
Services, Food and Drug Administration, Center for Drug Evaluation and
Research, WO 22, Room 5488, 10903 New Hampshire Avenue, Silver Spring,
MD 20993, Phone: 301 796-0260, Fax: 301 796-9899, Email:
[email protected].
RIN: 0910-AG12
336. Electronic Distribution of Content of Labeling for Human
Prescription Drug and Biological Products
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21
U.S.C. 352; 21 U.S.C. 353; 21 U.S.C. 355; 21 U.S.C. 358; 21 U.S.C. 360;
21 U.S.C. 360b; 21 U.S.C. 360gg to 360ss; 21 U.S.C. 371; 21 U.S.C. 374;
21 U.S.C. 379e; 42 U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 262; 42 U.S.C.
264
Abstract: This rule would require electronic package inserts for
human drug and biological prescription products with limited exception,
in lieu of paper, which is currently used. These inserts contain
prescribing information intended for healthcare practitioners. This
would ensure that the information accompanying the product is the most
up-to-date information regarding important safety and efficacy issues
about these products.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/11 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Megan Clark-Velez, Policy Analyst, Department of
Health and Human Services, Food and Drug Administration, Office of
Policy, WO Building 32, Room 4249, 10903 New Hampshire Avenue, Silver
Spring, MD 20993, Phone: 301 796-9301, Email: [email protected].
RIN: 0910-AG18
[[Page 7952]]
337. Amendment to the Current Good Manufacturing Practice Regulations
for Finished Pharmaceuticals--Second Phase
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 351; 21 U.S.C. 352; 21
U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C.
262; 42 U.S.C. 264
Abstract: The Food and Drug Administration (FDA) periodically
reassesses and revises the cGMP regulations to accommodate advances in
technology and other scientific knowledge that further safeguard the
drug manufacturing process and the public health. In August 2002, FDA
announced the Pharmaceutical cGMPs for the 21st Century Initiative. As
part of the Initiative, FDA created a cGMP Harmonization Analysis
Working Group to analyze related cGMP requirements in the United States
and internationally. The cGMP working group compared 21 CFR parts 210
and 211 with the cGMPs of the European Union, as well as other FDA
regulations (such as the Quality Systems Regulation in 21 CFR part 820)
to identify differences and consider the value of supplementing or
changing the current regulations. Based on the cGMP Working Group's
analysis, FDA decided to take an incremental approach to modifying 21
CFR parts 210 and 211. In September of 2008, FDA published a final rule
revising the cGMP regulations primarily in the areas of aseptic
processing, use of asbestos filters, and verification of operations by
a second individual; this final rule represented the culmination of the
first increment of modifications to the cGMP regulations. The proposed
rule identified on this Unified Agenda would begin the second increment
of modifications to the cGMP regulations.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: S. Mitchell Weitzman, Regulatory Counsel, Office of
Regulatory Policy, Department of Health and Human Services, Food and
Drug Administration, Center for Drug Evaluation and Research, WO 51,
Room 6318, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone:
301 796-3511, Fax: 301 847-8440, Email: [email protected].
RIN: 0910-AG20
338. Unique Device Identification
Regulatory Plan: This entry is Seq. No. 35 in part II of this issue
of the Federal Register.
RIN: 0910-AG31
339. Produce Safety Regulation
Regulatory Plan: This entry is Seq. No. 36 in part II of this issue
of the Federal Register.
RIN: 0910-AG35
340. Hazard Analysis and Risk-Based Preventive Controls
Regulatory Plan: This entry is Seq. No. 37 in part II of this issue
of the Federal Register.
RIN: 0910-AG36
341. ``Tobacco Products'' Subject to the Federal Food, Drug, and
Cosmetic Act as Amended by the Family Smoking Prevention and Tobacco
Control Act
Legal Authority: 21 U.S.C. 301 et seq., The Federal Food, Drug, and
Cosmetic Act; Pub. L. 111-31, The Family Smoking Prevention and Tobacco
Control Act
Abstract: The Family Smoking Prevention and Tobacco Control Act
(Tobacco Control Act) provides FDA authority to regulate cigarettes,
cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.
Section 901 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as
amended by the Tobacco Control Act, permits FDA to issue regulations
deeming other tobacco products to be subject to the FD&C Act. This
proposed rule would deem products meeting the statutory definition of
``tobacco product'' found at section 201(rr) of the FD&C Act to be
subject to Chapter IX of the FD&C Act and would clarify additional
restrictions under the FD&C Act. The scope of the proposed rule deeming
cigars that was previously included in the Unified Agenda is being
broadened to encompass products that meet the statutory definition of
``tobacco product.''
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/11 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: May Nelson, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, 9200 Corporate
Boulevard, Rockville, MD 20850, Phone: 877 287-1373, Fax: 240 276-3904,
Email: [email protected].
RIN: 0910-AG38
342. Human Subject Protection; Acceptance of Data From Clinical Studies
for Medical Devices
Legal Authority: Not Yet Determined.
Abstract: The Food and Drug Administration (FDA) is proposing to
amend its regulations on acceptance of data from clinical studies
conducted in support of a premarket approval application, humanitarian
device exemption application, an investigational device exemption
application, or a premarket notification submission for a medical
device.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Sheila Anne Brown, Policy Analyst, Investigational
Device Exemptions Staff, Department of Health and Human Services, Food
and Drug Administration, WO 66, Room 1651, 10903 New Hampshire Avenue,
Silver Spring, MD 20993, Phone: 301 796-6563, Fax: 301 847-8120, Email:
[email protected].
RIN: 0910-AG48
343. General Hospital and Personal Use Devices: Issuance of Draft
Special Controls Guidance for Infusion Pumps
Legal Authority: 21 U.S.C. 351; 21 U.S.C. 360; 21 U.S.C. 360c; 21
U.S.C. 360e; 21 U.S.C. 360j; 21 U.S.C. 371
Abstract: Since 2003, FDA has seen a dramatic increase in the
number of device recalls, as well as an increase in the number of death
and serious injury reports submitted regarding infusion pumps. An
analysis of the reports reveals that a majority of the recalls and
failures were caused by user error and/or device design flaw. As a
result of these incidents, FDA is proposing to change the
classification of infusion pumps from class II (performance standards)
to class II (special controls). Along with the proposed rule, FDA plans
to announce a draft special controls guidance document that, when
final, will be a special control for infusion pumps. The agency
believes that establishing these special controls for infusion pumps is
necessary to provide reasonable assurance of the safety and
effectiveness of these devices.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/00/12 .......................
NPRM Comment Period End............. 08/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Nancy Pirt, Regulatory Counsel, Department of
Health and Human Services, Food and
[[Page 7953]]
Drug Administration, Center for Devices and Radiological Health, WO 66
Room 4438, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone:
301 796-6248, Fax: 301 847-8145, Email: [email protected].
RIN: 0910-AG54
344. Requirements for the Testing and Reporting of Tobacco Product
Constituents, Ingredients, and Additives
Legal Authority: Pub. L. 111-31, The Family Smoking Prevention and
Tobacco Control Act, sec 101(b)
Abstract: Section 915 of the Federal Food, Drug, and Cosmetic Act,
as amended by the Family Smoking Prevention and Tobacco Control Act,
requires FDA to promulgate regulations that require the testing and
reporting of tobacco product constituents, ingredients, and additives,
including smoke constituents that the agency determines should be
tested to protect the public health.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/00/12 .......................
NPRM Comment Period End............. 10/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Carol Drew, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Rm 240 H, 9200
Corporate Boulevard, Rockville, MD 20850, Phone: 877 287-1373, Fax: 240
276-3904, Email: [email protected].
RIN: 0910-AG59
345. Amendments to the Current Good Manufacturing Practice Regulations
for Finished Pharmaceuticals--Components
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 351; 21 U.S.C. 352; 21
U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C.
262; 42 U.S.C. 264
Abstract: This rule proposes to amend regulations regarding the
control over components used in manufacturing finished pharmaceuticals.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Brian Hasselbalch, Consumer Safety Officer,
Department of Health and Human Services, Food and Drug Administration,
Center for Drug Evaluation and Research, WO 51, Room 4364, 10903 New
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3279, Email:
[email protected].
Paula Katz, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO 51, Room
1320, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301
796-6972, Email: [email protected].
RIN: 0910-AG70
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Final Rule Stage
346. Infant Formula: Current Good Manufacturing Practices; Quality
Control Procedures; Notification Requirements; Records and Reports; and
Quality Factors
Regulatory Plan: This entry is Seq. No. 40 in part II of this issue
of the Federal Register.
RIN: 0910-AF27
347. Label Requirement for Food That Has Been Refused Admission Into
the United States
Legal Authority: 15 U.S.C. 1453 to 1455; 21 U.S.C. 321; 21 U.S.C.
342 and 343; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381; 42 U.S.C.
216; 42 U.S.C. 264
Abstract: The final rule will require owners or consignees to label
imported food that is refused entry into the United States. The label
will read, ``UNITED STATES: REFUSED ENTRY.'' The proposal describes the
label's characteristics (such as its size) and processes for verifying
that the label has been affixed properly. We are taking this action to
prevent the introduction of unsafe food into the United States, to
facilitate the examination of imported food, and to implement section
308 of the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188).
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 09/18/08 73 FR 54106
NPRM Comment Period End............. 12/02/08 .......................
Final Action........................ 06/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Daniel Sigelman, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, WO Building
32, Room 4254, 10903 New Hampshire Avenue, Silver Spring, MD 20993,
Phone: 301 796-4706, Email: [email protected].
RIN: 0910-AF61
348. Food Labeling: Nutrition Labeling for Food Sold in Vending
Machines
Regulatory Plan: This entry is Seq. No. 43 in part II of this issue
of the Federal Register.
RIN: 0910-AG56
349. Food Labeling: Nutrition Labeling of Standard Menu Items in
Restaurants and Similar Retail Food Establishments
Regulatory Plan: This entry is Seq. No. 44 in part II of this issue
of the Federal Register.
RIN: 0910-AG57
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Long-Term Actions
350. Food Labeling; Revision of the Nutrition and Supplement Facts
Labels
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371
Abstract: In the Federal Register of July 11, 2003 (68 FR 41507),
FDA published an ANPRM (the 2003 ANPRM) to solicit information and data
on trans fat labeling and claims made about trans fats. Comments
received to the 2003 ANPRM that pertain to the labeling of trans fat
will be addressed in this proposed rule. In addition, the Agency
published an ANPRM on the prominence of calories on the food label on
April 4, 2005 (the 2005 ANPRM) (70 FR 17008), and an ANPRM on the
revision of reference values and mandatory nutrients on November 2,
2007 (the 2007 ANPRM) (72 FR 62149). The Agency also intends to address
the comments received to the 2005 and 2007 ANPRM's in this proposed
rule.
FDA is proposing to amend labeling regulations for conventional
foods and dietary supplements to provide updated nutrition information
on the label to assist consumers in maintaining healthy dietary
practices. Mandatory nutrition labeling of food was first required in
1993. Much of the information found on the Nutrition Facts label has
not been updated since that time. If finalized, this rule will
modernize the nutrition information found on the Nutrition Facts label,
as well as the format and appearance of the label.
Among the changes proposed, the Agency intends to: (1) Provide
updated
[[Page 7954]]
Daily Reference values (DRVs) and Reference Daily Intake values (RDIs)
that are based on the latest scientific evidence from consensus
reports, such as the Institute of Medicine Dietary Reference Intakes;
(2) provide DRVs and RDIs, as well as requirements for foods purported
to be for children under 4 years of age and pregnant or lactating
women; and (3) make changes to the mandatory declaration of specific
nutrients. The Agency is also considering revisions to the format and
appearance of the Nutrition Facts label and the Supplement Facts label,
including the prominence of calories on the label.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 07/11/03 68 FR 41507
ANPRM Comment Period End............ 10/09/03 .......................
ANPRM............................... 04/04/05 70 FR 17008
ANPRM Comment Period End............ 06/20/05 .......................
ANPRM............................... 11/02/07 72 FR 62149
ANPRM Comment Period End............ 01/31/08 .......................
NPRM................................ 12/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Blakeley Fitzpatrick, Interdisciplinary Scientist,
Department of Health and Human Services, Food and Drug Administration,
Center for Food Safety and Applied Nutrition (HFS-830), HFS-830, 5100
Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1450,
Email: [email protected].
RIN: 0910-AF22
351. Over-the-Counter (OTC) Drug Review--Oral Health Care Products
Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355; 21 U.S.C. 360 to 360a; 21 U.S.C. 371 to 371a
Abstract: The OTC drug review establishes conditions under which
OTC drugs are considered generally recognized as safe and effective and
not misbranded. After a final monograph (i.e., final rule) is issued,
only OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. The NPRM and
final action will address oral health care products used to reduce or
prevent dental plaque and gingivitis.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM (Plaque Gingivitis)........... 05/29/03 68 FR 32232
ANPRM Comment Period End............ 08/27/03 .......................
-----------------------------------
NPRM (Benzocaine)................... To Be Determined
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: David Eng, Department of Health and Human Services,
Food and Drug Administration, Center for Drug Evaluation and Research,
WO 22, Room 5487, 10903 New Hampshire Avenue, Silver Spring, MD 20993,
Phone: 301 796-2773, Fax: 301 796-9899, Email: [email protected].
RIN: 0910-AF40
352. Pet Food Labeling Requirements
Legal Authority: 21 U.S.C. 343; 21 U.S.C. 371; Pub. L. 110-85, sec
1002(a)(3)
Abstract: The President signed into law the Food and Drug
Administration Amendments Act of 2007 (FDAAA) on September 27, 2007
(Pub. L. 110-85). Title X of the FDAAA includes several provisions
pertaining to food safety, including the safety of pet food. Section
1002(a)(3) of the new law directs FDA to issue new regulations to
establish updated standards for the labeling of pet food that include
nutritional and ingredient information. This same provision of the law
also directs that, in developing these new regulations, FDA consult
with the Association of American Feed Control Officials and other
relevant stakeholder groups, including veterinary medical associations,
animal health organizations, and pet food manufacturers.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ To Be Determined
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: William Burkholder, Veterinary Medical Officer,
Department of Health and Human Services, Food and Drug Administration,
Center for Veterinary Medicine, Room 2642 (MPN-4, HFV-228), 7519
Standish Place, Rockville, MD 20855, Phone: 240 453-6865, Email:
[email protected].
RIN: 0910-AG09
353. Further Amendments to General Regulation of the Food and Drug
Administration To Incorporate Tobacco Products
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 333; 21
U.S.C. 371; 21 U.S.C. 381; 21 U.S.C. 387; 21 U.S.C. 387a; 21 U.S.C.
387c; 21 U.S.C. 387f; 21 U.S.C. 387k; 15 U.S.C. 1333; 15 U.S.C. 4402
Abstract: The Food and Drug Administration is seeking to amend
certain of its general regulations to include tobacco products, where
appropriate, in light of FDA's authority to regulate these products
under the Family Smoking Prevention and Tobacco Control Act. The final
rule will cover revisions to the document reporting requirements and
definition of ``product.''
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/14/11 76 FR 20901
NPRM Comment Period End............. 06/13/11 .......................
-----------------------------------
Final Action........................ To Be Determined
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Gerie Voss, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, 9200 Corporate
Boulevard, Rockville, MD 20850, Phone: 877 287-1373,Fax: 240 276-4193,
Email: [email protected].
RIN: 0910-AG60
354. Food Labeling: Hard Candies and Breath Mints
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371
Abstract: The Food and Drug Administration is proposing to amend
certain provisions of its serving size regulations to change the label
serving size for breath mints to one unit. This action is in response
to an advanced notice of proposed rulemaking published in 2005, in
which FDA requested comment on whether to amend certain provisions of
its nutrition labeling regulations concerning serving size and a 1997
proposed rule entitled Food Labeling: Hard Candies and Breath Mints (62
FR 67775).
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/30/97 62 FR 67775
NPRM Comment Period End............. 03/16/98 .......................
ANPRM............................... 04/05/05 70 FR 17010
ANPRM Comment Period End............ 06/20/05 .......................
[[Page 7955]]
NPRM................................ 12/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Mark Kantor, Nutritionist, Department of Health and
Human Services, Food and Drug Administration, 5100 Paint Branch
Parkway, HFS-830, College Park, MD 20740, Phone: 240 402-1450, Fax: 301
436-1191, Email: [email protected].
RIN: 0910-AG82
355. Food Labeling; Serving Sizes; Reference Amounts for
Candies
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371
Abstract: The Food and Drug Administration is proposing to amend
certain provisions of its serving size regulations to provide updated
Reference Amounts Customarily Consumed for candies. This action is in
response to an advance notice of proposed rulemaking published in 2005,
in which FDA requested comment on whether to amend certain provisions
of its nutrition labeling regulations concerning serving size and a
1998 proposed rule entitled ``Food Labeling: Reference Amounts for
Candies'' (63 FR 1078).
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/08/98 63 FR 1078
NPRM Comment Period End............. 02/09/98 .......................
ANPRM............................... 04/05/05 70 FR 17010
ANPRM Comment Period End............ 06/20/05 .......................
NPRM................................ 12/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Mark Kantor, Nutritionist, Department of Health and
Human Services, Food and Drug Administration, 5100 Paint Branch
Parkway, HFS-830, College Park, MD 20740, Phone: 240 402-1450, Fax: 301
436-1191, Email: [email protected].
RIN: 0910-AG83
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Completed Actions
356. Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator)
Products
Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
Abstract: The OTC drug review establishes conditions under which
OTC drugs are considered generally recognized as safe and effective and
not misbranded. After a final monograph (i.e., final rule) is issued,
only OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. This action
addresses labeling for single ingredient bronchodilator products.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM (Amendment--Ephedrine Single 07/13/05 70 FR 40237
Ingredient).
NPRM Comment Period End............. 11/10/05 .......................
Final Action (Technical Amendment).. 11/30/07 72 FR 67639
Final Action (Amendment--Single 07/26/11 76 FR 44475
Ingredient Labeling).
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Mary Chung, Department of Health and Human
Services, Food and Drug Administration, Center for Drug Evaluation and
Research, WO 22, Room 5488, 10903 New Hampshire Avenue, Silver Spring,
MD 20993, Phone: 301 796-0260, Fax: 301 796-9899, Email:
[email protected].
RIN: 0910-AF32
357. Over-the-Counter (OTC) Drug Review--Poison Treatment Drug Products
Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
Abstract: The OTC drug review establishes conditions under which
OTC drugs are considered generally recognized as safe and effective and
not misbranded. After a final monograph (i.e., final rule) is issued,
only OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. This action
addresses the ingredient ipecac syrup.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Withdrawn........................... 09/08/11 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: David Eng, Department of Health and Human Services,
Food and Drug Administration, Center for Drug Evaluation and Research,
WO 22, Room 5487, 10903 New Hampshire Avenue, Silver Spring, MD 20993,
Phone: 301 796-2773, Fax: 301 796-9899, Email: [email protected].
RIN: 0910-AF68
358. Cigarette Warning Label Statements
Legal Authority: Pub. L. 111-31, The Family Smoking Prevention and
Tobacco Control Act, sec 201
Abstract: Section 4 of the FCLAA, as amended by section 201 of the
Tobacco Control Act, requires FDA to issue regulations that require
color graphics depicting the negative health consequences of smoking to
accompany required warning statements on cigarette packages and
advertisements. FDA also may adjust the type size, text and format of
the required label statements on product packaging and advertising if
FDA determines that it is appropriate so that both the graphics and the
accompanying label statements are clear, conspicuous, legible and
appear within the specified area.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 11/12/10 75 FR 69524
NPRM Comment Period End............. 01/11/11 .......................
Final Action........................ 06/22/11 76 FR 36628
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Gerie Voss, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, 9200 Corporate
Boulevard, Rockville, MD 20850, Phone: 877 287-1373, Fax: 240 276-4193,
Email: [email protected].
RIN: 0910-AG41
[[Page 7956]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Proposed Rule Stage
359. Covered Outpatient Drugs (CMS-2345-P) (Section 610 Review)
Legal Authority: Pub. L. 111-48, secs 2501 and 2503
Abstract: This proposed rule would revise requirements pertaining
to Medicaid reimbursement for covered outpatient drugs to implement
provisions of the Affordable Care Act. This proposed rule would also
revise other requirements related to covered outpatient drugs,
including key aspects of Medicaid coverage, payment, and the drug
rebate program.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Wendy Tuttle, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicaid and State Operations, Mail Stop
S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-
8690, Email: [email protected].
RIN: 0938-AQ41
360. Medicare and Medicaid Electronic Health Record Incentive Program--
Stage 2 (CMS-0044-P)
Legal Authority: Pub. L. 111-5 secs 4101, 4102, and 4202
Abstract: The final rule for the Medicare and Medicaid EHR
Incentive Programs, which was published in the Federal Register on July
28, 2010, specifies that CMS will expand on the criteria for meaningful
use established for Stage 1 to advance the use of certified EHR
technology by eligible professionals (EPs), eligible hospitals and
critical access hospitals (CAHs). This proposed rule would establish
the requirements for Stage 2. As stated in the July 28 final rule,
``Our goals for the Stage 2 meaningful use criteria, consistent with
other provisions of Medicare and Medicaid law, expand upon the Stage 1
criteria to encourage the use of health IT for continuous quality
improvement at the point of care and the exchange of information in the
most structured format possible, such as the electronic transmission of
orders entered using computerized provider order entry (CPOE) and the
electronic transmission of diagnostic test results.''
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 02/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Elizabeth Holland, Director, Health Initiatives
Group/Office of e-Health Standards and Services, Department of Health
and Human Services, Centers for Medicare & Medicaid Services, Mail Stop
S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-
1309, Email: [email protected].
RIN: 0938-AQ84
361. Medicare and Medicaid Programs: Reform of Hospital and Critical
Access Hospital Conditions of Participation (CMS-3244-P)
Regulatory Plan: This entry is Seq. No. 45 in part II of this issue
of the Federal Register.
RIN: 0938-AQ89
362. Proposed Changes to Hospital OPPS and CY 2013 Payment
Rates; ASC Payment System and CY 2013 Payment Rates (CMS-1589-P)
(Section 610 Review)
Regulatory Plan: This entry is Seq. No. 47 in part II of this issue
of the Federal Register.
RIN: 0938-AR10
363. Revisions to Payment Policies Under the Physician Fee
Schedule and Part B for CY 2013 (CMS-1590-P) (Section 610 Review)
Regulatory Plan: This entry is Seq. No. 48 in part II of this issue
of the Federal Register.
RIN: 0938-AR11
364. Changes to the Hospital Inpatient and Long-Term Care
Prospective Payment System for FY 2013 (CMS-1588-P) (Section 610
Review)
Regulatory Plan: This entry is Seq. No. 49 in part II of this issue
of the Federal Register.
RIN: 0938-AR12
365. Transparency Reports and Reporting of Physician Ownership
of Investment Interests (CMS-5060-F)
Legal Authority: Pub. L. 111-148, sec 6002
Abstract: This final rule requires applicable manufacturers of
drugs, devices, biologicals, or medical supplies covered by Medicare,
Medicaid, or CHIP to report annually to the Secretary certain payments
or transfers of value provided to physicians or teaching hospitals
(``covered recipients''). In addition, applicable manufacturers and
applicable group purchasing organizations (GPOs) are required to report
annually certain physician ownership or investment interests. The
Secretary is required to publish applicable manufacturers' and
applicable GPOs' submitted payment and ownership information on a
public Web site.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/19/11 76 FR 78742
NPRM Comment Period End............. 02/17/12 .......................
Final Action........................ 12/00/14 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Niall Brennan, Director, Policy and Data Analysis
Group, Department of Health and Human Services, Centers for Medicare &
Medicaid Services, 7500 Security Blvd., Baltimore, MD 21244, Phone: 202
690-6627, Email: [email protected].
RIN: 0938-AR33
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Completed Actions
366. Proposed Changes to the Hospital Inpatient Prospective Payment
Systems for Acute Care Hospitals and FY 2012 Rates and to the Long-Term
Care Hospital PPS and FY 2012 Rates (CMS-1518-F) (Completion of a
Section 610 Review)
Legal Authority: sec 1886(d) of the Social Security Act; Pub. L.
111-148 secs 3004, 3025
Abstract: This rule revises the Medicare hospital inpatient and
long-term care hospital prospective payment systems for operating and
capital-related costs. This rule implements changes arising from our
continuing experience with these systems.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/05/11 76 FR 25788
NPRM Comment Period End............. 06/20/11 .......................
Final Action........................ 08/18/11 76 FR 51476
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Ankit Patel, Health Insurance Specialist, Division
of Acute Care, Department of Health and Human
[[Page 7957]]
Services, Centers for Medicare & Medicaid Services, Hospital and
Ambulatory Policy Group, Mail Stop, C4-25-11, 7500 Security Boulevard,
Baltimore, MD 21244, Phone: 410 786-4537, Email:
[email protected].
RIN: 0938-AQ24
367. Revisions to Payment Policies Under the Physician Fee Schedule and
Part B for CY 2012 (CMS-1524-FC) (Completion of a Section 610 Review)
Legal Authority: Social Security Act, sec 1102; Social Security
Act, sec 1871; Pub. L. 111-148
Abstract: This annual rule revises payment polices under the
physician fee schedule, as well as other policy changes to payment
under Part B. These changes are applicable to services furnished on or
after January 1.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/19/11 76 FR 42772
NPRM Comment Period End............. 08/30/11 .......................
Final Action........................ 11/28/11 76 FR 73026
Final Action Effective.............. 01/01/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Christina Ritter, Director, Division of
Practitioner Services, Department of Health and Human Services, Centers
for Medicare & Medicaid Services, Mail Stop C4-03-06, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-4636, Email:
[email protected].
RIN: 0938-AQ25
368. Changes to the Hospital Outpatient Prospective Payment System and
Ambulatory Surgical Center Payment System for CY 2012 (CMS-1525-F)
(Completion of a Section 610 Review)
Legal Authority: Social Security Act, sec 1833; Pub. L. 111-148 sec
6001
Abstract: This rule revises the Medicare hospital outpatient
prospective payment system to implement applicable statutory
requirements and changes arising from our continuing experience with
this system. The proposed rule also describes changes to the amounts
and factors used to determine payment rates for services. In addition,
the rule finalizes changes to the Ambulatory Surgical Center Payment
System list of services and rates.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/18/11 76 FR 42170
NPRM Comment Period End............. 08/30/11 .......................
Final Action........................ 11/30/11 76 FR 74122
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Paula Smith, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Mail Stop, C4-05-13, 7500 Security Boulevard,
Baltimore, MD 21244, Phone: 410 786-4709, Email:
[email protected].
RIN: 0938-AQ26
369. Prospective Payment System and Consolidated Billing for Skilled
Nursing Facilities for FY 2012; Required Disclosures of Ownership (CMS-
1351-F) (Completion of a Section 610 Review)
Legal Authority: Social Security Act, sec 1888(e), Pub. L. 111-148,
sec 6101
Abstract: This major rule finalizes two options for updating the
payment rates used under the prospective payment system (SNFs), for
fiscal year 2012. In this context, it examines recent changes in
provider behavior relating to the implementation of the Resource
Utilization Groups, version 4 (RUG-IV) case-mix classification system,
discusses how such changes may affect the objective of maintaining
parity in overall expenditures between RUG-IV and the previous case-mix
classification system, and considers a possible recalibration of the
case-mix indexes so that they more accurately reflect parity in
expenditures. It also includes a discussion of a Non-Therapy Ancillary
component and outlier research currently under development within CMS.
In addition, this rule discusses the impact of certain provisions of
the Affordable Care Act, and new programs and initiatives affecting
SNFs. It also implements section 3401(b) of the Affordable Care Act,
which requires for fiscal year 2012 and subsequent fiscal years that
the SNF market basket percentage change be reduced by the multi-factor
productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of
the Act. It also implements section 6101 of the Affordable Care Act,
which requires Medicare SNFs and Medicaid nursing facilities to
disclose certain information to the Secretary and other entities
regarding the ownership and organizational structure of their
facilities.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/06/11 76 FR 26364
NPRM Comment Period End............. 06/27/11 .......................
Final Action........................ 08/08/11 76 FR 48486
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: William Ullman, Technical Advisor, Department of
Health and Human Services, Centers for Medicare & Medicaid Services,
Centers for Medicare Management, Mail Stop C5-06-27, 7500 Security
Boulvard, Baltimore, MD 21244, Phone: 410 786-5667, Fax: 410 786-0765,
Email: [email protected].
RIN: 0938-AQ29
370. Home Health Prospective Payment System Refinements and Rate Update
for CY 2012 (CMS-1353-F) (Section 610 Review)
Legal Authority: Social Security Act, secs 1102 and 1871; 42 U.S.C.
1302 and 1395(hh); Social Security Act, sec 1895; 42 U.S.C. 1395(fff),
Pub. L. 111-148 secs 3131, 3401, 6407
Abstract: This rule updates the 60-day national episode rate (based
on the applicable Home Health Market Basket Update and case-mix
adjustment) and would also update the national per-visit rates (used to
calculate low utilization payment adjustments (LUPAs) and outlier
payments) amounts under the Medicare Prospective Payment System for
home health agencies. These changes are applicable to services
furnished on or after January 1st.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/12/11 76 FR 40988
NPRM Comment Period End............. 09/06/11 .......................
Final Action........................ 11/04/11 76 FR 68526
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Kelly Horney, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare Management, Mail Stop C5-07-28,
7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-0558, Fax:
410 786-0765, Email: [email protected].
RIN: 0938-AQ30
371. Enhanced Federal Funding for Medicaid Eligibility Determination
and Enrollment Activities (CMS-2346-F)
Legal Authority: Pub. L. 111-148, sec 1413
Abstract: The Affordable Care Act requires States' residents to
apply, enroll, receive determinations, and participate in the State
health subsidy programs known as ``the Exchange''.
[[Page 7958]]
The Affordable Care Act requires many changes to State eligibility and
enrollment systems and each State is responsible for developing a
secure, electronic interface allowing the exchange of data. Existing
legacy eligibility systems are not able to implement the numerous
requirements. This rule is key to informing States about the higher
rates that CMS will provide to help them update or build legacy
eligibility systems that meet the ACA requirements.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 11/08/10 75 FR 68583
NPRM Comment Period End............. 01/07/11 .......................
Final Action........................ 04/19/11 76 FR 21950
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Richard H. Friedman, Director, Division of State
Systems, Department of Health and Human Services, Centers for Medicare
& Medicaid Services, Mail Stop S3-18-13, 7500 Security Boulevard,
Baltimore, MD 21244, Phone: 410 786-4451, Email:
[email protected].
RIN: 0938-AQ53
372. Five-Year Review of Work Relative Value Units Under the Physician
Fee Schedule (CMS-1582-PN)
Legal Authority: SSA, sec 1848(c)(2)(B)(i)
Abstract: This proposed notice sets forth proposed revisions to
work relative value units (RVUs) affecting payment for physicians'
services. The Act requires that we review RVUs no less than every five
years. The revised values will be finalized in the CY 2012 Physician
Fee Schedule final rule and will be effective for services furnished
beginning January 1, 2012.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Notice.............................. 06/06/11 76 FR 32410
Merged With 0938-AQ25............... 07/07/11 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Rebecca Cole, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Mail Stop: C4-03-06, 7500 Security Boulevard,
Baltimore, MD 21244, Phone: 410 786-1589, Email:
[email protected].
RIN: 0938-AQ87
[FR Doc. 2012-1647 Filed 2-10-12; 8:45 am]
BILLING CODE 4150-24-P