[Federal Register Volume 79, Number 65 (Friday, April 4, 2014)]
[Proposed Rules]
[Pages 18867-18868]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-07548]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
[Docket No. FDA-2013-N-1421]
Guidance for Industry on What You Need To Know About
Establishment, Maintenance, and Availability of Records--Small Entity
Compliance Guide; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``What You Need To
Know About Establishment, Maintenance, and Availability of Records--
Small Entity Compliance Guide'' (SECG), which updates an earlier
guidance of the same title. Previously, this guidance restated the
legal requirements of FDA's maintenance and establishment of records
regulation and served as that regulation's SECG. Because the FDA Food
Safety Modernization Act (FSMA) amended FDA's maintenance and
establishment of records regulation, FDA issued an interim final rule
(IFR) amending certain regulations to be consistent with the changes.
Accordingly, FDA is revising this guidance to help any entity comply
with FDA's maintenance and establishment of records requirements,
including the amendments to these requirements made by the IFR as
finalized. This guidance continues to serve as FDA's SECG.
DATES: Submit either electronic or written comments on FDA guidances at
any time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Outreach and Information Center, Center for Food Safety and
Applied Nutrition, Food and Drug Administration (HFS-009), 5100 Paint
Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive
labels to assist that office in processing your request. See the
SUPPLEMENTARY INFORMATION section for electronic access to the
guidance.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: William A. Correll, Jr., Office of
Compliance, Center for Food Safety and Applied Nutrition (HFS-009),
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740, 240-402-1611.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a guidance for industry
entitled ``What You Need To Know About Establishment, Maintenance, and
Availability of Records--Small Entity Compliance Guide (SECG).'' This
guidance is being issued consistent with our good guidance practices
regulation (21 CFR 10.115(c)(2)). The guidance represents our current
thinking on the establishment, maintenance, and availability of
records. It does not create or confer any rights for or on any person
and does not operate to bind FDA or the public. An alternative approach
may be used if such approach satisfies the requirements of the
applicable statutes and regulations.
FSMA (Pub. L. 111-353), among other things, amended FDA's records
access under section 414(a) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act). In the Federal Register of February 23, 2012 (77 FR 10658),
FDA issued an IFR that amended certain requirements on the availability
of records in the regulation on the establishment and maintenance of
records in 21 CFR Part 1, Subpart J to be consistent with amendments to
the FD&C Act made by FSMA. This interim final rule was effective March
1, 2012.
Previously, this guidance restated the legal requirements of FDA's
establishment and maintenance of records regulation at 21 CFR part 1,
Subpart J, implementing section 414 of the FD&C Act, as added by the
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002 (Pub. L. 107-188). This guidance also served as FDA's SECG for
21 CFR Part 1, Subpart J in accordance with section 212 of the Small
Business Regulatory Enforcement Fairness Act (Pub. L. 104-121). Because
section 101 of FSMA amended section 414(a) of the FD&C Act, FDA issued
an IFR amending certain requirements on the availability of records in
21 CFR Part 1, Subpart J. Elsewhere in this issue of the Federal
Register, we are issuing a final rule adopting the IFR without changes.
The final rule is effective upon publication. Accordingly, FDA is
updating this SECG to help any entity comply with the requirements in
21 CFR part 1, Subpart J, including the amendments to 21 CFR Part 1,
Subpart J made by the IFR and adopted as final. This guidance continues
to serve as FDA's SECG for 21 CFR part 1, Subpart J.
The Regulatory Flexibility Act (5 U.S.C. 601-612) requires Agencies
to determine whether a final rule will have a significant impact on
small entities when an Agency issues a final rule ``after being
required . . . to publish a general notice of proposed rulemaking.''
Although FDA is not required to perform a regulatory flexibility
analysis because, in accordance with 5 U.S.C. 553(b)(3)(B) and 21 CFR
10.40(e)(1), the Agency found for good cause that use of prior notice
and comment procedures were contrary to the public interest;
[[Page 18868]]
FDA has nonetheless examined the economic implications of the final
rule in accordance with the Regulatory Flexibility Act and determined
that the final rule will not have a significant economic impact on a
substantial number of small entities. Similarly, because FDA is not
required to perform a final regulatory flexibility analysis under 5
U.S.C 605(b) for the final rule, FDA is not required to issue an SECG
to comply with section 212 of the Small Business Regulatory Enforcement
Fairness Act (Pub. L. 104-121); nevertheless, FDA has updated this SECG
to state in plain language the requirements of 21 CFR part 1, Subpart
J, as amended by the final rule.
II. Paperwork Reduction Act of 1995
This guidance refers to information collection provisions found in
FDA regulations. These collections of information are subject to review
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). Except for the provision
regarding access to records, the collections of information in 21 CFR
part 1, Subpart J, have been approved under OMB control number 0910-
0560. With regard to access to records, we conclude that these
information collection provisions are exempt from OMB review under 44
U.S.C. 3518(c)(1)(B)(ii) and 5 CFR 1320.4(a)(2) as collections of
information obtained during the conduct of a civil action to which the
United States or any official or Agency thereof is a party, or during
the conduct of an administrative action, investigation, or audit
involving an Agency against specific individuals or entities. The
regulations in 5 CFR 1320.3(c) provide that the exception in 5 CFR
1320.4(a)(2) applies during the entire course of the investigation,
audit or action, but only after a case file or equivalent is opened
with respect to a particular party. Such a case file would be opened as
part of the request to access records.
III. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/RegulatoryInformation/Guidances/default.htm
or http://www.regulations.gov.
Dated: April 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07548 Filed 4-3-14; 8:45 am]
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