[Federal Register Volume 78, Number 140 (Monday, July 22, 2013)]
[Rules and Regulations]
[Pages 43817-43820]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17543]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 7

[Docket No. CDC-2013-0013]
RIN 0920-AA53


Distribution of Reference Biological Standards and Biological 
Preparations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Direct final rule and request for comments.

-----------------------------------------------------------------------

SUMMARY: The Centers for Disease Control and Prevention (CDC), located 
within the Department of Health and Human Services (HHS) proposes to 
update four sections of its regulations titled ``Distribution of 
Reference Biological Standards and Biological Preparations'' to update 
the authority citation and reflect the agency's current name, address, 
and contact information for fees schedules and terms of payment. These 
updates will not affect current practices.

DATES: The direct final rule (DFR) is effective on September 20, 2013 
unless significant adverse comment is received by August 21, 2013. If 
we receive no significant adverse comments within the specified comment 
period, we intend to publish a document confirming the effective date 
of the final rule in the Federal Register within 30 days of the 
conclusion of the comment period. If we receive any timely significant 
adverse comment, we will withdraw this DFR in part or in whole by 
publishing a notice in the Federal Register within 30 days of the 
conclusion of the comment period.

ADDRESSES: You may submit comments, identified by ``RIN 0920-AA52'': by 
any of the following methods:
     Internet: Access the Federal e-rulemaking portal at http://www.regulations.gov. Follow the instructions for submitting comments.
     Mail: Division of Scientific Resources, Centers for 
Disease Control and Prevention, 1600 Clifton Road, NE., MS C-17, 
Atlanta, Georgia 30333, ATTN: Part 7 DFR.
    Instructions: All submissions received must include the agency name 
and docket number or Regulation Identifier Number (RIN) for this 
rulemaking. All relevant comments will be posted without change to 
http://regulations.gov, including any personal information provided. 
For detailed instructions on submitting comments and additional 
information on the rulemaking process, see the ``Public Participation'' 
heading of the SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, please go to http://www.regulations.gov. Comments 
will be available for public inspection Monday through Friday, except 
for legal holidays, from 9 a.m. until 5 p.m., Eastern Time, at 1600 
Clifton Road, NE., Atlanta, Georgia 30333. Please call ahead to 404-
639-3466 and ask for a representative in the Division of Scientific 
Resources (DSR) to schedule your visit. To download an electronic 
version of the rule, access http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: For questions concerning this direct 
final rule: Dr. Carolyn M. Black, Director, Division of Scientific 
Resources, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE., Mailstop C-17, Atlanta, Georgia 30333; telephone 404-639-
3466.

[[Page 43818]]


SUPPLEMENTARY INFORMATION: The preamble is organized as follows:

I. Public Participation
II. Authority for these Regulations
III. Why are we doing this rulemaking?
IV. Updates to Part 7
V. Alternatives Considered
VI. Required Regulatory Analyses
    A. Required Regulatory Analyses under Executive Orders 12866 and 
13563
    B. Regulatory Flexibility Act
    C. Small Business Regulatory Enforcement Fairness Act of 1996
    D. The Paperwork Reduction Act of 1995
    E. National Environmental Policy Act (NEPA)
    F. Civil Justice Reform (Executive Order 12988)
    G. Executive Order 13132 (Federalism)
    H. Plain Language Act of 2010

I. Public Participation

    HHS/CDC is publishing a DFR because it does not expect to receive 
any significant adverse comments and believes that these updates add 
clarity to the regulation and are non-controversial. However, 
interested persons may participate in this rulemaking by submitting 
written views, opinions, recommendations, and data. Comments received, 
including attachments and other supporting materials, are part of the 
public record and subject to public disclosure. Do not include any 
information in your comment or supporting materials that you do not 
wish to be disclosed publicly. You may submit comments on any topic 
related to this DFR.

II. Authority for These Regulations

    The legal authority for this rulemaking is primarily based on Title 
V of the Independent Offices Appropriation Act of 1952 (31 U.S.C. 9701) 
which provides general authority to Federal agencies to establish user 
fees through regulations. HHS/CDC has legal authority to retain 
collected user fees through its annual appropriations bill. In fiscal 
year 2013, this authority is provided through the Continuing 
Appropriations Resolution, 2013, P.L. 112-175, 126 Stat. 1313 (2012). 
Additionally, HHS/CDC has legal authority under section 352 of the 
Public Health Service Act (42 U.S.C. 263). This section states that 
HHS/CDC may prepare any biological product described under section 351 
of the Public Health Service Act (42 U.S.C. 262) for use by other 
Federal departments or agencies, and public or private agencies and 
individuals engaged in work in the field of medicine when such a 
product is not available from establishments licensed by HHS. HHS/CDC 
is also revising the legal authority section of the regulations to cite 
additional legal authority found in section 301(a) of the Public Health 
Service Act (42 U.S.C. 241(a)). This section states that the HHS 
Secretary may make substances and living organisms available to 
individuals and entities for biomedical and behavioral research under 
such terms and conditions (including payment) as the Secretary 
determines appropriate.

III. Why are we doing this rulemaking?

    Under Executive Order 13563 (Improving Regulation and Regulatory 
Review), Federal agencies are required to periodically review existing 
regulation and consider how best to modify rules that may be outmoded, 
ineffective, insufficient, or excessively burdensome. As part of its 
periodic review of its regulations, HHS/CDC has identified this 
regulation as one that requires updating.
    The regulations at 42 CFR 7 ``Distribution of Reference Biological 
Standards and Biological Preparations'' were promulgated in 1987 and 
have not been revised since then. In 1992, the U.S. Congress, as part 
of the Preventive Health Amendments of 1992, recognized CDC's 
leadership role in prevention by formally changing its name to the 
Centers for Disease Control and Prevention. The mailing address for 
HHS/CDC's Financial Management Office changed in the mid-1990s when the 
office moved from the Buckhead location. This update removes that 
address. Finally, this update will now include current contact 
information to obtain information concerning the availability of 
reference biological standards, the fee schedule, and payment 
instructions.
    Thus, through this Direct Final Rule (DFR), HHS/CDC is simply 
updating the regulation to clarify the rule for the public. This DFR 
does not create any additional requirements or burden, nor does it 
affect the current practices of HHS/CDC. This rulemaking does not 
change the method by which fees are calculated.
    HHS/CDC is publishing a DFR because it does not expect to receive 
any significant adverse comments and believes that these updates add 
clarity to the regulation and are non-controversial. If HHS/CDC does 
not receive any significant adverse comments on this DFR within the 
specified comment period, we will publish a document in the Federal 
Register confirming the effective date of this final rule within 30 
days after the comment period on the DFR ends. If HHS/CDC receives any 
timely significant adverse comment, we will withdraw the DFR in part or 
in whole by publishing a notice in the Federal Register within 30 days 
after the comment period ends. A significant adverse comment is one 
that explains: (1) Why the DFR is inappropriate, including challenges 
to the rule's underlying premise or approach; or (2) why the DFR will 
be ineffective or unacceptable without a change. In determining whether 
a comment necessitates withdrawal of the DFR, HHS/CDC will consider 
whether it warrants a substantive response in a notice and comment 
rulemaking process. If we receive significant adverse comment on this 
DFR, we will publish a timely withdrawal in the Federal Register 
informing the public that the amendment in this rule will not take 
effect. If this DFR is withdrawn, we will carefully consider all public 
comments before proceeding with any further rulemaking.

IV. Updates to Part 7

    The regulations found at 42 CFR 7 describe how private entities may 
obtain reference biological standards and biological preparations from 
HHS/CDC and how charges for such standards and preparations are 
determined. In this DFR, HHS/CDC is updating the Authority citation, 
Section 7.1 (Applicability), Section 7.4 (Schedule of Charges), and 
Section 7.5 (Payment Procedures).

Updates to Authority

    The authority citation will be amended to add section 301(a) of the 
Public Health Service Act (42 U.S.C. 241(a)).

Updates to Section 7.1 Applicability

    Section 7.1 will be amended to change the agency's name from 
``Centers for Disease Control'' to its current name, ``Centers for 
Disease Control and Prevention''.

Updates to Section 7.4 Schedule of Charges

    Section 7.4 directs private entities to contact a particular unit 
within HHS/CDC by mail to obtain a current schedule of charges. This 
section will be amended to remove the reference to an organizational 
unit that no longer exists and replace it with current contact 
information to obtain information concerning the availability of 
reference biological standards and a current schedule of charges. Due 
to the changing inventory of the unique biological standards or 
biological preparations available to the public, some of which are 
prepared only upon request, a phone number in addition to a mailing 
address will be provided for

[[Page 43819]]

the public to request a current inventory and fee schedule. This 
rulemaking does not change the method by which fees are calculated.

Updates to Section 7.5 Payment Procedures

    Section 7.5 instructs the public on how to obtain information on 
terms of payment and the current fee schedule. This section will be 
amended to provide current contact information for the public.

V. Alternatives Considered

    Under Executive Order 13563 agencies are asked to consider all 
feasible alternatives to current practice and the rule as proposed. 
HHS/CDC notes that the main impact of this proposed rule is to update 
current definitions and clarify language in the current regulation to 
reflect modern terminology and plain language commonly used by global 
private sector industry and public health partners. The intent of this 
update is to clarify the name of the agency and the mailing address in 
the existing regulation to help the regulated community comply with 
current regulation. HHS/CDC believes that this rulemaking complies with 
the spirit of the Executive Order; updating the agency name and address 
provides good alternatives to the current regulation.

VI. Required Regulatory Analyses

A. Required Regulatory Analyses Under Executive Orders 12866 and 13563

    Under Executive Order 12866 (EO 12866), Regulatory Planning and 
Review (58 FR 51735, October 4, 1993) HHS/CDC is required to determine 
whether this regulatory action would be ``significant'' and therefore 
subject to review by the Office of Management and Budget (OMB) and the 
requirements of the Executive Orders. This order defines ``significant 
regulatory action'' as any regulatory action that is likely to result 
in a rule that may:
    [ssquf] Have an annual effect on the economy of $100 million or 
more or adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or state, local, or tribal governments or 
communities;
    [ssquf] Create a serious inconsistency or otherwise interfere with 
an action taken or planned by another agency;
    [ssquf] Materially alter the budgetary impact of entitlements, 
grants, user fees, or loan programs or the rights and obligations of 
recipients; or,
    [ssquf] Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in EO 
12866.
    Executive Order 13563 (EO 13563), Improving Regulation and 
Regulatory Review, (76 FR 3821, January 21, 2011), updates some of the 
provisions of EO 12866 in order to promote more streamlined regulatory 
actions. This EO charges, in part, that, while protecting ``public 
health, welfare, safety, and our environment'' that regulations must 
also ``promote predictability and reduce uncertainty'' in order to 
promote economic growth. Further, regulations must be written in common 
language and be easy to understand. In the spirit of EO 13563, this DFR 
clarifies the regulation by updating the agency name and mailing 
address.
    HHS/CDC has determined that this DFR is simply an update and 
clarification of the authority citation, agency name, and mailing 
address used in the current regulation. As such, the DFR complies with 
the spirit of EO 13563. Further, HHS/CDC has determined that this DFR 
is not a significant regulatory action as defined in EO 12866 because 
the DFR is administrative and does not change the baseline costs for 
any of the primary stakeholders. The Office of Management and Budget 
(OMB) has not reviewed this rulemaking.

B. Regulatory Flexibility Act

    We have examined the impacts of the rule under the Regulatory 
Flexibility Act (5 U.S.C. 601-612). Unless we certify that the rule is 
not expected to have a significant economic impact on a substantial 
number of small entities, the Regulatory Flexibility Act (RFA), as 
amended by the Small Business Regulatory Enforcement Fairness Act 
(SBREFA), requires agencies to analyze regulatory options that would 
minimize any significant economic impact of a rule on small entities. 
We certify that this rule will not have a significant economic impact 
on a substantial number of small entities within the meaning of the 
RFA.

C. Small Business Regulatory Enforcement Fairness Act of 1996

    This DFR is not a major rule as defined by Sec. 804 of the Small 
Business Regulatory Enforcement Fairness Act of 1996. This rule will 
not result in an annual effect on the economy of $100,000,000 or more; 
a major increase in cost or prices; or significant adverse effects on 
competition, employment, investment, productivity, innovation, or on 
the ability of United States-based companies to compete with foreign-
based companies in domestic and export markets.

D. The Paperwork Reduction Act of 1995

    HHS/CDC has already determined that the Paperwork Reduction Act 
applies to the data collection requirements of 42 CFR Part 7 and has 
obtained approval by OMB to collect information under OMB Control No. 
0920-0591, expiration 07/31/2014. The changes in this rule do not 
impact the data collection and do not require revision to the approval 
from OMB.

E. National Environmental Policy Act (NEPA)

    Pursuant to 48 FR 9374 (list of HHS/CDC program actions that are 
categorically excluded from the NEPA environmental review process), 
HHS/CDC has determined that this action does not qualify for a 
categorical exclusion. In the absence of an applicable categorical 
exclusion, HHS/CDC has determined that provisions amending 42 CFR Part 
7 will not have a significant impact on the human environment. 
Therefore, neither an environmental assessment nor an environmental 
impact statement is required.

F. Civil Justice Reform (Executive Order 12988)

    This rule has been reviewed under Executive Order 12988, Civil 
Justice Reform. Under this rule: (1) All State and local laws and 
regulations that are inconsistent with this rule will be preempted; (2) 
no retroactive effect will be given to this rule; and (3) 
administrative proceedings will not be required before parties may file 
suit in court challenging this rule.

G. Executive Order 13132 (Federalism)

    HHS/CDC has reviewed this rule in accordance with Executive Order 
13132 regarding Federalism, and has determined that it does not have 
``federalism implications.'' The rule does not ``have substantial 
direct effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.''

H. Plain Language Act of 2010

    Under Public Law 111-274 (October 13, 2010), executive Departments 
and Agencies are required to use plain language in documents that 
explain to the public how to comply with a requirement the Federal 
Government administers or enforces. HHS/CDC has attempted to use plain 
language in

[[Page 43820]]

promulgating this rule consistent with the Federal Plain Writing Act 
and requests public comment on this effort.

List of Subjects in 42 CFR 7

    Public health, CDC, Reference biological standards, Biological 
preparations, Schedule of charges

Amended Text

    For the reasons discussed in the preamble, the Department of Health 
and Human Services amends 42 CFR Part 7 as follows:

PART 7--DISTRIBUTION OF REFERENCE BIOLOGICAL STANDARDS AND 
BIOLOGICAL PREPARATIONS

0
1. The authority citation for part 7 is revised to read as follows:

    Authority: Sec. 215, 58 Stat. 690, as amended (42 U.S.C. 216); 
title V of the Independent Offices Appropriations Act of 1952 (31 
U.S.C. 9701); and secs. 301(a) and 352 of the Public Health Service 
Act, as amended (42 U.S.C. 241(a) and 263).
* * * * *

0
2. Revise Sec.  7.1 to read as follows:


Sec.  7.1  Applicability.

    The provisions of this part are applicable to private entities 
requesting from the Centers for Disease Control and Prevention (CDC) 
reference biological Standards and Biological preparations for use in 
their laboratories.

0
3. Revise Sec.  7.4 to read as follows:


Sec.  7.4  Schedule of charges.

    The charges imposed in Sec.  7.2 are based on the amount published 
in CDC's price list of available products. These changes will reflect 
direct costs (such as salaries and equipment), indirect costs (such as 
rent, telephone service, and a proportionate share of management and 
administrative costs), and the cost of particular ingredients. Charges 
may vary over time and between different biological standards or 
biological preparations, depending upon the cost of ingredients and the 
complexity of production. An up-to-date schedule of charges is 
available from the Division of Scientific Resources, Centers for 
Disease Control, 1600 Clifton Road NE., MS C-17, Atlanta, Georgia, 
30333 or 404-639-3466.

0
4. Revise Sec.  7.5 to read as follows:


Sec.  7.5  Payment procedures.

    An up-to-date fee schedule and instructions for terms of payment 
are available from the Division of Scientific Resources, Centers for 
Disease Control and Prevention, 1600 Clifton Road, MS C-17, Atlanta, 
Georgia 30333 or 404-639-3466. Any changes in the fee schedule will be 
published in the Federal Register. The fee must be paid in U.S. dollars 
at the time that the requester requests the biological reference 
standard or biological preparation.

    Dated: July 12, 2013.
Kathleen Sebelius,
Secretary.
[FR Doc. 2013-17543 Filed 7-19-13; 8:45 am]
BILLING CODE 4163-18-P