[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Rules and Regulations]
[Pages 7445-7446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02884]
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Rules and Regulations
Federal Register
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Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 /
Rules and Regulations
[[Page 7445]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 601
[Docket No. FDA-2015-N-2103]
Removal of Review and Reclassification Procedures for Biological
Products Licensed Prior to July 1, 1972
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
removing two regulations that prescribe procedures for FDA's review and
classification of biological products licensed before July 1, 1972. FDA
is taking this action because the two regulations are obsolete and no
longer necessary in light of other statutory and regulatory authorities
established since 1972, which allow FDA to evaluate and monitor the
safety and effectiveness of all biological products. In addition, other
statutory and regulatory authorities authorize FDA to revoke a license
for biological products because they are not safe and effective, or are
misbranded. FDA is taking this action as part of its retrospective
review of its regulations to promote improvement and innovation.
DATES: This rule is effective March 14, 2016.
ADDRESSES: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number found in brackets in the heading of this final rule into
the ``Search'' box and follow the prompts, and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1062, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Jessica T. Walker, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Purpose of the Final Rule
FDA is removing two regulations that prescribe procedures for FDA's
review and classification of biological products licensed before July
1, 1972, because the two regulations are obsolete and no longer
necessary in light of other statutory and regulatory authorities
established since 1972. These other statutory and regulatory
authorities allow FDA to evaluate and monitor the safety and
effectiveness of all biological products and authorize FDA to revoke a
license for products because they are not safe and effective, or are
misbranded.
B. Summary of the Major Provisions of the Final Rule
The final rule removes Sec. Sec. 601.25 and 601.26 (21 CFR 601.25
and 601.26), which prescribe procedures for FDA's review and
classification of biological products licensed before July 1, 1972.
C. Legal Authority
FDA is taking this action under the biological products provisions
of the Public Health Service Act (the PHS Act), and the drugs and
general administrative provisions of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act).
D. Costs and Benefits
Because this final rule would not impose any additional regulatory
burdens, this regulation is not anticipated to result in any compliance
costs and the economic impact is expected to be minimal.
II. Background
A. History of the Rulemaking
In the Federal Register of July 2, 2015 (80 FR 38145), FDA proposed
to remove regulations that prescribe procedures for FDA's review and
classification of biological products licensed before July 1, 1972. As
discussed in the preamble to the proposed rule, these regulations were
originally issued after the Director of the National Institutes of
Health (NIH) announced in the Federal Register on March 15, 1972, that
the Division of Biologics Standards, NIH, would review the
effectiveness of all licensed biologicals (37 FR 5404). In the Federal
Register of June 29, 1972 (37 FR 12865), FDA announced the transfer of
regulatory authority over biological products from the Division of
Biologics Standards, NIH, to FDA. After obtaining regulatory authority
over biological products, the Commissioner of FDA proposed procedures
for reviewing the safety, effectiveness, and labeling of all biological
products licensed at the time of the transfer on July 1, 1972 (37 FR
16679, August 18, 1972). The procedures for review of biological
products licensed before July 1, 1972, were codified in 21 CFR 273.245
(38 FR 4319 at 4321, February 13, 1973) and later redesignated to Sec.
601.25 (38 FR 32048, November 20, 1973). The procedures for review of
biological products licensed before July 1, 1972, were supplemented by
procedures codified in Sec. 601.26 (47 FR 44062, October 5, 1982).
B. Current Methods for Ensuring the Safety and Effectiveness of
Biological Products
Since establishing the procedures under Sec. Sec. 601.25 and
601.26, FDA developed new regulations to assess and ensure the safety
and efficacy of biological products. FDA issued the Current Good
Manufacturing Practice (cGMP) regulations, which contain the minimum
cGMP for preparation of drug products, including biological products.
The cGMP regulations help FDA ensure that such products meet the
requirements for product safety, effectiveness, and labeling. FDA also
helps ensure the safety and effectiveness of biological products
through application of other regulations, such as the reporting of
biological product deviations by licensed manufacturers (see 21 CFR
600.14), postmarketing reporting of adverse experiences (21 CFR
600.80), and labeling regulations (for example, 21 CFR part 201).
Biological products that do not meet the requirements under these
regulations are subject to license revocation under 21 CFR 601.5, which
allows FDA to revoke any biologics license for a product that fails to
meet applicable standards and fails to comply with
[[Page 7446]]
regulations designed to help ensure the safety, purity, and potency of
the licensed product, and that the product is not misbranded.
In addition, FDA continues to help ensure the safety and
effectiveness of licensed biological products through the development
and application of additional standards and mechanisms. These
mechanisms assist FDA in evaluating and monitoring the safety and
effectiveness of biological products.
C. Summary of Comments to the Proposed Rule
FDA did not receive any comments on the proposed rule.
D. General Overview of the Final Rule
The final rule removes Sec. Sec. 601.25 and 601.26 of the
regulations, which prescribe procedures for FDA's review and
classification of biological products licensed before July 1, 1972. FDA
is taking this action because these regulations are obsolete and no
longer necessary in light of other statutory and regulatory authorities
established since 1972, which allow FDA to evaluate and monitor the
safety and effectiveness of all biological products.
III. Legal Authority
FDA is issuing this regulation under the biological products
provisions of the PHS Act (42 U.S.C. 262 and 264) and the drugs and
general administrative provisions of the FD&C Act (sections 201, 301,
501, 502, 503, 505, 510, 701, and 704 (21 U.S.C. 321, 331, 351, 352,
353, 355, 360, 371, and 374)). Under these provisions of the PHS Act
and the FD&C Act, we have the authority to issue and enforce
regulations designed to ensure that biological products are safe, pure,
and potent; and to prevent the introduction, transmission, and spread
of communicable disease.
IV. Economic Analysis of Impacts
We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). We believe that this final rule is not a significant
regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this final rule removes regulations that are
obsolete and no longer necessary in light of other current statutory
and regulatory authorities, FDA certifies that the final rule will not
have a significant economic impact on a substantial number of small
entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $144
million, using the most current (2014) Implicit Price Deflator for the
Gross Domestic Product. This final rule would not result in any 1-year
expenditure that would meet or exceed this amount.
V. Analysis of Environmental Impact
We have determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
adverse effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
VI. Paperwork Reduction Act of 1995
This final rule contains no collection of information. Therefore,
clearance by OMB under the Paperwork Reduction Act of 1995 is not
required.
VII. Federalism
We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that would 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. Accordingly, the Agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.
List of Subjects in 21 CFR Part 601
Administrative practice and procedure, Biologics, Confidential
business information.
Therefore, under the Federal Food, Drug, and Cosmetic Act, the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, 21 CFR part 601 is amended as follows:
PART 601--LICENSING
0
1. The authority citation for 21 CFR part 601 continues to read as
follows:
Authority: 15 U.S.C. 1451-1561; 21 U.S.C. 321, 351, 352, 353,
355, 356b, 360, 360c-360f, 360h-360j, 371, 374, 379e, 381; 42 U.S.C.
216, 241, 262, 263, 264; sec 122, Pub. L. 105-115, 111 Stat. 2322
(21 U.S.C. 355 note).
Sec. 601.25 [Removed]
0
2. Remove Sec. 601.25.
Sec. 601.26 [Removed]
0
3. Remove Sec. 601.26.
Dated: February 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02884 Filed 2-11-16; 8:45 am]
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