[Federal Register Volume 80, Number 127 (Thursday, July 2, 2015)]
[Proposed Rules]
[Pages 38145-38147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16367]


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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: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) proposes to remove 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 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: Submit either written or electronic comments on the proposed 
rule by September 30, 2015.

ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No. 
FDA-2015-N-2103 for this rulemaking. All comments received may be 
posted without change to http://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number(s), found in brackets in the heading of this document, 
into the ``Search'' box and follow the prompts and/or go to the 
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852.

FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr., Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301,

[[Page 38146]]

Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

Executive Summary

Purpose of the Proposed Rule

    FDA proposes to remove 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.

Statement of 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).

Summary of the Major Provisions of the Proposed Rule

    The proposed 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.

Costs and Benefits

    Because this proposed 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.

I. Background

    In the Federal Register of March 15, 1972 (37 FR 5404), the 
Director of the National Institutes of Health (NIH) announced that the 
Division of Biologics Standards, NIH would review the effectiveness of 
all licensed biologicals. In the Federal Register of June 29, 1972 (37 
FR 12865), FDA announced the transfer of regulatory authority of 
biological products from the Division of Biologics Standards, NIH to 
FDA. After obtaining regulatory authority of 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, including biological products licensed before 
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).

II. Current Methods for Ensuring the Safety and Effectiveness of 
Biological Products

    Since providing the procedures under Sec. Sec.  601.25 and 601.26, 
FDA established many new regulations to assess and ensure the safety 
and efficacy of biological products. FDA established the Current Good 
Manufacturing Practice (cGMP) regulations, which contains the minimum 
current good manufacturing practice 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 ensures 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 Sec.  601.5, which allows FDA to revoke any biologics license for 
a product that fails to meet applicable standards and comply with 
regulations designed to ensure the safety, purity, and potency of the 
licensed product, and that the product is not misbranded.
    In addition, FDA continues to 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.

III. Description of the Proposed Rule

    The proposed 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 allows FDA to evaluate and monitor the 
safety and effectiveness of all biological products.

IV. 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.

V. Analysis of Impacts

    FDA has examined the impacts of the proposed 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). The Agency believes that this proposed 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 the rule proposes to remove regulations that 
are obsolete and no longer necessary in light of other current 
statutory and regulatory authorities, the Agency proposes to certify 
that the final rule will not have a significant economic impact on a 
substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``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. FDA does not expect this 
proposed rule to result in any 1-year expenditure that would meet or 
exceed this amount.

[[Page 38147]]

VI. Environmental Impact

    The Agency has 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.

VII. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed rule, if finalized, would 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 tentatively concludes that the proposed 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.

VIII. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
collection of information. Therefore, clearance by OMB under the 
Paperwork Reduction Act of 1995 is not required.

IX. 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://www.regulations.gov.

List of Subjects in 21 CFR Part 601

    Administrative practice and procedure, Biologics, Confidential 
business information.

    Therefore, under the FD&C Act, the PHS Act, and under authority 
delegated to the Commissioner of Food and Drugs, it is proposed that 21 
CFR part 601 be 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: June 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16367 Filed 7-1-15; 8:45 am]
BILLING CODE 4164-01-P