[Federal Register Volume 61, Number 149 (Thursday, August 1, 1996)]
[Rules and Regulations]
[Pages 40153-40155]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19604]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 601, 620, 630, 640, 650, 660, and 680
[Docket No. 95N-310B]
Revocation of Certain Regulations; Biological Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule
to remove certain biologics regulations that are obsolete or no longer
necessary to achieve public health goals. These regulations were
identified for removal as the result of a page-by-page review of the
agency's regulations. This regulatory review is in response to the
Administration's ``Reinventing Government'' initiative which seeks to
streamline government to ease the burden on regulated industry and
consumers.
EFFECTIVE DATE: August 12, 1996.
FOR FURTHER INFORMATION CONTACT:
Regarding general information on FDA's ``reinventing initiative'':
Lisa M. Helmanis, Office of Policy (HF-26), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-3480.
Regarding biologics regulations: Annette A. Ragosta, Center for
Biologics Evaluation and Research (HFM-630), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-594-3074.
SUPPLEMENTARY INFORMATION:
I. Background
On March 4, 1995, President Clinton announced plans for the reform
of the Federal regulatory system as part of the Administration's
``Reinventing Government'' initiative. In his March 4 directive, the
President ordered all Federal agencies to conduct a page-by-page review
of their regulations and to ``eliminate or revise those that are
outdated or otherwise in need of reform.'' In the Federal Register of
October 13, 1995 (60 FR 53480), FDA issued a notice of proposed
rulemaking in which FDA proposed to remove a number of outdated or
unnecessary regulations in parts 100 through 801 (21 CFR parts 100
through 801). The regulations proposed for removal apply to a variety
of products regulated by FDA, including foods, drugs, veterinary drugs,
biological products, and devices. Interested persons were requested
when submitting comments to identify the FDA Center responsible for the
regulation of the product to which the comments applied. In order to
expedite matters, the final rules resulting from the line-by-line
review are being issued separately by FDA Centers. FDA is issuing this
final rule, which eliminates
[[Page 40154]]
certain regulations affecting biological products in parts 600 through
680.
II. Comments
FDA received two comments on the proposed rule that related to the
biologics regulations. One comment was general in nature and urged
Congress to include FDA reform as a top priority in 1996.
Congress is currently considering legislation that would affect FDA
programs and procedures. FDA has testified at congressional hearings on
the pending bills. The agency does not believe it would be appropriate
to comment on the ongoing legislative initiatives in this rulemaking.
The agency agrees with the comment that regulatory programs and the
regulations that implement them should be reviewed and revised or
reformed where appropriate. FDA is currently reviewing other biologics
regulations, the potential removal or revision of which involves issues
of greater regulatory complexity and, based on this review, will remove
or significantly revise these regulations at a later date. In addition,
a number of changes to the regulations and policies affecting
biological products are already underway. (See for example, ``Interim
Definition and Elimination of Lot-by-Lot Release for Well-Characterized
Therapeutic Recombinant DNA-Derived and Monoclonal Antibody
Biotechnology Products'' (60 FR 63048, December 8, 1995); ``Well-
Characterized Biotechnology Products; Elimination of Establishment
License Application'' (61 FR 2733, January 29, 1996); ``Changes to an
Approved Application'' (61 FR 2739); ``Draft Guidance; Changes to an
Approved Application for Well-Characterized Therapeutic Recombinant
DNA-Derived and Monoclonal Antibody Biotechnology Products;
Availability'' (61 FR 2748); ``Changes to an Approved Application;
Draft Guidance; Availability'' (61 FR 2749).) This final rule,
``Revocation of Certain Regulations; Biological Products,'' is one part
of the agency's efforts to create a more efficient and responsive
regulatory system.
The other comment received was supportive of the proposed rule and
stated that it was a good first step in reducing regulatory burden. The
comment suggested the incorporation of the United States Pharmacopeia
(USP) monograph system based on the Center for Drug Evaluation and
Research model into the Center for Biologics Evaluation and Research's
regulatory reform process.
The agency does not agree with this suggestion because biologics,
for which FDA is removing additional standards from the regulations,
are complex and diverse entities. Monographs for many types of
biological products could become quickly outdated in the rapidly
evolving field of biotechnology, as did the Additional Standards in
parts 620, 630, 640, 650, 660, and 680, which this final rule is
removing. Use of monographs would allow for less flexibility in the
development of product specifications for complex biologicals.
III. Effective Date
As provided under 5 U.S.C. 553(d) and Sec. 10.40(c) (21 CFR
10.40(c)), the effective date of a final rule may not be less than 30
days after the date of publication, except for, among other things, ``a
regulation that grants an exemption or relieves a restriction''
(Sec. 10.40(c)(4)(i)). The final rule is effective August 12, 1996.
IV. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs 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 final rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the final
rule is not a significant regulatory action as defined by the Executive
Order and so is not subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the proposed removals have no compliance
costs and do not result in any new requirements, the agency certifies
that the final rule will not have a significant economic impact on a
substantial number of small entities. Therefore, under the Regulatory
Flexibility Act, no further analysis is required.
V. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(8) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
List of Subjects
21 CFR Part 601
Administrative practice and procedure, Biologics, Confidential
business information.
21 CFR Part 620
Biologics, Labeling, Reporting and recordkeeping requirements.
21 CFR Part 630
Biologics, Labeling.
21 CFR Part 640
Blood, Labeling, Reporting and recordkeeping requirements.
21 CFR Part 650
Biologics.
21 CFR Part 660
Biologics, Labeling, Reporting and recordkeeping requirements.
21 CFR Part 680
Biologics, Blood, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and the
Public Health Service Act and under authority delegated to the
Commissioner of Food and Drugs, 21 CFR parts 601, 620, 630, 640, 650,
660, and 680 are amended as follows:
PART 601--LICENSING
1. The authority citation for 21 CFR part 601 continues to read as
follows:
Authority: Secs. 201, 501, 502, 503, 505, 510, 513-516, 518-520,
701, 704, 721, 801 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 374,
379e, 381); secs. 215, 301, 351, 352 of the Public Health Service
Act (42 U.S.C. 216, 241, 262, 263); secs. 2-12 of the Fair Packaging
and Labeling Act (15 U.S.C. 1451-1461).
Sec. 601.30 [Removed]
2. Section 601.30 Licenses required; products for controlled
investigation only is removed.
Sec. 601.31 [Removed]
3. Section 601.31 Procedure is removed.
Sec. 601.32 [Removed]
4. Section 601.32 Form of license is removed.
PART 620--ADDITIONAL STANDARDS FOR BACTERIAL PRODUCTS-
Part 620 [Removed]
5. Part 620 is removed.
[[Page 40155]]
PART 630--ADDITIONAL STANDARDS FOR VIRAL VACCINES
Part 630 [Removed]
6. Part 630 is removed.
PART 640--ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
7. The authority citation for 21 CFR part 640 continues to read as
follows:
Authority: Secs. 201, 501, 502, 503, 505, 510, 701 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353,
355, 360, 371); secs. 215, 351, 352, 353, 361 of the Public Health
Service Act (42 U.S.C. 216, 262, 263, 263a, 264).
Subpart K [Removed and Reserved]
8. Subpart K, consisting of Secs. 640.110 through 640.114, is
removed and reserved.
PART 650--ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR DERMAL
TESTS
Part 650 [Removed]
9. Part 650 is removed.
PART 660--ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR
LABORATORY TESTS
10. The authority citation for 21 CFR part 660 continues to read as
follows:
Authority: Secs. 201, 501, 502, 503, 505, 510, 701 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353,
355, 360, 371); secs. 215, 351, 352, 353, 361 of the Public Health
Service Act (42 U.S.C. 216, 262, 263, 263a, 264).
Subpart K [Removed]
11. Subpart K, consisting of Secs. 660.100 through 660.105, is
removed.
PART 680--ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS
12. The authority citation for 21 CFR part 680 continues to read as
follows:
Authority: Secs. 201, 501, 502, 503, 505, 510, 701 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353,
355, 360, 371); secs. 215, 351, 352, 353, 361 of the Public Health
Service Act (42 U.S.C. 216, 262, 263, 263a, 264).
13. The heading for Subpart A--Allergenic Products is removed.
Subpart B [Removed]
14. Subpart B, consisting of Secs. 680.10 through 680.16, is
removed.
Subpart C [Removed]
15. Subpart C, consisting of Secs. 680.20 through 680.26, is
removed.
Dated: July 19, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-19604 Filed 7-31-96; 8:45 am]
BILLING CODE 4160-01-F
