[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]


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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.

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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outdated or otherwise in need of reform.''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rulemaking in which FDA proposed to remove a number of outdated or 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.

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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