[Federal Register Volume 74, Number 85 (Tuesday, May 5, 2009)]
[Proposed Rules]
[Pages 20663-20665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-10243]



Food and Drug Administration

21 CFR Part 601

[Docket No. FDA-2009-N-0100]

Revision of the Requirements for Publication of License 
Revocation; Companion Document to Direct Final Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.


SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
the biologics regulations to clarify the regulatory procedures for 
notifying the public about the revocation of a biologics license to be 
consistent with current practices. This proposed rule is a companion 
document to the direct final rule published elsewhere in this issue of 
the Federal Register.

DATES: Submit written or electronic comments on or before July 20, 
2009. If FDA receives any significant adverse comments, the agency will 
publish a document withdrawing the direct final rule within 30 days 
after the comment period ends. FDA will then proceed to respond to 
comments under this proposed rule using the usual notice and comment 

ADDRESSES: You may submit comments, identified by Docket No. FDA-2009-
N-0100, 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:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal, as described previously, in the ADDRESSES portion 
of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name 
and docket number 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 ``Request for 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, 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 (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.


I. Background

    In the Federal Register of January 25, 1977 (42 FR 4680), FDA 
issued a final rule revising, among other things, the procedures under 
part 601 (21 CFR part 601) for issuing, revoking, and suspending 
biologics licenses; and publishing license revocations. FDA revised 
these procedures in order to simplify and codify existing practices, 
establish new requirements where appropriate, and ensure that practices 
and procedures would be consistently applied throughout the agency.
    A provision under the January 25, 1977, final rule provided that a 
``Notice of revocation of a license, with statement of the cause 
therefor, shall be issued by the Commissioner and published in the 
Federal Register'' (Sec.  601.8). FDA interprets this requirement to 
apply only to a license which the Commissioner of Food and Drugs (the 
Commissioner) has found grounds to revoke under Sec.  601.5(b). FDA has 
not routinely published, in the Federal Register, a notice of 
revocation of a biologics license resulting from a manufacturer's 
voluntary request for revocation for reasons unrelated to a finding by 
the Commissioner that

[[Page 20664]]

reasonable grounds to revoke the license exist under Sec.  601.5(b). 
Examples of situations in which a manufacturer might voluntarily 
request that a license be revoked include economic loss, change in 
product marketing strategy, lack of public need, corporate 
reorganization, or the emergence of innovative replacement products. 
FDA does not consider the revocation of licenses in such circumstances 
to require publication in the Federal Register. However, FDA may 
publish a notice of revocation for licenses revoked at the voluntary 
request of a manufacturer in situations where such notice is in the 
interest of public health.

II. Highlights of the Proposed Rule

    FDA is proposing to amend Sec.  601.8 to read: ``The Commissioner, 
following revocation of a biologics license under 21 CFR 601.5(b), will 
publish a notice in the Federal Register with a statement of the 
specific grounds for the revocation.''
    This proposed amendment revises the existing regulation to clarify 
that FDA will publish a notice of license revocation in cases where the 
Commissioner has made a finding that reasonable grounds for revocation 
exist under Sec.  601.5(b). This proposed amendment also clarifies that 
the phrase ``with statement of the cause therefor,'' (Sec.  601.8) 
refers to the specific grounds for revocation enumerated in Sec.  
601.5(b). The proposed rule does not affect other regulations or 
procedures for notification of license revocation. The proposed rule 
does not alter existing FDA practices for publishing notices of 
voluntary withdrawal, including notices of voluntary withdrawal of new 
drug applications.

III. Legal Authority

    FDA is issuing this regulation under the biological products 
provisions of the Public Health Service Act (42 U.S.C. 262 and 264) and 
the drugs and general administrative provisions of the Federal Food, 
Drug, and Cosmetic 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 Public Health Service Act and the 
Federal Food, Drug, and Cosmetic Act, we have the authority to issue 
and enforce regulations designed to ensure that biological products are 
safe, pure, and potent; and prevent the introduction, transmission, and 
spread of communicable disease.

IV. Companion Document to Direct Final Rulemaking

    In the Federal Register of November 21, 1997 (62 FR 62466), FDA 
described the agency's procedures for when and how we will employ 
direct final rulemaking. We have determined that the rule is 
appropriate for direct final rulemaking because it includes only 
noncontroversial amendments, and we anticipate no significant adverse 
comments. Consistent with our procedures on direct final rulemaking, 
this proposed rule is a companion to the direct final rule published 
elsewhere in this issue of the Federal Register. This companion 
proposed rule provides the procedural framework to finalize the rule in 
the event that the direct final rule receives any significant adverse 
comment and is withdrawn. The comment period for this companion 
proposed rule runs concurrently with the comment period for the direct 
final rule. Any comments received in response to this companion 
proposed rule will also be considered as comments regarding the direct 
final rule.
    A significant adverse comment is defined as a comment that explains 
why the rule would be inappropriate, including challenges to the rule's 
underlying premise or approach, or would be ineffective or unacceptable 
without a change. In determining whether an adverse comment is 
significant and warrants terminating a direct final rulemaking, we will 
consider whether the comment raises an issue serious enough to warrant 
a substantive response in a notice-and-comment process in accordance 
with section 553 of the Administrative Procedure Act (APA) (5 U.S.C. 
553). Comments that are frivolous, insubstantial, or outside the scope 
of the rule will not be considered significant or adverse under this 
    A comment recommending a regulation change in addition to that in 
this rule will not be considered a significant adverse comment unless 
the comment states why the rule would be ineffective without the 
additional change. In addition, if a significant adverse comment 
applies to an amendment, paragraph, or section of this rule that can be 
severed from the remainder of the rule, we may adopt as final those 
provisions of the rule that are not the subject of a significant 
adverse comment.
    If any significant adverse comments are received during the comment 
period, FDA will publish, before the effective date of the direct final 
rule, a document withdrawing the direct final rule. If we withdraw the 
direct final rule, any comments received will be applied to the 
companion proposed rule and will be considered in developing a final 
rule using the usual notice-and-comment procedures under the APA (5 
U.S.C. 552a et seq).
    If FDA receives no significant adverse comments during the 
specified comment period, FDA intends to publish a document confirming 
the effective date within 30 days after the comment period ends. 
Additional information about direct rulemaking procedures is set forth 
in a guidance published in the Federal Register of November 21, 1997 
(62 FR 62466).

V. Analysis of Impacts

A. Review Under Executive Order 12866, the Regulatory Flexibility Act, 
and the Unfunded Mandates Reform Act of 1995

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and 
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). 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 proposed rule is not a significant regulatory action 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 rule makes current regulations 
consistent with existing FDA practices and procedures, the agency 
proposed 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 $130 million, using the most current (2007) 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 20665]]

B. Environmental Impact

    The agency has determined under 21 CFR 25.31(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 

C. 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 does not contain policies that 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 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 

VI. Paperwork Reduction Act of 1995

    This proposed rule contains no collections of information. 
Therefore, clearance by the Office of Management and Budget under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required.

VII. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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.

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 and the 
Public Health Service Act, and under authority delegated to the 
Commissioner of Food and Drugs, 21 CFR part 601 is amended as follows:


    1. The authority citation for 21 CFR part 601 continues to read as 

    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).
    2. Revise Sec.  601.8 to read as follows:

Sec.  601.8  Publication of revocation.

    The Commissioner, following revocation of a biologics license under 
21 CFR 601.5(b), will publish a notice in the Federal Register with a 
statement of the specific grounds for the revocation.

    Dated: March 25, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-10243 Filed 5-4-09; 8:45 am]