Revision of the Requirements for Publication of License Revocation, 20583-20585 [E9-10244]
Download as PDF
Federal Register / Vol. 74, No. 85 / Tuesday, May 5, 2009 / Rules and Regulations
‘‘Substances Prohibited From Use in
Animal Food or Feed’’ (referred to
herein as the April 25, 2008, final rule),
that would become effective 1 year after
that publication.’’
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 589
Dated: April 28, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–10138 Filed 5–4–09; 8:45 am]
[Docket No. FDA–2002–N–0031] (formerly
Docket No. 2002N–0273)
RIN 0910–AF46
Substances Prohibited From Use in
Animal Food or Feed; Confirmation of
Effective Date of Final Rule; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION: Final rule; confirmation of
effective date; correction.
VerDate Nov<24>2008
22:59 May 04, 2009
Jkt 217001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
The Food and Drug
Administration (FDA) is correcting a
final rule; confirmation of effective date,
that appeared in the Federal Register of
Friday, April 24, 2009 (74 FR 18626)
(the April 24, 2009, final rule;
confirmation of effective date). That
document had confirmed the effective
date of April 27, 2009, for a final rule
that published in the Federal Register of
April 25, 2008 (73 FR 22720), entitled
‘‘Substances Prohibited From Use in
Animal Food or Feed.’’ In the April 24,
2009, final rule; confirmation of
effective date, the agency also
established a compliance date of
October 26, 2009, in order to allow
additional time for renderers to comply
with the new requirements. The April
24, 2009, final rule; confirmation of
effective date was published with an
inadvertent error in the ‘‘Background’’
section. This document corrects that
error.
DATES: This correction is effective: May
5, 2009.
FOR FURTHER INFORMATION CONTACT:
Joyce A. Strong, Office of Policy,
Planning, and Preparedness (HF–27),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–827–7010.
SUPPLEMENTARY INFORMATION: In FR Doc.
E9–9466, appearing on page 18626 in
the Federal Register of Friday, April 24,
2009, the following correction is made:
On page 18626, in the third column,
under ‘‘I. Background,’’ in the first
paragraph, the first sentence ‘‘In the
Federal Register of April 25, 2008, FDA
published a final rule entitled
‘‘Substances Prohibited From Use in
Animal Food or Feed)’’ (referred to
herein as the April 25, 2008, final rule),
that would become effective 1 year after
the April 27, 2009, date of publication.’’
is corrected to read ‘‘In the Federal
Register of April 25, 2008, FDA
published a final rule entitled
SUMMARY:
BILLING CODE 4160–01–S
21 CFR Part 601
[Docket No. FDA–2009–N–0100]
Revision of the Requirements for
Publication of License Revocation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Direct final rule.
SUMMARY: The Food and Drug
Administration (FDA) is clarifying the
regulatory procedures for notifying the
public about the revocation of a
biologics license to be consistent with
current practices. FDA is amending the
regulations in accordance with the
agency’s direct final rule procedures.
Elsewhere in this issue of the Federal
Register, we are publishing a
companion proposed rule under FDA’s
usual procedures for notice and
comment rulemaking to provide a
procedural framework to finalize the
rule in the event that we receive any
significant adverse comments on the
direct final rule. If we receive any
significant adverse comments that
warrant terminating the direct final rule,
we will consider such comments on the
proposed rule in developing the final
rule.
DATES: This rule is effective September
17, 2009. Submit written or electronic
comments on or before July 20, 2009. If
FDA receives no significant adverse
comments within the specified
comment period, the agency will
publish a document confirming the
effective date of the final rule in the
Federal Register within 30 days after
the comment period on this direct final
rule ends. If timely significant adverse
comments are received, the agency will
publish a document in the Federal
Register withdrawing this direct final
rule.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2009–N–
0100, by any of the following methods:
PO 00000
Frm 00025
Fmt 4700
Sfmt 4700
20583
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
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 email. 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 https://
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 https://
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.
SUPPLEMENTARY INFORMATION:
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.
E:\FR\FM\05MYR1.SGM
05MYR1
20584
Federal Register / Vol. 74, No. 85 / Tuesday, May 5, 2009 / Rules and Regulations
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’’
(§ 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 § 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
reasonable grounds to revoke the license
exist under § 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 Direct Final Rule
FDA is amending § 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 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 § 601.5(b).
This amendment also clarifies that the
phrase ‘‘with statement of the cause
therefor,’’ (§ 601.8) refers to the specific
grounds for revocation enumerated in
§ 601.5(b). The rule, as amended, does
not affect other regulations or
procedures for notification of license
revocation. The 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
VerDate Nov<24>2008
22:59 May 04, 2009
Jkt 217001
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. Rulemaking Action
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
this 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,
FDA is publishing, elsewhere in this
issue of the Federal Register, a
companion proposed rule to amend
§ 601.8. The companion proposed rule
provides a procedural framework within
which the rule may be finalized in the
event that the direct final rule is
withdrawn due to any significant
adverse comments. The comment period
for the direct final rule runs
concurrently with the companion
proposed rule. Any comments received
in response to the companion proposed
rule will 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-andcomment 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 procedure.
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
PO 00000
Frm 00026
Fmt 4700
Sfmt 4700
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-andcomment 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
direct final 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 direct final 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 direct final rule
makes current regulations consistent
with existing FDA practices and
procedures, the agency certifies that this
direct 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
E:\FR\FM\05MYR1.SGM
05MYR1
Federal Register / Vol. 74, No. 85 / Tuesday, May 5, 2009 / Rules and Regulations
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 final rule to result in any 1-year
expenditure that would meet or exceed
this amount.
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:
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 required.
C. Federalism
FDA has analyzed this direct final
rule in accordance with the principles
set forth in Executive Order 13132. FDA
has determined that the direct final 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 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.
PART 601—LICENSING
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).
■
2. Revise § 601.8 to read as follows:
§ 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. E9–10244 Filed 5–4–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
VI. Paperwork Reduction Act of 1995
33 CFR Part 117
This direct final 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.
[Docket No. USCG–2009–0024]
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.
VerDate Nov<24>2008
22:59 May 04, 2009
Jkt 217001
Drawbridge Operation Regulation;
High Street Drawbridge, Alameda, CA
Coast Guard, DHS.
Notice of temporary deviation
from regulations.
AGENCY:
ACTION:
SUMMARY: The Commander, Eleventh
Coast Guard District, has issued a
temporary deviation from the regulation
governing the operation of the High
Street drawbridge across the Oakland
Inner Harbor, mile 6.0, at Alameda, CA.
The deviation is necessary to allow
seismic retrofitting of the bridge. This
deviation allows single leaf operation of
the double leaf, bascule style
drawbridge, during the deviation
period.
DATES: This deviation is effective from
12:01 a.m. on May 1, 2009 until 11:59
p.m. on August 31, 2009.
PO 00000
Frm 00027
Fmt 4700
Sfmt 4700
20585
ADDRESSES: Documents indicated in this
preamble as being available in the
docket are part of the docket USCG–
2009–0024 and are available online by
going to https://www.regulations.gov,
selecting the Advanced Docket Search
option on the right side of the screen,
inserting USCG–2009–0024 in the
Docket ID box, pressing Enter, and then
clicking on the item in the Docket ID
column. This material is also available
for inspection or copying at the Docket
Management Facility (M–30), U.S.
Department of Transportation, West
Building Ground Floor, Room W12–140,
1200 New Jersey Avenue, SE.,
Washington, DC 20590, between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this rule call
David H. Sulouff, Chief, Bridge Section,
Eleventh Coast Guard District,
telephone (510) 437–3516. If you have
questions on viewing the docket, call
Renee Wright, Program Manager, Docket
Operations, telephone (202) 366–9826.
SUPPLEMENTARY INFORMATION: The
County of Alameda requested a
temporary change to the operation of the
High Street drawbridge across the
Oakland Inner Harbor, mile 6.0, at
Alameda, CA. The High Street
drawbridge navigation span provides a
horizontal clearance of 244 feet between
pier fenders. During single leaf
operation, horizontal clearance is
reduced to approximately 100 feet. The
drawbridge provides a vertical clearance
of 16 feet above Mean High Water in the
closed-to-navigation position and
unlimited vertical clearance in the
open-to-navigation position. As required
by 33 CFR 117.181, the draw shall open
on signal; except that, from 8 a.m. to 9
a.m. and 4:30 p.m. to 6:30 p.m. Monday
through Friday except Federal holidays,
the draw need not be opened for the
passage of vessels. However, the draw
shall open during the above closed
periods for vessels which must, for
reasons of safety, move on a tide or
slack water, if at least two hours notice
is given. The waterway is navigated by
commercial, recreational, emergency
and law enforcement vessels.
Between the hours of 7 a.m. and 9
p.m. Monday through Thursday, and
between the hours of 7 a.m. and 3:30
p.m. on Friday, the drawspan may be
operated, one leaf at a time, while the
opposite leaf is seismically retrofitted.
The drawbridge will be operated in the
normal double leaf operation mode at
night and on weekends, when work is
not actually being performed on the
bridge. The starting and ending dates for
the project are from 12:01 a.m. on May
E:\FR\FM\05MYR1.SGM
05MYR1
Agencies
[Federal Register Volume 74, Number 85 (Tuesday, May 5, 2009)]
[Rules and Regulations]
[Pages 20583-20585]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-10244]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 601
[Docket No. FDA-2009-N-0100]
Revision of the Requirements for Publication of License
Revocation
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is clarifying the
regulatory procedures for notifying the public about the revocation of
a biologics license to be consistent with current practices. FDA is
amending the regulations in accordance with the agency's direct final
rule procedures. Elsewhere in this issue of the Federal Register, we
are publishing a companion proposed rule under FDA's usual procedures
for notice and comment rulemaking to provide a procedural framework to
finalize the rule in the event that we receive any significant adverse
comments on the direct final rule. If we receive any significant
adverse comments that warrant terminating the direct final rule, we
will consider such comments on the proposed rule in developing the
final rule.
DATES: This rule is effective September 17, 2009. Submit written or
electronic comments on or before July 20, 2009. If FDA receives no
significant adverse comments within the specified comment period, the
agency will publish a document confirming the effective date of the
final rule in the Federal Register within 30 days after the comment
period on this direct final rule ends. If timely significant adverse
comments are received, the agency will publish a document in the
Federal Register withdrawing this direct final rule.
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: https://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 https://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 https://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.
SUPPLEMENTARY INFORMATION:
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.
[[Page 20584]]
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 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 Direct Final Rule
FDA is amending 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 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 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 rule, as amended, does not affect other regulations or procedures
for notification of license revocation. The 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. Rulemaking Action
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 this 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,
FDA is publishing, elsewhere in this issue of the Federal Register, a
companion proposed rule to amend Sec. 601.8. The companion proposed
rule provides a procedural framework within which the rule may be
finalized in the event that the direct final rule is withdrawn due to
any significant adverse comments. The comment period for the direct
final rule runs concurrently with the companion proposed rule. Any
comments received in response to the companion proposed rule will 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
procedure.
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 direct final 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 direct final 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 direct final rule makes current
regulations consistent with existing FDA practices and procedures, the
agency certifies that this direct 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
[[Page 20585]]
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 final rule to result in any 1-year
expenditure that would meet or exceed this amount.
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
required.
C. Federalism
FDA has analyzed this direct final rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the direct final 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 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.
VI. Paperwork Reduction Act of 1995
This direct final 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.
0
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:
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).
0
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. E9-10244 Filed 5-4-09; 8:45 am]
BILLING CODE 4160-01-S