Guidance for Industry and Investigators on Enforcement of Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies; Availability, 32863-32864 [2011-13950]
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erowe on DSK5CLS3C1PROD with RULES
Federal Register / Vol. 76, No. 109 / Tuesday, June 7, 2011 / Rules and Regulations
(17) Indianapolis-AndersonColumbus, IN—consisting of the
Indianapolis-Anderson-Columbus, IN
CSA, plus Grant County, IN;
(18) Los Angeles-Long BeachRiverside, CA—consisting of the Los
Angeles-Long Beach-Riverside, CA CSA,
plus the Santa Barbara-Santa MariaGoleta, CA MSA and all of Edwards Air
Force Base, CA;
(19) Miami-Fort Lauderdale-Pompano
Beach, FL—consisting of the Miami-Fort
Lauderdale-Pompano Beach, FL MSA,
plus Monroe County, FL;
(20) Milwaukee-Racine-Waukesha,
WI—consisting of the MilwaukeeRacine-Waukesha, WI CSA;
(21) Minneapolis-St. Paul-St. Cloud,
MN-WI—consisting of the MinneapolisSt. Paul-St. Cloud, MN-WI CSA;
(22) New York-Newark-Bridgeport,
NY-NJ-CT-PA—consisting of the New
York-Newark-Bridgeport, NY-NJ-CT-PA
CSA, plus Monroe County, PA, Warren
County, NJ, and all of Joint Base
McGuire-Dix-Lakehurst;
(23) Philadelphia-Camden-Vineland,
PA-NJ-DE-MD—consisting of the
Philadelphia-Camden-Vineland, PA-NJDE-MD CSA excluding Joint Base
McGuire-Dix-Lakehurst, plus Kent
County, DE, Atlantic County, NJ, and
Cape May County, NJ;
(24) Phoenix-Mesa-Scottsdale, AZ—
consisting of the Phoenix-MesaScottsdale, AZ MSA;
(25) Pittsburgh-New Castle, PA—
consisting of the Pittsburgh-New Castle,
PA CSA;
(26) Portland-Vancouver-Hillsboro,
OR-WA—consisting of the PortlandVancouver-Hillsboro, OR-WA MSA,
plus Marion County, OR, and Polk
County, OR;
(27) Raleigh-Durham-Cary, NC—
consisting of the Raleigh-Durham-Cary,
NC CSA, plus the Fayetteville, NC MSA,
the Goldsboro, NC MSA, and the
Federal Correctional Complex Butner,
NC;
(28) Richmond, VA—consisting of the
Richmond, VA MSA;
(29) Sacramento—Arden-Arcade—
Yuba City, CA-NV—consisting of the
Sacramento—Arden-Arcade—Yuba
City, CA-NV CSA, plus Carson City, NV;
(30) San Diego-Carlsbad-San Marcos,
CA—consisting of the San DiegoCarlsbad-San Marcos, CA MSA;
(31) San Jose-San Francisco-Oakland,
CA—consisting of the San Jose-San
Francisco-Oakland, CA CSA, plus the
Salinas, CA MSA and San Joaquin
County, CA;
(32) Seattle-Tacoma-Olympia, WA—
consisting of the Seattle-TacomaOlympia, WA CSA, plus Whatcom
County, WA;
(33) Washington-Baltimore-Northern
Virginia, DC-MD-VA-WV-PA—
VerDate Mar<15>2010
15:11 Jun 06, 2011
Jkt 223001
consisting of the Washington-BaltimoreNorthern Virginia, DC-MD-VA-WV CSA,
plus the Hagerstown-Martinsburg, MDWV MSA, the York-Hanover-Gettysburg,
PA CSA, and King George County, VA;
and
(34) Rest of U.S.—consisting of those
portions of the United States and its
territories and possessions as listed in 5
CFR 591.205 not located within another
locality pay area.
■ 4. In § 531.606—
■ a. Revise paragraph (b)(1);
■ b. Redesignate paragraph (b)(2) and
(b)(3) as (b)(3) and (b)(4), respectively;
■ c. Add a new paragraph (b)(2); and
■ d. Revise newly designated paragraph
(b)(4).
The revisions and addition read as
follows:
531.606
Maximum limits on locality rates.
(a) * * *
(b)(1) A locality rate for an employee
in a category of positions described in
5 U.S.C. 5304(h)(1)(A) and 5304(h)(1)(B)
may not exceed the rate for level III of
the Executive Schedule.
(2) A locality rate for an employee in
a category of positions described in 5
U.S.C. 5304(h)(1)(C) may not exceed—
(i) The rate for level III of the
Executive Schedule, when the positions
are not covered by an appraisal system
certified under 5 U.S.C. 5307(d); or
(ii) The rate for level II of the
Executive Schedule, when the positions
are covered by an appraisal system
certified under 5 U.S.C. 5307(d).
*
*
*
*
*
(4) If initial application of paragraph
(b)(3) of this section otherwise would
reduce an employee’s existing locality
rate, the employee’s locality rate is
capped at the higher of—
(i) The amount of the employee’s
locality rate on the day before paragraph
(b)(3) of this section was initially
applied; or
(ii) The rate for level IV of the
Executive Schedule.
*
*
*
*
*
[FR Doc. 2011–13993 Filed 6–6–11; 8:45 am]
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32863
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 312 and 320
[Docket No. FDA–2010–D–0482]
Guidance for Industry and
Investigators on Enforcement of Safety
Reporting Requirements for
Investigational New Drug Applications
and Bioavailability/Bioequivalence
Studies; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of guidance.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
and investigators entitled ‘‘Enforcement
of Safety Reporting Requirements for
INDs and BA/BE Studies.’’ This
guidance is intended to inform sponsors
and investigators of FDA’s intent to
exercise enforcement discretion
regarding the reporting requirements in
the final rule, ‘‘Investigational New Drug
Safety Reporting Requirements for
Human Drug and Biological Products
and Safety Reporting Requirements for
Bioavailability and Bioequivalence
Studies in Humans’’ (75 FR 59935,
September 29, 2010), until September
28, 2011. This action is being taken in
response to requests from sponsors to
extend the March 28, 2011, effective
date of the final rule. FDA expects all
sponsors and investigators to be in
compliance with the new regulations no
later than September 28, 2011.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002; or the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research,
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
SUMMARY:
E:\FR\FM\07JNR1.SGM
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32864
Federal Register / Vol. 76, No. 109 / Tuesday, June 7, 2011 / Rules and Regulations
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Stephanie Shapley, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6323,
Silver Spring, MD 20993–0002, 301–
796–4836; or Laura Rich, 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:
erowe on DSK5CLS3C1PROD with RULES
I. Background
FDA is announcing the availability of
a guidance for industry and
investigators entitled ‘‘Enforcement of
Safety Reporting Requirements for INDs
and BA/BE Studies.’’ This guidance is
being issued consistent with FDA’s good
guidance practices (GGPs) regulation
(§ 10.115 (21 CFR 10.115)). The
guidance provides that the Agency
intends to grant a 6-month period of
enforcement discretion relating to the
new reporting requirements (described
in this document) that became effective
on March 28, 2011. Accordingly, this
guidance is being implemented without
prior public comment because the
Agency has determined that prior public
participation is not feasible or
appropriate (§ 10.115(g)(2)). The Agency
made this determination because the
guidance deals with a short-term and
highly time-sensitive issue. Although
this guidance document is immediately
in effect, it remains subject to comment
in accordance with the Agency’s GGPs
regulation.
On September 29, 2010, FDA
published a final rule ‘‘Investigational
New Drug Safety Reporting
Requirements for Human Drug and
Biological Products and Safety
Reporting Requirements for
Bioavailability and Bioequivalence
Studies in Humans’’ (75 FR 59935) and
issued related draft guidance ‘‘Safety
Reporting Requirements for INDs and
BA/BE Studies’’ (75 FR 60129, Docket
No. FDA–2010–D–0482). The final rule
amended the investigational new drug
safety reporting requirements under part
312 (21 CFR part 312) and added safety
reporting requirements for persons
conducting bioavailability and
bioequivalence studies under part 320
(21 CFR part 320). The effective date for
the final rule was March 28, 2011. In
comments to the docket, and in other
communications to the Agency placed
in the docket, stakeholders have
requested an extension to the effective
VerDate Mar<15>2010
15:11 Jun 06, 2011
Jkt 223001
date of the final rule because of the need
for significant internal process changes
in order to meet the new requirements.
Specifically, the comments indicated
that sponsors needed additional time to
implement changes to their internal
procedures to comply with the new
reporting requirements. The Agency
acknowledges these concerns and
intends to exercise enforcement
discretion regarding the reporting
requirements in the final rule until
September 28, 2011. During this period
of time, FDA does not intend to take
enforcement action if sponsors and
investigators report in compliance with
the reporting requirements under
§§ 312.32, 312.64, and 320.31 that were
in effect prior to March 28, 2011.
The guidance represents the Agency’s
current thinking on enforcement of
safety reporting requirements for
investigational new drug applications
and bioavailability/bioequivalence
studies. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed 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.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/default.htm, or
https://www.regulations.gov. Always
access an FDA guidance document by
using FDA’s Web site listed previously
to find the most current version of the
guidance.
Dated: June 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–13950 Filed 6–6–11; 8:45 am]
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DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 31
[TD 9524]
RIN 1545–BG45
Extension of Withholding to Certain
Payments Made by Government
Entities; Correction
Internal Revenue Service (IRS),
Treasury.
ACTION: Correction to final regulations.
AGENCY:
This document describes
corrections to final regulations (TD
9524) that were published in the
Federal Register on Monday, May 9,
2011 (76 FR 26583) relating to
withholding by government entities.
These regulations reflect changes in the
law made by the Tax Increase
Prevention and Reconciliation act of
2005 that require Federal, State, and
local government entities to withhold
income tax when making payments to
persons providing property or services.
These regulations affect Federal, State,
and local government entities that will
be required to withhold and report tax
from payments to persons providing
property or services and also affect the
person receiving payments for property
or services from the government
entities.
SUMMARY:
This correction is effective on
June 7, 2011, and is applicable on May
9, 2011.
FOR FURTHER INFORMATION CONTACT: A.
G. Kelley, (202) 622–6040 (not a toll-free
number).
SUPPLEMENTARY INFORMATION:
DATES:
Background
The final regulations that are the
subject of this correction are under
sections 3402(t), 3406(g), 6011(a), 6051,
6071(a), and 6302 of the Internal
Revenue Code.
Need for Correction
As published, final regulations (TD
9524) contain errors that may prove to
be misleading and are in need of
clarification.
Correction of Publication
Accordingly, the publication of the
final regulations (TD 9524) which were
the subject of FR Doc. 2011–10760 is
corrected as follows:
1. On page 26584, column 1, in the
preamble, under the paragraph heading
‘‘Summary of Comments and
Explanation of Provisions’’, the second
paragraph of the column, line 1, the
E:\FR\FM\07JNR1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 109 (Tuesday, June 7, 2011)]
[Rules and Regulations]
[Pages 32863-32864]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13950]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 312 and 320
[Docket No. FDA-2010-D-0482]
Guidance for Industry and Investigators on Enforcement of Safety
Reporting Requirements for Investigational New Drug Applications and
Bioavailability/Bioequivalence Studies; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of guidance.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry and investigators entitled
``Enforcement of Safety Reporting Requirements for INDs and BA/BE
Studies.'' This guidance is intended to inform sponsors and
investigators of FDA's intent to exercise enforcement discretion
regarding the reporting requirements in the final rule,
``Investigational New Drug Safety Reporting Requirements for Human Drug
and Biological Products and Safety Reporting Requirements for
Bioavailability and Bioequivalence Studies in Humans'' (75 FR 59935,
September 29, 2010), until September 28, 2011. This action is being
taken in response to requests from sponsors to extend the March 28,
2011, effective date of the final rule. FDA expects all sponsors and
investigators to be in compliance with the new regulations no later
than September 28, 2011.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research, Food and Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852-1448. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-
[[Page 32864]]
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Stephanie Shapley, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6323, Silver Spring, MD 20993-0002, 301-
796-4836; or Laura Rich, 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
FDA is announcing the availability of a guidance for industry and
investigators entitled ``Enforcement of Safety Reporting Requirements
for INDs and BA/BE Studies.'' This guidance is being issued consistent
with FDA's good guidance practices (GGPs) regulation (Sec. 10.115 (21
CFR 10.115)). The guidance provides that the Agency intends to grant a
6-month period of enforcement discretion relating to the new reporting
requirements (described in this document) that became effective on
March 28, 2011. Accordingly, this guidance is being implemented without
prior public comment because the Agency has determined that prior
public participation is not feasible or appropriate (Sec.
10.115(g)(2)). The Agency made this determination because the guidance
deals with a short-term and highly time-sensitive issue. Although this
guidance document is immediately in effect, it remains subject to
comment in accordance with the Agency's GGPs regulation.
On September 29, 2010, FDA published a final rule ``Investigational
New Drug Safety Reporting Requirements for Human Drug and Biological
Products and Safety Reporting Requirements for Bioavailability and
Bioequivalence Studies in Humans'' (75 FR 59935) and issued related
draft guidance ``Safety Reporting Requirements for INDs and BA/BE
Studies'' (75 FR 60129, Docket No. FDA-2010-D-0482). The final rule
amended the investigational new drug safety reporting requirements
under part 312 (21 CFR part 312) and added safety reporting
requirements for persons conducting bioavailability and bioequivalence
studies under part 320 (21 CFR part 320). The effective date for the
final rule was March 28, 2011. In comments to the docket, and in other
communications to the Agency placed in the docket, stakeholders have
requested an extension to the effective date of the final rule because
of the need for significant internal process changes in order to meet
the new requirements. Specifically, the comments indicated that
sponsors needed additional time to implement changes to their internal
procedures to comply with the new reporting requirements. The Agency
acknowledges these concerns and intends to exercise enforcement
discretion regarding the reporting requirements in the final rule until
September 28, 2011. During this period of time, FDA does not intend to
take enforcement action if sponsors and investigators report in
compliance with the reporting requirements under Sec. Sec. 312.32,
312.64, and 320.31 that were in effect prior to March 28, 2011.
The guidance represents the Agency's current thinking on
enforcement of safety reporting requirements for investigational new
drug applications and bioavailability/bioequivalence studies. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed 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.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov. Always access an FDA guidance document by using
FDA's Web site listed previously to find the most current version of
the guidance.
Dated: June 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-13950 Filed 6-6-11; 8:45 am]
BILLING CODE 4160-01-P
