Guidances for Industry and Investigators on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies, and a Small Entity Compliance Guide; Availability, 75439-75440 [2012-30651]
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Federal Register / Vol. 77, No. 245 / Thursday, December 20, 2012 / Notices
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
ACF Reports Clearance Officer.
[FR Doc. 2012–30686 Filed 12–19–12; 8:45 am]
BILLING CODE 4184–09–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0482]
Guidances for Industry and
Investigators on Safety Reporting
Requirements for Investigational New
Drug Applications and Bioavailability/
Bioequivalence Studies, and a Small
Entity Compliance Guide; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of two guidances for
industry and investigators entitled
‘‘Safety Reporting Requirements for
INDs and BA/BE Studies’’ and ‘‘Safety
Reporting Requirements for INDs and
BA/BE Studies—Small Entity
Compliance Guide.’’ These guidances
are intended to help sponsors and
investigators comply with the
requirements in the final rule entitled
‘‘Investigational New Drug Safety
Reporting Requirements for Human
Drug and Biological Products and Safety
Reporting Requirements for
Bioavailability and Bioequivalence
Studies in Humans,’’ published in the
Federal Register on September 29, 2010
(75 FR 59935). FDA has prepared the
Small Entity Compliance Guide in
accordance with the Small Business
Regulatory Enforcement Fairness Act. It
is intended to help small businesses
understand and comply with the
regulations issued by FDA concerning
safety reporting requirements for
investigational new drug applications
tkelley on DSK3SPTVN1PROD with
SUMMARY:
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16:07 Dec 19, 2012
Jkt 229001
(IND) and bioavailability (BA) and
bioequivalence (BE) studies.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidances to the
Office of Communications, 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
documents.
Submit electronic comments on the
guidances to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–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. 6352,
Silver Spring, MD 20993–0002, 301–
796–4836; or Stephen Ripley, 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
two guidances for industry and
investigators entitled ‘‘Safety Reporting
Requirements for INDs and BA/BE
Studies’’ and ‘‘Safety Reporting
Requirements for INDs and BA/BE
Studies—Small Entity Compliance
Guide.’’ These guidances are intended
to help sponsors and investigators
comply with the requirements for IND
safety reporting and safety reporting for
BA and BE studies. In addition, the
Small Entity Compliance Guide is
intended to help small businesses
understand and comply with the
regulations issued by FDA concerning
the safety reporting requirements for
INDs and BA/BE studies. FDA has
prepared the Small Entity Compliance
Guide in accordance with section 212 of
the Small Business Regulatory
Enforcement Fairness Act.
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
75439
On September 29, 2010, FDA
published a final rule amending the IND
safety reporting requirements under 21
CFR part 312 and adding safety
reporting requirements for persons
conducting BA and BE studies under 21
CFR part 320. The requirements in the
final rule are intended to improve the
utility and quality of safety reports,
expedite and strengthen FDA’s ability to
review critical safety information, and
better protect human subjects enrolled
in clinical trials. FDA also published a
draft guidance entitled ‘‘Safety
Reporting Requirements for INDs and
BA/BE Studies’’ on September 29, 2010
(75 FR 60129), and the public was
provided with an opportunity to
comment on it until December 28, 2010.
FDA carefully considered all of the
comments received in developing the
final guidance. The final guidance
includes clarifications and additional
detail regarding the draft guidance
topics as well additional information on
safety reporting issues raised in the
comments.
The final guidance entitled ‘‘Safety
Reporting Requirements for INDs and
BA/BE Studies’’ contains the definitions
used for IND safety reporting, makes
recommendations on when and how to
submit a safety report, and provides
advice on other safety reporting issues
that have generated questions from
sponsors and investigators.
The Small Entity Compliance Guide
provides answers to many frequently
asked questions FDA has received from
investigators and sponsors regarding the
safety reporting requirements that are
applicable to small entities.
In addition, on June 7, 2011, the
Agency published a guidance describing
enforcement discretion with the
reporting requirements until September
28, 2011, to allow sponsors additional
time to make process changes to
implement the final rule (76 FR 32863;
June 7, 2011). At this time, the Agency
is withdrawing this guidance.
These guidances are being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidances represent the Agency’s
current thinking on safety reporting
requirements for IND and BA/BE
studies. They do not create or confer
any rights for or on any person and do
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 either
written comments regarding these
documents to the Division of Dockets
E:\FR\FM\20DEN1.SGM
20DEN1
75440
Federal Register / Vol. 77, No. 245 / Thursday, December 20, 2012 / Notices
Management (see ADDRESSES) or
electronic comments to https://
www.regulations.gov. It is only
necessary to send one set of 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, and
will be posted to the docket at https://
www.regulations.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
III. Paperwork Reduction Act of 1995
SUMMARY:
These guidances refer to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
these guidances have been approved
under OMB control number 0910–0672.
IV. Electronic Access
Persons with access to the Internet
may obtain the documents at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm, or https://
www.regulations.gov.
Dated: December 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–30651 Filed 12–19–12; 8:45 am]
BILLING CODE 4160–01–P
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB Review
and Approval; Public Comment
Request
ACTION:
Notice.
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 (44 U.S.C.
Chapter 35), the Health Resources and
Services Administration (HRSA) will
submit an Information Collection
Request (ICR) to the Office of
Management and Budget (OMB).
Comments submitted during the first
public review of this ICR will be
provided to OMB. OMB will accept
further comments from the public
during the review and approval period.
To request a copy of the clearance
requests submitted to OMB for review,
email paperwork@hrsa.gov or call the
HRSA Reports Clearance Office at 301–
443–1984.
Information Collection Request Title:
National Health Service Corps Travel
Request Worksheet (OMB No. 0915–
0278)—Revision
Abstract: Clinicians participating in
the HRSA National Health Service
Corps (NHSC) Scholarship Program use
the online Travel Request Worksheet to
request travel funds from the Federal
Government to perform pre-employment
Number of
respondents
Instrument
Responses
per
respondent
interviews at sites on the NHSC’s
Opportunities List. The travel approval
process is initiated when a scholar
notifies the NHSC of an impending
interview at one or more NHSC
approved practice sites. The Travel
Request Worksheet is also used to
initiate the relocation process after a
NHSC scholar has successfully been
matched to an approved practice site.
Upon receipt of the Travel Request
Worksheet, the NHSC will review and
approve or disapprove the request and
promptly notify the scholar and the
NHSC logistics contractor regarding
travel arrangements and authorization of
the funding for the site visit or
relocation.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions, to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information, to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information, and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
The annual estimate of burden is as
follows:
Total
responses
Hours per
response
Total burden
hours
Scholar Travel Request Worksheet .....................................
180
2
360
.0667
24
Total ..............................................................................
180
2
360
.0667
24
Submit your comments to
the desk officer for HRSA, either by
email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806. Please direct all
correspondence to the ‘‘attention of the
desk officer for HRSA.’’
Deadline: Comments on this ICR
should be received within 30 days of
this notice.
tkelley on DSK3SPTVN1PROD with
ADDRESSES:
Dated: December 14, 2012.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2012–30690 Filed 12–19–12; 8:45 am]
BILLING CODE 4165–15–P
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DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
[OMB Control Number 1615–0052]
Agency Information Collection
Activities: Application for
Naturalization, Form Number N–400;
Revision of a Currently Approved
Collection
ACTION:
60-Day notice.
The Department of Homeland
Security (DHS), U.S. Citizenship and
Immigration Services (USCIS) invites
SUMMARY:
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Fmt 4703
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the general public and other Federal
agencies to comment upon this
proposed revision of a currently
approved collection of information. In
accordance with the Paperwork
Reduction Act of 1995, the information
collection notice is published in the
Federal Register to obtain comments
regarding the nature of the information
collection, the categories of
respondents, the estimated burden (i.e.
the time, effort, and resources used by
the respondents to respond), the
estimated cost to the respondent, and
the actual information collection
instruments.
E:\FR\FM\20DEN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 245 (Thursday, December 20, 2012)]
[Notices]
[Pages 75439-75440]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30651]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0482]
Guidances for Industry and Investigators on Safety Reporting
Requirements for Investigational New Drug Applications and
Bioavailability/Bioequivalence Studies, and a Small Entity Compliance
Guide; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of two guidances for industry and investigators entitled
``Safety Reporting Requirements for INDs and BA/BE Studies'' and
``Safety Reporting Requirements for INDs and BA/BE Studies--Small
Entity Compliance Guide.'' These guidances are intended to help
sponsors and investigators comply with the requirements in the final
rule entitled ``Investigational New Drug Safety Reporting Requirements
for Human Drug and Biological Products and Safety Reporting
Requirements for Bioavailability and Bioequivalence Studies in
Humans,'' published in the Federal Register on September 29, 2010 (75
FR 59935). FDA has prepared the Small Entity Compliance Guide in
accordance with the Small Business Regulatory Enforcement Fairness Act.
It is intended to help small businesses understand and comply with the
regulations issued by FDA concerning safety reporting requirements for
investigational new drug applications (IND) and bioavailability (BA)
and bioequivalence (BE) studies.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of the guidances
to the Office of Communications, 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 documents.
Submit electronic comments on the guidances to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-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. 6352, Silver Spring, MD 20993-0002, 301-
796-4836; or Stephen Ripley, 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 two guidances for industry
and investigators entitled ``Safety Reporting Requirements for INDs and
BA/BE Studies'' and ``Safety Reporting Requirements for INDs and BA/BE
Studies--Small Entity Compliance Guide.'' These guidances are intended
to help sponsors and investigators comply with the requirements for IND
safety reporting and safety reporting for BA and BE studies. In
addition, the Small Entity Compliance Guide is intended to help small
businesses understand and comply with the regulations issued by FDA
concerning the safety reporting requirements for INDs and BA/BE
studies. FDA has prepared the Small Entity Compliance Guide in
accordance with section 212 of the Small Business Regulatory
Enforcement Fairness Act.
On September 29, 2010, FDA published a final rule amending the IND
safety reporting requirements under 21 CFR part 312 and adding safety
reporting requirements for persons conducting BA and BE studies under
21 CFR part 320. The requirements in the final rule are intended to
improve the utility and quality of safety reports, expedite and
strengthen FDA's ability to review critical safety information, and
better protect human subjects enrolled in clinical trials. FDA also
published a draft guidance entitled ``Safety Reporting Requirements for
INDs and BA/BE Studies'' on September 29, 2010 (75 FR 60129), and the
public was provided with an opportunity to comment on it until December
28, 2010. FDA carefully considered all of the comments received in
developing the final guidance. The final guidance includes
clarifications and additional detail regarding the draft guidance
topics as well additional information on safety reporting issues raised
in the comments.
The final guidance entitled ``Safety Reporting Requirements for
INDs and BA/BE Studies'' contains the definitions used for IND safety
reporting, makes recommendations on when and how to submit a safety
report, and provides advice on other safety reporting issues that have
generated questions from sponsors and investigators.
The Small Entity Compliance Guide provides answers to many
frequently asked questions FDA has received from investigators and
sponsors regarding the safety reporting requirements that are
applicable to small entities.
In addition, on June 7, 2011, the Agency published a guidance
describing enforcement discretion with the reporting requirements until
September 28, 2011, to allow sponsors additional time to make process
changes to implement the final rule (76 FR 32863; June 7, 2011). At
this time, the Agency is withdrawing this guidance.
These guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidances represent
the Agency's current thinking on safety reporting requirements for IND
and BA/BE studies. They do not create or confer any rights for or on
any person and do 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 either written comments regarding
these documents to the Division of Dockets
[[Page 75440]]
Management (see ADDRESSES) or electronic comments to https://www.regulations.gov. It is only necessary to send one set of 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,
and will be posted to the docket at https://www.regulations.gov.
III. Paperwork Reduction Act of 1995
These guidances refer to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in these guidances have been approved under
OMB control number 0910-0672.
IV. Electronic Access
Persons with access to the Internet may obtain the documents at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.
Dated: December 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30651 Filed 12-19-12; 8:45 am]
BILLING CODE 4160-01-P
