Guidance on Positron Emission Tomography Drug Applications-Content and Format for New Drug Applications and Abbreviated New Drug Applications; Availability, 54473-54474 [2011-22373]
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54473
Federal Register / Vol. 76, No. 170 / Thursday, September 1, 2011 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Form name
Nominator ............................
Lead Administrator ..............
Nomination Form ...........................................
Site Visit Availability Calendar .......................
Suggested Interviewees Form .......................
Site Visit Schedule Instructions and Template.
Interview Guide for Lead Administrator .........
Interview Guide for Evaluator ........................
Interview Guide for Program Staff .................
Interview Guide for Community Partners and
Other Stakeholders.
Interview Guide for Community Partners and
Other Stakeholders.
51
12
12
12
1
1
1
1
1
1
1
5
51
12
12
60
12
12
36
48
1
1
1
1
2
1
1
1
24
12
36
48
36
1
1
36
........................................................................
........................
........................
........................
291
Evaluator .............................
Program Staff ......................
State, Local and Tribal
Govt. Sector Partners.
Private Sector Partners .......
Total .............................
Date: August 26, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2011–22384 Filed 8–31–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2000–D–1542 (formerly
Docket No. 00D–0892)]
Guidance on Positron Emission
Tomography Drug Applications—
Content and Format for New Drug
Applications and Abbreviated New
Drug Applications; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘PET Drug Applications—
Content and Format for NDAs and
ANDAs.’’ This document is intended to
assist manufacturers of certain positron
emission tomography (PET) drugs in
submitting new drug applications
(NDAs) or abbreviated new drug
applications (ANDAs) in accordance
with the Federal Food, Drug, and
Cosmetic Act (FD&C Act) and FDA
regulations.
SUMMARY:
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,
srobinson on DSK4SPTVN1PROD with NOTICES
DATES:
16:16 Aug 31, 2011
Silver Spring, MD 20993–0002. 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–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Giaquinto, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6164,
Silver Spring, MD 20993, 301–796–
3416.
SUPPLEMENTARY INFORMATION:
I. Background
Notice.
VerDate Mar<15>2010
Number of
respondents
Avg. burden
per response
(in hrs)
Type of
respondents
Jkt 223001
FDA is announcing the availability of
a guidance for industry entitled ‘‘PET
Drug Applications—Content and Format
for NDAs and ANDAs.’’ The guidance is
intended to assist the manufacturers of
certain PET drugs—fludeoxyglucose F
18 injection, ammonia N 13 injection,
and sodium fluoride F 18 injection—in
submitting NDAs and ANDAs in
accordance with the FD&C Act and FDA
regulations. The guidance states that to
continue marketing these PET drugs for
clinical use, manufacturers of these
drugs must submit NDAs of the type
described in section 505(b)(2) of the
FD&C Act (21 U.S.C. 355(b)(2)) or
ANDAs under section 505(j) of the
FD&C Act by December 12, 2011. The
guidance further explains when
submission of a 505(b)(2) application or
ANDA is appropriate and describes the
information that manufacturers of these
PET drugs include in each type of
application.
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
Total burden
(in hrs)
A revised draft guidance of the same
title was announced in the Federal
Register on February 3, 2011 (76 FR
6143), and Docket No. FDA–2000–D–
1542 was open for comments until April
4, 2011. The February 3, 2011, draft
guidance was a revision of the
document ‘‘Draft Guidance for Industry
on the Content and Format of New Drug
Applications and Abbreviated New
Drug Applications for Certain Positron
Emission Tomography Drug Products,’’
issued on March 10, 2000 (65 FR
13010). The February 3, 2011, revised
guidance was issued as a draft for
comment because FDA’s perspective has
changed significantly since the issuance
of the March 2000 draft guidance. We
received comments from industry and
professional societies. We have carefully
considered and, where appropriate, we
have made corrections, added
information, or clarified the information
in this guidance in response to the
comments or on our own initiative.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on the submission of
NDAs and ANDAs for PET drugs. 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
E:\FR\FM\01SEN1.SGM
01SEN1
54474
Federal Register / Vol. 76, No. 170 / Thursday, September 1, 2011 / Notices
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. Paperwork Reduction Act of 1995
This guidance refers 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
21 CFR part 314 have been approved
under OMB control number 0910–0001;
the collections of information required
on Form FDA–356h have been approved
under OMB control number 0910–0338;
and the collections of information
required on Form FDA–3397 have been
approved under OMB control number
0910–0297.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: August 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–22373 Filed 8–31–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request New proposed
collection, Biospecimen and Physical
Measures Formative Research
Methodology Studies for the National
Children’s Study
Under the provisions of
Section (3507(a)(1)(D)) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health has submitted to the
Office of Management and Budget
(OMB) a request to review and approve
the information collection listed below.
This proposed information collection
was previously published in the Federal
SUMMARY:
Register on April 27, 2011, pages
23609–23611, and allowed 60 days for
public comment. Two written
comments and two verbal comments
were received. The verbal comments
expressed support for the broad scope of
the study. The written comments were
identical and questioned the cost and
utility of the study. The purpose of this
notice is to allow an additional 30 days
for public comment. The National
Institutes of Health may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
October 1, 1995, unless it displays a
currently valid OMB control number.
Proposed Collection: Title:
Biospecimen and Physical Measures
Formative Research Methodology
Studies for the National Children’s
Study (NCS). Type of Information
Request: NEW. Need and Use of
Information Collection: The Children’s
Health Act of 2000 (Pub. L. 106–310)
states:
(a) PURPOSE.—It is the purpose of this
section to authorize the National Institute of
Child Health and Human Development* to
conduct a national longitudinal study of
environmental influences (including
physical, chemical, biological, and
psychosocial) on children’s health and
development.
(b) IN GENERAL.—The Director of the
National Institute of Child Health and
Human Development* shall establish a
consortium of representatives from
appropriate Federal agencies (including the
Centers for Disease Control and Prevention,
the Environmental Protection Agency) to—
(1) plan, develop, and implement a
prospective cohort study, from birth to
adulthood, to evaluate the effects of both
chronic and intermittent exposures on child
health and human development; and
(2) investigate basic mechanisms of
developmental disorders and environmental
factors, both risk and protective, that
influence health and developmental
processes.
(c) REQUIREMENT.—The study under
subsection (b) shall—
(1) incorporate behavioral, emotional,
educational, and contextual consequences to
enable a complete assessment of the physical,
chemical, biological, and psychosocial
environmental influences on children’s wellbeing;
(2) gather data on environmental
influences and outcomes on diverse
populations of children, which may include
the consideration of prenatal exposures; and
(3) consider health disparities among
children, which may include the
consideration of prenatal exposures.
To fulfill the requirements of the
Children’s Health Act, the results of
formative research tests will be used to
maximize the efficiency (measured by
scientific robustness, participant and
infrastructure burden, and cost) of
biospecimen and physical measurement
collection procedures, accompanying
questionnaires, storage and information
management processes, and assay
procedures, thereby informing data
collection methodologies for the
National Children’s Study (NCS)
Vanguard and Main Studies. With this
submission, the NCS seeks to obtain
OMB’s generic clearance to conduct
formative research featuring
biospecimen and physical measurement
collections.
The results from these formative
research projects will inform the
feasibility (scientific robustness),
acceptability (burden to participants
and study logistics) and cost of NCS
Vanguard and Main Study biospecimen
collection procedures and physical
measurements in a manner that
minimizes public information collection
burden compared to burden anticipated
if these projects were incorporated
directly into either the NCS Vanguard or
Main Study. Frequency of Response:
Annual [As needed on an on-going and
concurrent basis]. Affected Public:
Members of the public, researchers,
practitioners, and other health
professionals. Type of Respondents:
Women of child-bearing age, infants,
children, fathers, health care facilities
and professionals, public health
professional organizations and
practitioners, and hospital
administrators. These include both
persons enrolled in the NCS Vanguard
Study and their peers who are not
participating in the NCS Vanguard
Study. Annual reporting burden: See
Table 1. The annualized cost to
respondents is estimated at: $600,000
(based on $10 per hour). There are no
Capital Costs to report. There are no
Operating or Maintenance Costs to
report.
srobinson on DSK4SPTVN1PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN SUMMARY, BIOLOGICAL AND PHYSICAL MEASURES
Estimated
number of
respondents
Data collection activity
Type of respondent
Blood:
Adult ...........................................
NCS participants ..............................
VerDate Mar<15>2010
16:16 Aug 31, 2011
Jkt 223001
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
Estimated
number of
responses per
respondent
4,000
E:\FR\FM\01SEN1.SGM
1
01SEN1
Average
burden hours
per response
0.5
Estimated total
annual burden
hours
requested
2,000
Agencies
[Federal Register Volume 76, Number 170 (Thursday, September 1, 2011)]
[Notices]
[Pages 54473-54474]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22373]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2000-D-1542 (formerly Docket No. 00D-0892)]
Guidance on Positron Emission Tomography Drug Applications--
Content and Format for New Drug Applications and Abbreviated New Drug
Applications; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``PET Drug
Applications--Content and Format for NDAs and ANDAs.'' This document is
intended to assist manufacturers of certain positron emission
tomography (PET) drugs in submitting new drug applications (NDAs) or
abbreviated new drug applications (ANDAs) in accordance with the
Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations.
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. 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-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6164, Silver Spring, MD 20993, 301-796-
3416.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``PET Drug Applications--Content and Format for NDAs and
ANDAs.'' The guidance is intended to assist the manufacturers of
certain PET drugs--fludeoxyglucose F 18 injection, ammonia N 13
injection, and sodium fluoride F 18 injection--in submitting NDAs and
ANDAs in accordance with the FD&C Act and FDA regulations. The guidance
states that to continue marketing these PET drugs for clinical use,
manufacturers of these drugs must submit NDAs of the type described in
section 505(b)(2) of the FD&C Act (21 U.S.C. 355(b)(2)) or ANDAs under
section 505(j) of the FD&C Act by December 12, 2011. The guidance
further explains when submission of a 505(b)(2) application or ANDA is
appropriate and describes the information that manufacturers of these
PET drugs include in each type of application.
A revised draft guidance of the same title was announced in the
Federal Register on February 3, 2011 (76 FR 6143), and Docket No. FDA-
2000-D-1542 was open for comments until April 4, 2011. The February 3,
2011, draft guidance was a revision of the document ``Draft Guidance
for Industry on the Content and Format of New Drug Applications and
Abbreviated New Drug Applications for Certain Positron Emission
Tomography Drug Products,'' issued on March 10, 2000 (65 FR 13010). The
February 3, 2011, revised guidance was issued as a draft for comment
because FDA's perspective has changed significantly since the issuance
of the March 2000 draft guidance. We received comments from industry
and professional societies. We have carefully considered and, where
appropriate, we have made corrections, added information, or clarified
the information in this guidance in response to the comments or on our
own initiative.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on the submission of NDAs and ANDAs for PET
drugs. 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
[[Page 54474]]
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. Paperwork Reduction Act of 1995
This guidance refers 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 21 CFR part 314 have been approved under
OMB control number 0910-0001; the collections of information required
on Form FDA-356h have been approved under OMB control number 0910-0338;
and the collections of information required on Form FDA-3397 have been
approved under OMB control number 0910-0297.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: August 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-22373 Filed 8-31-11; 8:45 am]
BILLING CODE 4160-01-P