Agency Information Collection Activities: Proposed Collection; Comment Request; Radioactive Drug Research Committees, 54044-54045 [E7-18646]
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54044
Federal Register / Vol. 72, No. 183 / Friday, September 21, 2007 / Notices
Dated: September 13, 2007.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E7–18494 Filed 9–20–07; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Pharmaceutical Development Study
Food and Drug Administration,
HHS.
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Pharmaceutical Development Study’’
has been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Karen L. Nelson, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4816.
In the
Federal Register of February 13, 2006
(71 FR 7556), the agency announced
that the proposed information collection
had been submitted to OMB for review
and clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0604. The
approval expires on August 31, 2010. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
mstockstill on PROD1PC66 with NOTICES
SUPPLEMENTARY INFORMATION:
Dated: September 14, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–18641 Filed 9–20–07; 8:45 am]
VerDate Aug<31>2005
18:17 Sep 20, 2007
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Food and Drug Administration,
HHS.
[Docket No. 2005N–0353]
BILLING CODE 4160–01–S
[Docket No. 2007N–0337]
AGENCY:
Food and Drug Administration
ACTION:
Food and Drug Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Radioactive Drug
Research Committees
BILLING CODE 4120–01–P
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection contained in
regulations governing the use of
radioactive drugs for basic informational
research.
DATES: Submit written or electronic
comments on the collection of
information by November 20, 2007.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments or https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Karen L. Nelson Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, rm. 1061, Rockville, MD 20857,
301–827–4816.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Radioactive Drug Research
Committees— 21 CFR 361.1 (OMB
Control Number 0910–0053)
Under sections 201, 505, and 701 of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321, 355, and 371), FDA
has the authority to issue regulations
governing the use of radioactive drugs
for basic scientific research. Section
361.1 (21 CFR 361.1) sets forth specific
regulations regarding the establishment
and composition of Radioactive Drug
Research Committees and their role in
approving and monitoring basic
research studies utilizing
radiopharmaceuticals. No basic research
study involving any administration of a
radioactive drug to research subjects is
permitted without the authorization of
an FDA approved Radioactive Drug
Research Committee (§ 361.1(d)(7)). The
type of research that may be undertaken
with a radiopharmaceutical drug must
be intended to obtain basic information
and not to carry out a clinical trial for
safety or efficacy. The types of basic
research permitted are specified in the
regulation, and include studies of
metabolism, human physiology,
pathophysiology, or biochemistry.
Section 361.1(c)(2) requires that each
Radioactive Drug Research Committee
shall select a chairman, who shall sign
all applications, minutes, and reports of
the committee. Each committee shall
meet at least once each quarter in which
research activity has been authorized or
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Federal Register / Vol. 72, No. 183 / Friday, September 21, 2007 / Notices
conducted. Minutes shall be kept and
shall include the numerical results of
votes on protocols involving use in
human subjects. Under § 361.1(c)(3),
each Radioactive Drug Research
Committee shall submit an annual
report to FDA. The annual report shall
include the names and qualifications of
the members of, and of any consultants
used by, the Radioactive Drug Research
Committee, using FDA Form 2914, and
a summary of each study conducted
during the proceeding year, using FDA
Form 2915.
Under § 361.1(d)(5), each investigator
shall obtain the proper consent required
under the regulations. Each female
research subject of childbearing
potential must state in writing that she
is not pregnant, or on the basis of a
pregnancy test be confirmed as not
pregnant.
Under § 361.1(d)(8), the investigator
shall immediately report to the
Radioactive Drug Research Committee
all adverse effects associated with use of
the drug, and the committee shall then
report to FDA all adverse reactions
probably attributed to the use of the
radioactive drug.
Section 361.1(f) sets forth labeling
requirements for radioactive drugs.
These requirements are not in the
reporting burden estimate because they
are information supplied by the Federal
Government to the recipient for the
purposes of disclosure to the public (5
CFR 1320.3(c)(2)).
Types of research studies not
permitted under this regulation are also
specified, and include those intended
for immediate therapeutic, diagnostic,
or similar purposes or to determine the
safety or effectiveness of the drug in
humans for such purposes (i.e., to carry
out a clinical trial for safety or efficacy).
These studies require filing of an
investigational new drug application
(IND) under 21 CFR part 312, and the
associated information collections are
covered in OMB control no. 0910–0014.
The primary purpose of this
collection of information is to determine
if the research studies are being
conducted in accordance with required
regulations and that human subject
safety is assured. If these studies were
not reviewed, human subjects could be
subjected to inappropriate radiation or
pharmacologic risks.
Respondents to this information
collection are the chairperson(s) of each
individual Radioactive Drug Research
Committee, investigators, and
participants in the studies.
The burden estimates are based on
FDA’s experience with these reporting
and recordkeeping requirements over
the past few years and the number of
submissions received by FDA under the
regulations.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR
Section
No. of
Respondents
Forms
No. of Responses
per Respondent
Total Annual
Responses
Hours per
Response
Total Hours
361.1(c)(3)
and (c)(4)
FDA 2914
80
1
80
1
80
361.1(c)(3)
FDA 2915
50
6.8
340
3.5
1,190
50
6.8
340
0.1
34
361.1(d)(8)
Total Reporting
1 There
1,304
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
Annual Frequency
of Recordkeeping
Hours per
Record
Total Hours
361.1(c)(2)
80
4
10
800
361.1(d)(5)
50
6.8
.75
38
Total Recordkeeping
1 There
838
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 14, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–18646 Filed 9–20–07; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4160–01–S
[Docket No. 2007N–0347]
Food and Drug Administration
Information Technology Strategic
Planning; Public Meeting
mstockstill on PROD1PC66 with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
Request for comments.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public meeting to solicit views and
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18:17 Sep 20, 2007
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information from interested persons on
issues concerning how the agency can
best plan and apply information
technology (IT) resources to support the
process for the review of human drug
applications. In particular, FDA is
seeking views and information from
interested persons to identify and
prioritize IT solutions that will support
the process for the review of human
drug applications. To help solicit such
information and views, FDA is seeking
responses to specific questions (see
section IV of this document).
DATES: Public Meeting: The public
meeting will be held on October 19,
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]]>Agencies
[Federal Register Volume 72, Number 183 (Friday, September 21, 2007)]
[Notices]
[Pages 54044-54045]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-18646]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0337]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Radioactive Drug Research Committees
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
contained in regulations governing the use of radioactive drugs for
basic informational research.
DATES: Submit written or electronic comments on the collection of
information by November 20, 2007.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments or https://www.regulations.gov.
Submit written comments on the collection of information to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should
be identified with the docket number found in brackets in the heading
of this document.
FOR FURTHER INFORMATION CONTACT: Karen L. Nelson Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, rm. 1061, Rockville, MD 20857, 301-827-4816.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Radioactive Drug Research Committees-- 21 CFR 361.1 (OMB Control Number
0910-0053)
Under sections 201, 505, and 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 355, and 371), FDA has the authority to
issue regulations governing the use of radioactive drugs for basic
scientific research. Section 361.1 (21 CFR 361.1) sets forth specific
regulations regarding the establishment and composition of Radioactive
Drug Research Committees and their role in approving and monitoring
basic research studies utilizing radiopharmaceuticals. No basic
research study involving any administration of a radioactive drug to
research subjects is permitted without the authorization of an FDA
approved Radioactive Drug Research Committee (Sec. 361.1(d)(7)). The
type of research that may be undertaken with a radiopharmaceutical drug
must be intended to obtain basic information and not to carry out a
clinical trial for safety or efficacy. The types of basic research
permitted are specified in the regulation, and include studies of
metabolism, human physiology, pathophysiology, or biochemistry.
Section 361.1(c)(2) requires that each Radioactive Drug Research
Committee shall select a chairman, who shall sign all applications,
minutes, and reports of the committee. Each committee shall meet at
least once each quarter in which research activity has been authorized
or
[[Page 54045]]
conducted. Minutes shall be kept and shall include the numerical
results of votes on protocols involving use in human subjects. Under
Sec. 361.1(c)(3), each Radioactive Drug Research Committee shall
submit an annual report to FDA. The annual report shall include the
names and qualifications of the members of, and of any consultants used
by, the Radioactive Drug Research Committee, using FDA Form 2914, and a
summary of each study conducted during the proceeding year, using FDA
Form 2915.
Under Sec. 361.1(d)(5), each investigator shall obtain the proper
consent required under the regulations. Each female research subject of
childbearing potential must state in writing that she is not pregnant,
or on the basis of a pregnancy test be confirmed as not pregnant.
Under Sec. 361.1(d)(8), the investigator shall immediately report
to the Radioactive Drug Research Committee all adverse effects
associated with use of the drug, and the committee shall then report to
FDA all adverse reactions probably attributed to the use of the
radioactive drug.
Section 361.1(f) sets forth labeling requirements for radioactive
drugs. These requirements are not in the reporting burden estimate
because they are information supplied by the Federal Government to the
recipient for the purposes of disclosure to the public (5 CFR
1320.3(c)(2)).
Types of research studies not permitted under this regulation are
also specified, and include those intended for immediate therapeutic,
diagnostic, or similar purposes or to determine the safety or
effectiveness of the drug in humans for such purposes (i.e., to carry
out a clinical trial for safety or efficacy). These studies require
filing of an investigational new drug application (IND) under 21 CFR
part 312, and the associated information collections are covered in OMB
control no. 0910-0014.
The primary purpose of this collection of information is to
determine if the research studies are being conducted in accordance
with required regulations and that human subject safety is assured. If
these studies were not reviewed, human subjects could be subjected to
inappropriate radiation or pharmacologic risks.
Respondents to this information collection are the chairperson(s)
of each individual Radioactive Drug Research Committee, investigators,
and participants in the studies.
The burden estimates are based on FDA's experience with these
reporting and recordkeeping requirements over the past few years and
the number of submissions received by FDA under the regulations.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of No. of Responses Total Annual Hours per
21 CFR Section Forms Respondents per Respondent Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
361.1(c)(3) and (c)(4) FDA 2914 80 1 80 1 80
--------------------------------------------------------------------------------------------------------------------------------------------------------
361.1(c)(3) FDA 2915 50 6.8 340 3.5 1,190
--------------------------------------------------------------------------------------------------------------------------------------------------------
361.1(d)(8) ................. 50 6.8 340 0.1 34
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Reporting 1,304
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency of
21 CFR Section Recordkeepers Recordkeeping Hours per Record Total Hours
----------------------------------------------------------------------------------------------------------------
361.1(c)(2) 80 4 10 800
----------------------------------------------------------------------------------------------------------------
361.1(d)(5) 50 6.8 .75 38
----------------------------------------------------------------------------------------------------------------
Total Recordkeeping 838
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: September 14, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-18646 Filed 9-20-07; 8:45 am]
BILLING CODE 4160-01-S
