Agency Information Collection Activities: Proposed Collection; Comment Request; Radioactive Drug Research Committees, 74059-74061 [2010-30038]
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jdjones on DSK8KYBLC1PROD with NOTICES
Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Notices
—Budget and Budget Justification 15
points.
For FY 2011, the two criteria for the
SEDS–AFI FOA will be titled and
weighted as follows:
—Approach 90 points and
—Budget and Budget Justification
10 points.
The criteria titles will match the titles
found in the project description section
of the FOAs. Matching titles will help
applicants to better understand the
connection between the two sections of
the FOAs. The assigned weights better
reflect what ANA considers to be the
most important elements of the project
application. (Legal authority: Section
803(c) of NAPA, as amended.)
ii. ANA Evaluation Criteria: Included
here is a summary of each criterion. The
FOAs will include a more detailed
description of the evaluation criteria
and the associated project description.
(a) Objectives and Need for
Assistance: Under this criterion,
applications will be evaluated on the
applicant’s community and applicant
identification, connection to the
community, community participation in
the project development, the problem
statement, and the briefly stated
objectives.
(b) Outcomes Expected: Under this
criterion, applications will be evaluated
on the strength of the project outcomes
expected, which include the project
goal, the results and benefits expected,
and one project-specific impact
indicator. For language applications that
are designed to teach a Native language,
applicants must include an impact
indicator that shows advancement of
language fluency. All other language
projects should provide an impact
indicator that measures an increase in
community interest to preserve the
language.
(c) Approach: Under this criterion,
the application will be evaluated on the
strength of the project approach. This
criterion includes two sub-criteria: The
project strategy and the OWP. The
project strategy sub-criterion includes a
detailed description of the
implementation plan, community
involvement and outreach during
implementation, and contingency
planning to support project
implementation. In addition,
partnerships and leveraged resources
will be evaluated as to their
contribution within the overall strategy
of project implementation and its
sustainability; however, the target
numbers will not be evaluated or
scored. In this section reviewers will
also consider organizational capacity
and project sustainability. The OWP
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sub-criterion includes a review of the
OWP form and its strength as an
effective implementation tool.
(d) Budget: Under this criterion, the
application will be evaluated on the
strength of the budget and how well it
supports successful completion of the
project objectives. This criterion
includes a line-item budget and budget
justification for each line item for each
budget period.
The changes to the content of
evaluation criteria, and the
complementary changes to the project
description section of the FOA, will
more effectively guide panel reviewers
and applicants on what ANA believes
are critical components of a project
application. (Legal authority: Section
803(c) of NAPA, as amended.)
Dated: November 22, 2010.
Lillian Sparks,
Commissioner, Administration for Native
Americans.
[FR Doc. 2010–29976 Filed 11–29–10; 8:45 am]
BILLING CODE 4184–34–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0583]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Radioactive Drug
Research Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 (21 CFR 361.1).
DATES: Submit either electronic or
written comments on the collection of
information by January 31, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
SUMMARY:
PO 00000
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74059
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:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
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—(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
E:\FR\FM\30NON1.SGM
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74060
Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Notices
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
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 Number 0910–
0014.
The primary purpose of this
collection of information is to determine
whether 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
Number of
respondents
Annual
frequency per
response
Total annual
responses
Hours per
response
21 CFR Section
Forms
361.1(c)(3) & (4) .................
361.1(c)(3) ...........................
361.1(d)(8) ..........................
FDA 2914 ...........................
FDA 2915 ...........................
.............................................
80
50
50
1
6.8
6.8
80
340
340
1
3.5
0.1
80
1,190
34
Total .............................
.............................................
........................
........................
........................
........................
1,304
1
Total hours
There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
Number of
recordkeepers
Annual
frequency per
recordkeeping
361.1(c)(2) ............................................................................
361.1(d)(5) ...........................................................................
80
50
4
6.8
320
340
10
.75
3,200
255
Total ..............................................................................
........................
........................
........................
........................
3,455
21 CFR section
jdjones on DSK8KYBLC1PROD with NOTICES
1 There
Total annual
records
Hours per
record
are no capital costs or operating and maintenance costs associated with this collection of information.
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Total hours
Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Notices
Dated: November 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–30038 Filed 11–29–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0594]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Focus Groups as
Used by the Food and Drug
Administration (All Food and Drug
Administration Regulated Products)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
focus groups as used by FDA to gauge
public opinion on all FDA-regulated
products.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by January 31, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
DATES:
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:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794, e-mail:
Jonnalynn.capezzuto@fda.hhs.gov.
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
74061
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.
Focus Groups as Used by the Food and
Drug Administration (All FDARegulated Products)—(OMB Control
Number 0910–0497)—Extension
FDA conducts focus group interviews
on a variety of topics involving FDAregulated products, including drugs,
biologics, devices, food, tobacco, and
veterinary medicine.
Focus groups provide an important
role in gathering information because
they allow for a more indepth
understanding of consumers’ attitudes,
beliefs, motivations, and feelings than
do quantitative studies. Focus groups
serve the narrowly defined need for
direct and informal opinion on a
specific topic and as a qualitative
research tool have three major purposes:
• To obtain consumer information
that is useful for developing variables
and measures for quantitative studies,
• To better understand consumers’
attitudes and emotions in response to
topics and concepts, and
• To further explore findings
obtained from quantitative studies.
FDA will use focus group findings to
test and refine their ideas but will
generally conduct further research
before making important decisions, such
as adopting new policies and allocating
or redirecting significant resources to
support these policies.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Activity
Number of
respondents
Annual
frequency per
response
Total annual
responses
Hours per
response
Total hours
Focus Group Interviews .......................................................
1,440
1
1,440
1.75
2,520
jdjones on DSK8KYBLC1PROD with NOTICES
1 There
are no capital or operating and maintenance costs associated with this collection of information.
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]]>Agencies
[Federal Register Volume 75, Number 229 (Tuesday, November 30, 2010)]
[Notices]
[Pages 74059-74061]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30038]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0583]
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 (21 CFR 361.1).
DATES: Submit either electronic or written comments on the collection
of information by January 31, 2011.
ADDRESSES: Submit electronic comments on the collection of information
to 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: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3792,
Elizabeth.Berbakos@fda.hhs.gov.
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--(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
[[Page 74060]]
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 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 Number 0910-0014.
The primary purpose of this collection of information is to
determine whether 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section Forms Number of frequency per Total annual Hours per Total hours
respondents response responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
361.1(c)(3) & (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................................. ............................ .............. .............. .............. .............. 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\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR section Number of frequency per Total annual Hours per Total hours
recordkeepers recordkeeping records record
----------------------------------------------------------------------------------------------------------------
361.1(c)(2)..................... 80 4 320 10 3,200
361.1(d)(5)..................... 50 6.8 340 .75 255
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 3,455
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 74061]]
Dated: November 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30038 Filed 11-29-10; 8:45 am]
BILLING CODE 4160-01-P
