Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications, 42900-42901 [E9-20409]
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pwalker on DSK8KYBLC1PROD with NOTICES
42900
Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Notices
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: NIH
Intramural Research Training Program
Applications. Type of Information
Collection Request: Extension of a
currently approved collection. Need and
Use of Information Collection: The
proposed information collection activity
is necessary in order to determine the
eligibility and quality of potential
awardees for traineeships in ten (10)
NIH intramural research training
programs. Frequency of Response: On
occasion. Affected Public: Individuals
seeking intramural training
opportunities and references for these
individuals. Type of Respondents:
Postdoctoral, predoctoral,
postbaccalaureate, technical, clinical,
and student applicants. The annual
reporting burden is as follows:
Estimated Number of Respondents:
67,631; Estimated Number of Responses
per Respondent: 1.0506; Average
Burden Hours Per Response: 0.9545;
and Estimated Total Annual Burden
Hours Requested: 67,825. The
annualized cost to respondents is
estimated at $2,033,085. There are no
Capital Costs to report. There are no
Operating or Maintenance Costs to
report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’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 those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
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22:52 Aug 24, 2009
Jkt 217001
of Management and Budget, Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: Marilyn
Tuttleman, M.S., Chief, Project
Clearance Branch, Office of Policy for
Extramural Research Administration
(OPERA), OER, OD, NIH, One Rockledge
Center, Room 3509, 6705 Rockledge
Drive MSC 7974, Bethesda, MD 20892–
7983, or call non-toll-free number 301–
594–7949 or e-mail your request,
including your address to:
mtuttleman@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
Dated: August 17, 2009.
Steven Alves,
Project Officer, OD, OIR, OITE, National
Institutes of Health.
[FR Doc. E9–20439 Filed 8–24–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0380]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Product
Jurisdiction: Assignment of Agency
Component for Review of Premarket
Applications
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 procedure by which an applicant
may obtain an assignment or
designation determination for
combination products.
DATES: Submit written or electronic
comments on the collection of
information by October 26, 2009.
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
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:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857,
JonnaLynn.Capezzuto@fda.hhs.gov,
301–796–3794.
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.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\25AUN1.SGM
25AUN1
Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Notices
Product Jurisdiction: Assignment of
Agency Component for Review of
Premarket Applications—(OMB Control
Number 0523)—Extension
This regulation relates to agency
management and organization and has
two purposes. The first is to implement
section 503(g) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 353(g)), as
added by the Safe Medical Devices Act
of 1990 (Public Law 101–629), and
amended by the Medical Device User
Fee and Modernization Act of 2002
(Public Law 107–250), by specifying
how FDA will determine the
organizational component within FDA
assigned to have primary jurisdiction for
the premarket review and regulation of
products that are comprised of any
combination of the following products:
(1) A drug and a device; (2) a device and
a biological product; (3) a biological
product and a drug; or (4) a drug, a
device, and a biological product. The
second purpose of this regulation is to
enhance the efficiency of agency
management and operations by
providing procedures for classifying and
determining which agency component
is designated to have primary
jurisdiction for any drug, device, or
biological product where such
jurisdiction is unclear or in dispute.
The regulation establishes a
procedure by which an applicant may
obtain an assignment or designation
determination. The regulation requires
42901
that the request include the identity of
the applicant, a comprehensive
description of the product and its
proposed use, and the applicant’s
recommendation as to which agency
component should have primary
jurisdiction, with an accompanying
statement of reasons. The information
submitted would be used by FDA as the
basis for making the assignment or
designation decision. Most information
required by the regulation is already
required for premarket applications
affecting drugs, devices, biological
products, and combination products.
The respondents will be businesses or
other for-profit organizations.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Part 3
43
1 There
Dated: August 18, 2009.
David Horowitz,
Assistant Commissioner for Policy
[FR Doc. E9–20409 Filed 8–24–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0373]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Mental Models
Study of Recruitment and Retention of
Pregnant Women into an Asthma
Pregnancy Registry
AGENCY:
Food and Drug Administration,
HHS.
pwalker on DSK8KYBLC1PROD with NOTICES
Total Annual
Responses
1
Hours per
Response
43
Total Hours
24
1,032
are no capital costs or operating and maintenance costs associated with this collection of information.
These burden estimates are based on
the number of applications FDA
received over the past 2 fiscal years.
ACTION:
Annual Frequency
per
Response
No. of
Respondents
21 CFR Section
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 and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
VerDate Nov<24>2008
22:52 Aug 24, 2009
Jkt 217001
the information collection provisions of
the Mental Models Study of
Recruitment and Retention of Pregnant
Women into an Asthma Pregnancy
Registry. Pregnancy registries are a
common source of safety information
about medications used during
pregnancy. Together with other
information being collected, FDA will
use the results from this study to better
understand how pregnant women and
their health care providers make
decisions about participation in
pregnancy exposure registries. FDA will
use this new knowledge to develop and
recommend effective ways to support
the involvement of health care providers
and pregnant women in pregnancy
registries. Ultimately, greater
involvement of health care providers
and pregnant women in pregnancy
registries will improve the quality of
safety information gathered through the
registries. Better safety information will
support informed treatment decisions
by health care providers and women
who need prescription medications
while pregnant.
DATES: Submit written or electronic
comments on the collection of
information by October 26, 2009.
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.
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
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: Liz
Berbakos, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857,
Elizabeth.Berbakos@fda.hhs.gov, 301–
796–3792.
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
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
E:\FR\FM\25AUN1.SGM
25AUN1
]]>Agencies
[Federal Register Volume 74, Number 163 (Tuesday, August 25, 2009)]
[Notices]
[Pages 42900-42901]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20409]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0380]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Product Jurisdiction: Assignment of Agency Component
for Review of Premarket Applications
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 procedure by which an
applicant may obtain an assignment or designation determination for
combination products.
DATES: Submit written or electronic comments on the collection of
information by October 26, 2009.
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: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, JonnaLynn.Capezzuto@fda.hhs.gov, 301-796-3794.
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.
[[Page 42901]]
Product Jurisdiction: Assignment of Agency Component for Review of
Premarket Applications--(OMB Control Number 0523)--Extension
This regulation relates to agency management and organization and
has two purposes. The first is to implement section 503(g) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)), as added by
the Safe Medical Devices Act of 1990 (Public Law 101-629), and amended
by the Medical Device User Fee and Modernization Act of 2002 (Public
Law 107-250), by specifying how FDA will determine the organizational
component within FDA assigned to have primary jurisdiction for the
premarket review and regulation of products that are comprised of any
combination of the following products: (1) A drug and a device; (2) a
device and a biological product; (3) a biological product and a drug;
or (4) a drug, a device, and a biological product. The second purpose
of this regulation is to enhance the efficiency of agency management
and operations by providing procedures for classifying and determining
which agency component is designated to have primary jurisdiction for
any drug, device, or biological product where such jurisdiction is
unclear or in dispute.
The regulation establishes a procedure by which an applicant may
obtain an assignment or designation determination. The regulation
requires that the request include the identity of the applicant, a
comprehensive description of the product and its proposed use, and the
applicant's recommendation as to which agency component should have
primary jurisdiction, with an accompanying statement of reasons. The
information submitted would be used by FDA as the basis for making the
assignment or designation decision. Most information required by the
regulation is already required for premarket applications affecting
drugs, devices, biological products, and combination products. The
respondents will be businesses or other for-profit organizations.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Part 3 43 1 43 24 1,032
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
These burden estimates are based on the number of applications FDA
received over the past 2 fiscal years.
Dated: August 18, 2009.
David Horowitz,
Assistant Commissioner for Policy
[FR Doc. E9-20409 Filed 8-24-09; 8:45 am]
BILLING CODE 4160-01-S
