Agency Information Collection Activities: Submission for OMB Review; Comment Request, 68628-68629 [E9-30606]
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Federal Register / Vol. 74, No. 247 / Monday, December 28, 2009 / Notices
(3) Requester’s potential for reaching
underserved/special populations;
(4) Requester’s experience
administering national awards
programs;
(5) Requester’s past or current work
specific to national programs or projects
in the area(s) of physical activity,
fitness, or sports among individuals and
in schools and organizations;
(6) Requester’s personnel: name,
professional qualifications and specific
expertise of key personnel who would
be available to work on these projects;
(7) Requester’s facilities: availability
and description of facilities required to
administer the program including office
space and information technology and
telecommunication resources;
(8) Requester’s description of
financial management: discussion of
experience in developing an annual
budget and collecting and managing
monies from organizations and
individuals;
(9) Requester’s proposed plan for
managing the PCPFS awards programs,
including such financial aspects as Web
site development and/or enhancement,
cost of program materials and
distribution of those items.
Availability of Funds: There are no
Federal funds available for this cosponsorship.
Dated: December 22, 2009.
Penelope Slade-Sawyer,
RADM U.S. Public Health Service, Acting
Executive Director, President’s Council on
Physical Fitness and Sports, U.S. Department
of Health and Human Services.
[FR Doc. E9–30653 Filed 12–24–09; 8:45 am]
BILLING CODE 4150–35–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Office on (301) 443–
1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Proposed Project: Drug Pricing Program
Reporting Requirements (OMB No.
0915–0176)—[Extension]
Section 602 of Public Law 102–585,
the Veterans Health Care Act of 1992,
Number of respondents
Instrument
Responses per
respondent
enacted section 340B of the Public
Health Service Act (PHS Act)
‘‘Limitation on Prices of Drugs
Purchased by Covered Entities.’’ Section
340B provides that a manufacturer who
sells covered outpatient drugs to eligible
entities must sign a pharmaceutical
pricing agreement with the Secretary of
Health and Human Services in which
the manufacturer agrees to charge a
price for covered outpatient drugs that
will not exceed an amount determined
under a statutory formula. Covered
entities which choose to participate in
the section 340B drug discount program
must comply with the requirements of
340B(a)(5) of the PHS Act. Section
340B(a)(5)(A) prohibits a covered entity
from accepting a discount for a drug that
would also generate a Medicaid rebate.
Further, section 340B(a)(5)(B) prohibits
a covered entity from reselling or
otherwise transferring a discounted drug
to a person who is not a patient of the
entity.
In response to the statutory mandate
of section 340B(a)(5)(C) to develop audit
guidelines and because of the potential
for disputes involving covered entities
and participating drug manufacturers,
the HRSA Office of Pharmacy Affairs
(OPA) developed a dispute resolution
process for manufacturers and covered
entities as well as manufacturer
guidelines for audit of covered entities.
The annual estimate of burden is as
follows:
Total responses
Hours per response
Total burden
hours
1
1
1
0
2
1
1
0
4
8
1
0
8
8
1
0
4
1
8
2
10
16
80
32
Audits
Audit Notification of Entity ..............................
Audit Work Plan .............................................
Audit Report ...................................................
Entity Response .............................................
2
1
1
0
Dispute Resolution
Dispute Resolution Request ..........................
Rebuttal ..........................................................
2
2
Record Keeping Requirement
10
1
10
.5
5
Total Recordkeeping ...............................
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Dispute Records ............................................
10
............................
............................
..............................
5
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Federal Register / Vol. 74, No. 247 / Monday, December 28, 2009 / Notices
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
the desk officer for HRSA, either by
email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974. Please direct all
correspondence to the ‘‘attention of the
desk officer for HRSA.’’
Dated: December 18, 2009.
Alexandra Huttinger,
Director, Division of Policy Review and
Coordination.
[FR Doc. E9–30606 Filed 12–24–09; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0600]
Draft Guidance for Industry on
Tobacco Health Document
Submission; Availability
AGENCY:
Food and Drug Administration,
HHS.
erowe on DSK5CLS3C1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance
document entitled ‘‘Tobacco Health
Document Submission.’’ The draft
guidance is intended to assist persons
making certain document submissions
to FDA under the Family Smoking
Prevention and Tobacco Control Act
(Tobacco Control Act).
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by January 22, 2010.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘Tobacco Health
Document Submission’’ to the Center for
Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850–3229. Send one
self-addressed adhesive label to assist
that office in processing your request or
include a fax number to which the draft
guidance document may be sent.
Submit electronic comments to https://
www.regulations.gov. Submit written
comments on the guidance to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Identify comments with the
VerDate Nov<24>2008
11:00 Dec 24, 2009
Jkt 220001
docket number found in brackets in the
heading of this document. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT: May
Nelson, Center for Tobacco Products,
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850–
3229, 240–276–1717,
May.Nelson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On June 22, 2009, the President
signed the Tobacco Control Act (Public
Law 111–31) into law. The Tobacco
Control Act amended the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 301 et seq.) by, among other
things, adding a new chapter granting
FDA important new authority to
regulate the manufacture, marketing,
and distribution of tobacco products to
protect the public health generally and
to reduce tobacco use by minors.
Section 904(a)(4) of the act, as
amended by the Tobacco Control Act,
requires each tobacco product
manufacturer or importer, or agent
thereof, to submit all documents
developed after June 22, 2009, ‘‘* * *
that relate to health, toxicological,
behavioral, or physiologic effects of
current or future tobacco products, their
constituents (including smoke
constituents), ingredients, components,
and additives.’’ Information required
under section 904(a)(4) of the act must
be submitted to FDA beginning
December 22, 2009. FDA recognizes the
challenges associated with the
collection, review, organization, and
production of documents. We also
recognize that additional time may be
necessary for the production of
documents in a digital format, which
FDA strongly encourages in order to
improve the management and
accessibility of submitted documents.
Therefore, FDA does not intend to
enforce the December 22, 2009, deadline
provided you submit by April 30, 2009,
all documents described in section
904(a)(4) of the act developed between
June 23, 2009, and March 31, 2010.
II. Significance of Guidance
FDA is issuing this draft guidance
document consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the agency’s
current thinking on ‘‘Tobacco Health
Document Submission.’’ 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
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68629
approach may be used if such approach
satisfies the requirements of the
applicable statute and regulations.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. The draft
guidance document and received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. Paperwork Reduction Act of 1995
This draft guidance contains proposed
collections of information that are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501–3520). As
required by the PRA, FDA has
published an analysis of, among other
information collections, the information
collection concerning the submission of
tobacco health documents (74 FR 45219,
September 1, 2009, as corrected by 74
FR 47257, September 15, 2009) and will
submit them for OMB approval.
V. Electronic Access
An electronic version of the guidance
document is available on the Internet at
https://www.regulations.gov and https://
www.fda.gov/TobaccoProducts/
GuidanceComplianceRegulatory
Information/default.htm.
Dated: December 22, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–30657 Filed 12–22–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
E:\FR\FM\28DEN1.SGM
28DEN1
]]>Agencies
[Federal Register Volume 74, Number 247 (Monday, December 28, 2009)]
[Notices]
[Pages 68628-68629]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-30606]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources and Services Administration
(HRSA) publishes abstracts of information collection requests under
review by the Office of Management and Budget (OMB), in compliance with
the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request
a copy of the clearance requests submitted to OMB for review, e-mail
paperwork@hrsa.gov or call the HRSA Reports Clearance Office on (301)
443-1129.
The following request has been submitted to the Office of
Management and Budget for review under the Paperwork Reduction Act of
1995:
Proposed Project: Drug Pricing Program Reporting Requirements (OMB No.
0915-0176)--[Extension]
Section 602 of Public Law 102-585, the Veterans Health Care Act of
1992, enacted section 340B of the Public Health Service Act (PHS Act)
``Limitation on Prices of Drugs Purchased by Covered Entities.''
Section 340B provides that a manufacturer who sells covered outpatient
drugs to eligible entities must sign a pharmaceutical pricing agreement
with the Secretary of Health and Human Services in which the
manufacturer agrees to charge a price for covered outpatient drugs that
will not exceed an amount determined under a statutory formula. Covered
entities which choose to participate in the section 340B drug discount
program must comply with the requirements of 340B(a)(5) of the PHS Act.
Section 340B(a)(5)(A) prohibits a covered entity from accepting a
discount for a drug that would also generate a Medicaid rebate.
Further, section 340B(a)(5)(B) prohibits a covered entity from
reselling or otherwise transferring a discounted drug to a person who
is not a patient of the entity.
In response to the statutory mandate of section 340B(a)(5)(C) to
develop audit guidelines and because of the potential for disputes
involving covered entities and participating drug manufacturers, the
HRSA Office of Pharmacy Affairs (OPA) developed a dispute resolution
process for manufacturers and covered entities as well as manufacturer
guidelines for audit of covered entities.
The annual estimate of burden is as follows:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses per Hours per Total burden
Instrument respondents respondent Total responses response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Audits
--------------------------------------------------------------------------------------------------------------------------------------------------------
Audit Notification of Entity................................. 2 1 2 4 8
Audit Work Plan.............................................. 1 1 1 8 8
Audit Report................................................. 1 1 1 1 1
Entity Response.............................................. 0 0 0 0 0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dispute Resolution
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dispute Resolution Request................................... 2 4 8 10 80
Rebuttal..................................................... 2 1 2 16 32
--------------------------------------------------------------------------------------------------------------------------------------------------------
Record Keeping Requirement
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dispute Records.............................................. 10 1 10 .5 5
------------------------------------------------------------------------------------------
Total Recordkeeping...................................... 10 ................ ................ ................. 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 68629]]
Written comments and recommendations concerning the proposed
information collection should be sent within 30 days of this notice to
the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to 202-395-6974. Please direct all
correspondence to the ``attention of the desk officer for HRSA.''
Dated: December 18, 2009.
Alexandra Huttinger,
Director, Division of Policy Review and Coordination.
[FR Doc. E9-30606 Filed 12-24-09; 8:45 am]
BILLING CODE 4165-15-P
