Agency Information Collection Activities: Proposed Collection: Comment Request, 20146-20147 [05-7725]
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20146
Federal Register / Vol. 70, No. 73 / Monday, April 18, 2005 / Notices
Lane, Rockville, MD 20857, 301–594–
2041.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘User Fee Waivers for FDC and CoPackaged HIV Drugs for PEPFAR.’’ The
draft guidance describes the
circumstances under which certain
applications for FDC and copackaged
versions of previously approved
antiretroviral therapies for the treatment
of HIV under PEPFAR will not be
assessed user fees. The draft guidance
also describes circumstances under
which some of the applications that will
be assessed fees may be eligible for a
public health or a barrier-to-innovation
waiver.
As part of PEPFAR, FDA issued in
May 2004 a draft guidance entitled
‘‘Fixed Dose Combination and CoPackaged Drug Products for the
Treatment of HIV’’ (Fixed Dose
Guidance) (69 FR 28931, May 19, 2004).
The Fixed Dose Guidance described
some scenarios for approval of FDC or
copackaged products for the treatment
of HIV, provided examples of drug
combinations considered acceptable for
FDC/copackaging, and examples of
those not considered acceptable for
FDC/copackaging. The draft guidance
also explained that the Federal Food,
Drug, and Cosmetic Act provides for
certain circumstances in which FDA can
grant sponsors a waiver or reduction in
fees. The draft guidance also stated that
the agency was evaluating the
circumstances under which it may grant
user fee waivers or reductions for
sponsors developing FDC and
copackaged versions of previously
approved antiretroviral therapies for the
treatment of HIV. Since issuance of the
Fixed Dose Guidance, several potential
applicants have asked that we clarify
whether sponsors submitting drug
applications under the Fixed Dose
Guidance and under the PEPFAR
program will be required to pay user
fees under the Prescription Drug User
Fee Act (PDUFA) and if so, whether
they would be eligible for a waiver of
those fees. As explained in this draft
guidance, in some of the scenarios
described in the Fixed Dose Guidance,
a sponsor could qualify for fee
exemptions or would only be assessed
a half-fee either because the sponsor is
using an active ingredient that has
already been approved or the
application does not require clinical
data for approval. A sponsor of an
application that would be assessed
either a full- or a half-fee may also
qualify for a waiver of the application
fee under several provisions of PDUFA.
We expect that most of the
applications, products, and
establishments for FDC and copackaged
HIV therapies proposed for use in the
PEPFAR program will either not be
assessed fees in the first instance or will
qualify for a waiver under the special
circumstances part of the barrier-toinnovation user fee waiver.
This draft guidance is being issued
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 waivers of user fees for FDC and
copackaged products for the treatment
of HIV under PEPFAR. 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) written or electronic
comments on the draft guidance. Two
copies of mailed comments are to be
submitted, except that individuals may
submit one copy. Comments are to be
identified with the docket number
found in brackets in the heading of this
document. The draft guidance and
received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm or https://www.fda.gov/
ohrms/dockets/default.htm.
Dated: April 13, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–7729 Filed 4–15–05; 8:45 am]
BILLING CODE 4160–01–S
Number of
respondents
Form
Application .......................................................................................................
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19:12 Apr 15, 2005
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources And Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to OMB under the
Paperwork Reduction Act of 1995. To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, call the HRSA Reports
Clearance Officer on (301) 443–1129.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Proposed Project: Application for
Certification and Recertification as a
Federally Qualified Health Center
(FQHC) Look-Alike (OMB No. 0915–
0142): Revision
The Health Resources and Services
Administration (HRSA) proposes to
revise the application guide used by
organizations applying for certification
or recertificaion as a Federally Qualified
Health Center (FQHC) Look-Alike for
purposes of cost-based reimbursement
under the Medicaid and Medicare
programs. The guide will be revised to
reflect legislative, policy, and technical
changes since August 2003, the issuance
date of the last guidance. The estimated
burden is as follows:
Responses
per
respondent
40
E:\FR\FM\18APN1.SGM
Hours per
response
1
18APN1
100
Total burden
hours
4,000
20147
Federal Register / Vol. 70, No. 73 / Monday, April 18, 2005 / Notices
Number of
respondents
Form
Responses
per
respondent
Hours per
response
Total burden
hours
Recertification ..................................................................................................
100
1
15
1,500
Total ..........................................................................................................
140
........................
........................
5,500
Send comments to Susan G. Queen,
Ph.D., HRSA Reports Clearance Officer,
Room 10–33, Parklawn Building, 5600
Fishers Lane, Rockville, MD 20857.
Written comments should be received
within 60 days of this notice.
Dated: April 12, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and
Coordination.
[FR Doc. 05–7725 Filed 4–15–05; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
Statement of Organization, Functions,
and Delegations of Authority
This notice amends Part A (Office of
the Secretary) of the Statement of
Organization, Functions, and
Delegations of Authority for the
Department of Health and Human
Services (HHS) to reflect a realignment
of functions and responsibilities within
the Office of Inspector General (OIG).
The statement of organization,
functions, and delegations of authority
conforms to and carries out the statutory
requirements for operating OIG. Chapter
AF was last published in its entirety on
July 2, 2004.
The realignment of functions and
responsibilities within OIG has been
done to allow greater staff flexibility and
to better reflect the current work
environment and priorities within the
organization. In addition, this notice
sets forth a number of technical changes
in Chapter AF that serve to update
references to office titles and statutory
authorities.
As amended, Chapter AF now reads
as follows:
Section AF.00, Office of Inspector
General—Mission
The Office of Inspector General (OIG)
was established by law as an
independent and objective oversight
unit of the Department to carry out the
mission of promoting economy,
efficiency and effectiveness through the
elimination of waste, abuse and fraud.
In furtherance of this mission, the
organization:
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16:08 Apr 15, 2005
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A. Conducts and supervises audits,
investigations, inspections and
evaluations relating to HHS programs
and operations.
B. Identifies systemic weaknesses
giving rise to opportunities for fraud
and abuse in HHS programs and
operations and makes recommendations
to prevent their recurrence.
C. Leads and coordinates activities to
prevent and detect fraud and abuse in
HHS programs and operations.
D. Detects wrongdoers and abusers of
HHS programs and beneficiaries so
appropriate remedies may be brought to
bear.
E. Keeps the Secretary and the
Congress fully and currently informed
about problems and deficiencies in the
administration of HHS programs and
operations and about the need for and
progress of corrective action, including
imposing sanctions against providers of
health care under Medicare and
Medicaid who commit certain
prohibited acts.
In support of its mission, OIG carries
out and maintains an internal quality
assurance system and a peer review
system with other Offices of Inspectors
General, including periodic quality
assessment studies and quality control
reviews, to provide reasonable
assurance that applicable laws,
regulations, policies, procedures,
standards, and other requirements are
followed, are effective, and are
functioning as intended in OIG
operations.
Section AF.10, Office of Inspector
General—Organization
There is at the head of OIG a statutory
Inspector General, appointed by the
President and confirmed by the Senate.
This office consists of six organizational
units:
A. Immediate Office of the Inspector
General (AFA)
B. Office of Management and Policy
(AFC)
C. Office of Evaluation and Inspections
(AFE)
D. Office of Counsel to the Inspector
General (AFG)
E. Office of Audit Services (AFH)
F. Office of Investigations (AFJ)
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Section AF.20, Office of Inspector
General—Functions
The component sections that follow
describe the specific functions of the
organization.
Section AFA.00, Immediate Office of
the Inspector General—Mission
The Immediate Office of the Inspector
General (IOIG) is directly responsible for
meeting the statutory mission of OIG as
a whole and for promoting effective OIG
internal quality assurance systems,
including quality assessment studies
and quality control reviews of OIG
processes and products. The office also
plans, conducts and participates in a
variety of interagency cooperative
projects and undertakings relating to
fraud and abuse with the Department of
Justice (DOJ), the Centers for Medicare
& Medicaid Services (CMS) and other
governmental agencies, and is
responsible for the reporting and
legislative and regulatory review
functions required by the Inspector
General Act.
Section AFA.10, Immediate Office of
the Inspector General—Organization
IOIG is comprised of the Inspector
General, the Principal Deputy Inspector
General and an immediate office staff,
including the Office of External Affairs.
Section AFA.20, Immediate Office of
the Inspector General—Functions
As the senior official of the
organization, the Inspector General
supervises the Chief Counsel to the
Inspector General and the Deputy
Inspectors General, who head the major
OIG components. The Inspector General
is appointed by the President, with the
advice and consent of the Senate, and
reports to and is under the general
supervision of the Secretary or, to the
extent such authority is delegated, the
Deputy Secretary, but does not report to
and is not subject to supervision by any
other officer in the Department. In
keeping with the independence
conferred by the Inspector General Act,
the Inspector General assumes and
exercises, through line management, all
functional authorities related to the
administration and management of OIG
and all mission-related authorities
stated or implied in the law or delegated
directly from the Secretary.
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]]>Agencies
[Federal Register Volume 70, Number 73 (Monday, April 18, 2005)]
[Notices]
[Pages 20146-20147]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-7725]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources And Services Administration
Agency Information Collection Activities: Proposed Collection:
Comment Request
In compliance with the requirement for opportunity for public
comment on proposed data collection projects (section 3506(c)(2)(A) of
Title 44, United States Code, as amended by the Paperwork Reduction Act
of 1995, Pub. L. 104-13), the Health Resources and Services
Administration (HRSA) publishes periodic summaries of proposed projects
being developed for submission to OMB under the Paperwork Reduction Act
of 1995. To request more information on the proposed project or to
obtain a copy of the data collection plans and draft instruments, call
the HRSA Reports Clearance Officer on (301) 443-1129.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology.
Proposed Project: Application for Certification and Recertification as
a Federally Qualified Health Center (FQHC) Look-Alike (OMB No. 0915-
0142): Revision
The Health Resources and Services Administration (HRSA) proposes to
revise the application guide used by organizations applying for
certification or recertificaion as a Federally Qualified Health Center
(FQHC) Look-Alike for purposes of cost-based reimbursement under the
Medicaid and Medicare programs. The guide will be revised to reflect
legislative, policy, and technical changes since August 2003, the
issuance date of the last guidance. The estimated burden is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Hours per Total burden
Form respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Application..................................... 40 1 100 4,000
[[Page 20147]]
Recertification................................. 100 1 15 1,500
-----------------
Total....................................... 140 .............. .............. 5,500
----------------------------------------------------------------------------------------------------------------
Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance
Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville,
MD 20857. Written comments should be received within 60 days of this
notice.
Dated: April 12, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and Coordination.
[FR Doc. 05-7725 Filed 4-15-05; 8:45 am]
BILLING CODE 4165-15-P
