Agency Information Collection Activities: Submission for OMB Review; Comment Request, 7748-7749 [05-2818]
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7748
Federal Register / Vol. 70, No. 30 / Tuesday, February 15, 2005 / Notices
16, 2005. General comments on agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of this draft guidance to
the Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Submit written comments on the draft
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Patricia A. Stewart, Center for Drug
Evaluation and Research (HFD–160),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–827–7510.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Internal Radioactive Contamination—
Development of Decorporation Agents.’’
This draft guidance is being issued to
facilitate the development of new
decorporation agents or new uses of
previously marketed medical products
for the treatment of internal radioactive
contamination.
Internal radioactive contamination
can arise from accidents involving
nuclear reactors, industrial sources, or
medical sources. The potential for such
accidents has been present for many
years. Recent events also have
highlighted the potential for
nonaccidental radioactive
contamination as a result of malicious,
criminal, or terrorist actions. Internal
contamination occurs when radioactive
material is ingested, inhaled, or
absorbed from a contaminated wound.
As long as these radioactive
contaminants remain in the body, they
may pose significant health risks. Longterm health concerns include the
potential for the development of cancers
of the lung, liver, thyroid, stomach, and
bone and, when a radioactive
contaminant is inhaled, for the
development of fibrotic changes in the
lung that may lead to restrictive lung
disease. The only effective method of
reducing these risks is removal of the
radioactive contaminants from the body.
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‘‘Decorporation agents’’ refer to
medical products that increase the rate
of elimination or excretion of inhaled,
ingested, or absorbed radioactive
contaminants. The effectiveness of most
decorporation agents for the treatment
of internal radioactive contamination
cannot be tested in humans because the
occurrence of accidental or
nonaccidental radioactive
contamination is rare, and it would be
unethical to deliberately contaminate
human volunteers with potentially
harmful amounts of radioactive
materials for investigational purposes.
FDA is issuing this draft guidance to
facilitate the development of new
decorporation agents or new indications
for previously marketed medical
products that may be eligible for
approval under the Animal Efficacy
Rule (21 CFR part 314, subpart I and 21
CFR part 601, subpart H). As set forth
in this rule, under certain circumstances
animal studies can be relied on to
provide substantial evidence of
effectiveness of a product. Evaluation of
the product for safety in humans is still
required, and cannot be addressed by
animal studies alone. The adequacy of
human safety data will need to be
assessed from clinical pharmacology
and safety studies conducted in
humans. This draft guidance addresses
the design and conduct of the requisite
CMC, animal efficacy, safety
pharmacology, toxicology, clinical
pharmacology, biopharmaceutics, and
human safety studies needed to support
approval of new decorporation agents or
new uses of previously marketed
medical products for the treatment of
internal radioactive contamination.
In addition, approval under the
Animal Efficacy Rule is subject to
certain postapproval commitments,
including submission of a plan for
conducting postmarketing studies that
would be feasible should an accidental
or intentional release of radiation occur,
postmarketing restrictions to ensure safe
use, if deemed necessary, and product
labeling information intended for the
patient advising that, among other
things, the product’s approval was
based on effectiveness studies
conducted in animals alone. This draft
guidance addresses the postapproval
commitments that would be needed for
approval of a new decorporation agent
or for a new indication for a previously
approved agent under the Animal
Efficacy Rule.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on the development of
decorporation agents for the treatment
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of internal radioactive contamination. 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 guidance at any time.
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 http:/
/www.fda.gov/cder/guidance/index.htm
or https://www.fda.gov/ohrms/dockets/
default.htm.
Dated: February 4, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–2821 Filed 2–14–05; 8:45 am]
BILLING CODE 4160–01–S
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, 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:
E:\FR\FM\15FEN1.SGM
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7749
Federal Register / Vol. 70, No. 30 / Tuesday, February 15, 2005 / Notices
Proposed Project: Bureau of Primary
Health Care (BPHC) Uniform Data
System (OMB No. 0915–0193)—
Extension
The Uniform Data System (UDS)
contains the annual reporting
requirements for the cluster of primary
care grantees funded by the Bureau of
Primary Health Care (BPHC), Health
Resources and Services Administration
(HRSA). The UDS is a reporting
requirement for grantees of the
Consolidated Health Center Program
(the Program), which provides support
to community health centers, migrant
health centers, health care for the
homeless centers, public housing
primary care centers, and other grantees
under the Program’s authorizing statute
(section 330 of the Public Health Service
Act, as amended).
The Bureau collects data in the UDS
which is used to ensure compliance
Number of
respondents
Type of report
Responses
per
respondent
with legislative mandates and to report
to Congress and policymakers on
program accomplishments. To meet
these objectives, BPHC requires a core
set of data collected annually that is
appropriate for monitoring and
evaluating performance and reporting
on annual trends.
Estimates of annualized reporting
burden are as follows:
Total
responses
Hours per
response
Total burden
hours
Universal Report ..................................................................
Grant Report ........................................................................
920
125
1
1
920
125
27
18
24,840
2,250
Total .....................................................................................
920
........................
1045
........................
27,090
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to:
John Kraemer, Human Resources and
Housing Branch, Office of Management
and Budget, New Executive Office
Building, Room 10235, Washington, DC
20503.
Dated: February 8, 2005.
Steven A. Pelovitz,
Associate Administrator for Administration
and Financial Management.
[FR Doc. 05–2818 Filed 2–14–05; 8:45 am]
BILLING CODE 4165–15–P
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: Disadvantaged
Assistance Tracking and Outcome
Report (OMB No. 0915–0233)—
Extension
The Health Careers Opportunity
Program (HCOP) and the Centers of
Excellence (COE) Program (sections 740
and 739 of the Public Health Service
(PHS) Act, respectively) provide
opportunities for under-represented
minorities and disadvantaged
individuals to enter and graduate from
health professions schools. The
Disadvantaged Assistance Tracking and
Outcome Report (DATOR), is used to
track program participants throughout
the health professions pipeline into the
health care workforce.
The DATOR, to be completed
annually by HCOP and COE grantees,
includes basic data on student
participants (name, social security
number, gender, race/ethnicity; targeted
health professions, their status in the
educational pipeline from preprofessional through professional
training; financial assistance received
through the grants funded under
sections 739 and 740 of the PHS Act in
the form of stipends, fellowships or per
diem; and their employment or practice
setting following their entry into the
health care work force).
The proposed reporting instrument
does not add significantly to the
grantees reporting burden. This
reporting instrument complements the
grantees internal automated reporting
mechanisms of using name and social
security number in tracking students.
The reporting burden includes the total
time, effort, and financial resources
expended to maintain, retain and
provide the information including: (1)
Reviewing instructions; (2)
downloading and utilizing technology
for the purposes of collecting,
validating, and processing the data; and
(3) transmitting electronically, or
otherwise disclosing the information.
Estimates of annualized burden are as
follows:
Type of report
Number of
respondents
Responses
per
respondent
Hours per
response
Total burden
hours
DATOR ............................................................................................................
150
1
5.5
825
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]]>Agencies
[Federal Register Volume 70, Number 30 (Tuesday, February 15, 2005)]
[Notices]
[Pages 7748-7749]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-2818]
-----------------------------------------------------------------------
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, 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:
[[Page 7749]]
Proposed Project: Bureau of Primary Health Care (BPHC) Uniform Data
System (OMB No. 0915-0193)--Extension
The Uniform Data System (UDS) contains the annual reporting
requirements for the cluster of primary care grantees funded by the
Bureau of Primary Health Care (BPHC), Health Resources and Services
Administration (HRSA). The UDS is a reporting requirement for grantees
of the Consolidated Health Center Program (the Program), which provides
support to community health centers, migrant health centers, health
care for the homeless centers, public housing primary care centers, and
other grantees under the Program's authorizing statute (section 330 of
the Public Health Service Act, as amended).
The Bureau collects data in the UDS which is used to ensure
compliance with legislative mandates and to report to Congress and
policymakers on program accomplishments. To meet these objectives, BPHC
requires a core set of data collected annually that is appropriate for
monitoring and evaluating performance and reporting on annual trends.
Estimates of annualized reporting burden are as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Type of report respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Universal Report................ 920 1 920 27 24,840
Grant Report.................... 125 1 125 18 2,250
-----------------
Total........................... 920 .............. 1045 .............. 27,090
----------------------------------------------------------------------------------------------------------------
Written comments and recommendations concerning the proposed
information collection should be sent within 30 days of this notice to:
John Kraemer, Human Resources and Housing Branch, Office of Management
and Budget, New Executive Office Building, Room 10235, Washington, DC
20503.
Dated: February 8, 2005.
Steven A. Pelovitz,
Associate Administrator for Administration and Financial Management.
[FR Doc. 05-2818 Filed 2-14-05; 8:45 am]
BILLING CODE 4165-15-P
