Agency Information Collection Activities: Proposed Collection: Comment Request, 5388-5389 [2011-2009]
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5388
Federal Register / Vol. 76, No. 20 / Monday, January 31, 2011 / Notices
FOR FURTHER INFORMATION CONTACT:
Carol Drew, Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850–3229, 301–796–
3505.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 10,
2010 (75 FR 32952), FDA announced the
availability of a draft guidance entitled
‘‘‘Harmful and Potentially Harmful
Constituents’ in Tobacco Products as
Used in Section 904(e) of the Federal
Food, Drug, and Cosmetic Act.’’ The
Agency considered received comments
as it finalized this guidance. The
guidance document discusses the
meaning of the term ‘‘harmful and
potentially harmful constituent’’ in the
context of implementing the listing
requirements of section 904(e) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 387d(e)).
On June 22, 2009, the President
signed the Tobacco Control Act (Pub. L.
111–310) into law. The Tobacco Control
Act amended the FD&C Act 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(e) of the FD&C Act, as
added by the Tobacco Control Act,
requires FDA to establish, and
periodically revise as appropriate, ‘‘a list
of harmful and potentially harmful
constituents, including smoke
constituents, to health in each tobacco
product by brand and by quantity in
each brand and subbrand.’’ The
guidance discusses the meaning of the
term ‘‘harmful and potentially harmful
constituent’’ in the context of
implementing the listing requirements
of section 904(e).
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II. Significance of Guidance
This guidance is being issued as a
level 1 guidance consistent with FDA’s
good guidance practices regulation (21
CFR 10.115). The guidance represents
the Agency’s current thinking on the
meaning of the term ‘‘harmful and
potentially harmful constituents’’ in the
context of section 904(e) of the FD&C
Act. 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.
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16:38 Jan 28, 2011
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III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.regulations.gov or https://
www.fda.gov/TobaccoProducts/
GuidanceCompliance
RegulatoryInformation/default.htm.
Dated: January 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–1990 Filed 1–28–11; 8:45 am]
BILLING CODE 4160–01–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 the Office of Management
and Budget (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, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1129.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the Agency; (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
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use of automated collection techniques
or other forms of information
technology.
Proposed Project: Ryan White HIV/
AIDS Program Part F Dental Services
Report (OMB No. 0915–0151)—
[Extension]
The Dental Reimbursement Program
(DRP) and the Community Based Dental
Partnership Program under Part F of the
Ryan White HIV/AIDS Program, offer
funding to accredited dental education
programs to support the provision of
oral health services for HIV-positive
individuals. Institutions eligible for
these Ryan White HIV/AIDS Programs
are accredited schools of dentistry, postdoctoral dental education programs, and
dental hygiene programs.
The DRP Application is the Dental
Services Report that schools and
programs use to apply for funding of
non-reimbursed costs incurred in
providing oral health care to patients
with HIV, or to report annual program
data. Awards are authorized under
section 2692(b) of the Public Health
Service Act (42 U.S.C. 300ff–111(b). The
Dental Services Report collects data in
four different areas: Program
information, patient demographics and
services, funding, and training. It also
requests applicants to provide narrative
descriptions of their services and
facilities, as well as their links and
collaboration with community-based
providers of oral health services.
The primary purpose of collecting this
information annually is to verify
eligibility and determine reimbursement
amounts for DRP applicants, as well as
to document the program
accomplishments of Community-Based
Dental Partnership Program grant
recipients. This information also allows
HRSA to learn about (1) the extent of the
involvement of dental schools and
programs in treating patients with HIV,
(2) the number and characteristics of
clients who receive HIV/AIDS programsupported oral health services, (3) the
types and frequency of the provision of
these services, (4) the non-reimbursed
costs of oral health care provided to
patients with HIV, and (5) the scope of
grant recipients’ community-based
collaborations and training of providers.
In addition to meeting the goal of
accountability to Congress, clients,
advocacy groups, and the general
public, information collected in the
Dental Services Report is critical for
HRSA, state and local grantees, and
individual providers, to help assess the
status of existing HIV-related health
service delivery systems.
The annual estimate of burden is as
follows:
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31JAN1
5389
Federal Register / Vol. 76, No. 20 / Monday, January 31, 2011 / Notices
Number of
respondents
Instrument
Responses
per
respondent
Total
responses
Hours per
response
Total burden
hours
Dental Services Report ........................................................
70
1
70
20
1,400
Total ..............................................................................
70
1
70
20
1,400
E-mail comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–33,
Parklawn Building, 5600 Fishers Lane,
Rockville, Maryland 20857. Written
comments should be received within 60
days of this notice.
Dated: January 25, 2011.
Robert Hendricks,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2011–2009 Filed 1–28–11; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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: Data System for
Organ Procurement and
Transplantation Network (42 CFR Part
121, OMB No. 0915–0184)—[Extension]
Health Resources and Services
Administration
transplantation under contract to HHS.
This is a request for an extension of the
current recordkeeping and reporting
requirements associated with the OPTN.
These data will be used by HRSA in
monitoring the contracts for the OPTN
and the Scientific Registry of Transplant
Recipients (SRTR) and in carrying out
other statutory responsibilities.
Information is needed to match donor
organs with recipients, to monitor
compliance of member organizations
with OPTN rules and requirements, to
ensure that all qualified entities are
accepted for membership in the OPTN,
and to ensure patient safety.
The operation of the Organ
Procurement and Transplantation
Network (OPTN) necessitates certain
recordkeeping and reporting
requirements in order to perform the
functions related to organ
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN
Number of
respondents
Section and activity
Responses per
respondent
40
2
3
1
900
900
900
260
10
2
Total ............................................................................
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121.3(b)(2)—OPTN membership and application requirements ..............................................................................
121.3(b)(4)—Appeal for OPTN membership .....................
121.6(c) (Reporting)—Submitting criteria for organ acceptance .........................................................................
121.6(c) (Disclosure)—Sending criteria to OPOs ..............
121.7(b)(4)—Reasons for Refusal .....................................
121.7(f)—Transplant to prevent organ wastage ................
121.9(b)—Designated Transplant Program Requirements
121.9(d)—Appeal for designation ......................................
954
Total
responses
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.’’
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Hours per
response
Total burden
hours
120
2
15
3
1,800
6
1
1
38
1.5
1
1
900
900
34,200
390
10
2
0.5
0.5
0.5
0.5
5.0
6
450
450
17,100
195
50
12
..........................
36,524
........................
20,063
Dated: January 25, 2011.
Robert Hendricks,
Director, Division of Policy and Information
Coordination.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2011–1997 Filed 1–26–11; 11:15 am]
Center for Scientific Review; Notice of
Closed Meetings
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National Institutes of Health
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
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]]>Agencies
[Federal Register Volume 76, Number 20 (Monday, January 31, 2011)]
[Notices]
[Pages 5388-5389]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2009]
-----------------------------------------------------------------------
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 the Office of Management and Budget
(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, e-mail paperwork@hrsa.gov or
call the HRSA Reports Clearance Officer at (301) 443-1129.
Comments are invited on: (a) The proposed collection of information
for the proper performance of the functions of the Agency; (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: Ryan White HIV/AIDS Program Part F Dental Services
Report (OMB No. 0915-0151)--[Extension]
The Dental Reimbursement Program (DRP) and the Community Based
Dental Partnership Program under Part F of the Ryan White HIV/AIDS
Program, offer funding to accredited dental education programs to
support the provision of oral health services for HIV-positive
individuals. Institutions eligible for these Ryan White HIV/AIDS
Programs are accredited schools of dentistry, post-doctoral dental
education programs, and dental hygiene programs.
The DRP Application is the Dental Services Report that schools and
programs use to apply for funding of non-reimbursed costs incurred in
providing oral health care to patients with HIV, or to report annual
program data. Awards are authorized under section 2692(b) of the Public
Health Service Act (42 U.S.C. 300ff-111(b). The Dental Services Report
collects data in four different areas: Program information, patient
demographics and services, funding, and training. It also requests
applicants to provide narrative descriptions of their services and
facilities, as well as their links and collaboration with community-
based providers of oral health services.
The primary purpose of collecting this information annually is to
verify eligibility and determine reimbursement amounts for DRP
applicants, as well as to document the program accomplishments of
Community-Based Dental Partnership Program grant recipients. This
information also allows HRSA to learn about (1) the extent of the
involvement of dental schools and programs in treating patients with
HIV, (2) the number and characteristics of clients who receive HIV/AIDS
program-supported oral health services, (3) the types and frequency of
the provision of these services, (4) the non-reimbursed costs of oral
health care provided to patients with HIV, and (5) the scope of grant
recipients' community-based collaborations and training of providers.
In addition to meeting the goal of accountability to Congress, clients,
advocacy groups, and the general public, information collected in the
Dental Services Report is critical for HRSA, state and local grantees,
and individual providers, to help assess the status of existing HIV-
related health service delivery systems.
The annual estimate of burden is as follows:
[[Page 5389]]
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Instrument respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Dental Services Report.......... 70 1 70 20 1,400
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Total....................... 70 1 70 20 1,400
----------------------------------------------------------------------------------------------------------------
E-mail comments to paperwork@hrsa.gov or mail the HRSA Reports
Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane,
Rockville, Maryland 20857. Written comments should be received within
60 days of this notice.
Dated: January 25, 2011.
Robert Hendricks,
Director, Division of Policy and Information Coordination.
[FR Doc. 2011-2009 Filed 1-28-11; 8:45 am]
BILLING CODE 4165-15-P
