Agency Information Collection Activities: Proposed Collection: Comment Request, 5388-5389 [2011-2009]

Download as PDF 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INFORMATION: I. Background In the Federal Register of June 10, 2010 (75 FR 32952), FDA announced the availability of a draft guidance entitled ‘‘‘Harmful and Potentially Harmful Constituents’ in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act.’’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). jlentini on DSKJ8SOYB1PROD with NOTICES 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. VerDate Mar<15>2010 16:38 Jan 28, 2011 Jkt 223001 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 http://www.regulations.gov or http:// 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 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 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: E:\FR\FM\31JAN1.SGM 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 ............................................................................ jlentini on DSKJ8SOYB1PROD with NOTICES 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.’’ VerDate Mar<15>2010 16:38 Jan 28, 2011 Jkt 223001 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 BILLING CODE 4165–15–P PO 00000 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 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\31JAN1.SGM 31JAN1

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]


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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 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
                                 -------------------------------------------------------------------------------
    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