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availability of a draft guidance entitled 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). 

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. 

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 

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: 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 76, No. 20 / Monday, January 31, 2011 / Notices 5389 

Instrument Number of 

respondents 

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 

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: Data System for 

Organ Procurement and 

Transplantation Network (42 CFR Part 

121, OMB No. 0915–0184)—[Extension] 

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 

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. 

ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN

Section and activity Number of 

respondents 

Responses per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

121.3(b)(2)—OPTN membership and application requirements .............................................................................. 40 3 120 15 1,800 

121.3(b)(4)—Appeal for OPTN membership ..................... 2 1 2 3 6 

121.6(c) (Reporting)—Submitting criteria for organ acceptance ......................................................................... 900 1 900 0.5 450 

121.6(c) (Disclosure)—Sending criteria to OPOs .............. 900 1 900 0.5 450 

121.7(b)(4)—Reasons for Refusal ..................................... 900 38 34,200 0.5 17,100 

121.7(f)—Transplant to prevent organ wastage ................ 260 1 .5 390 0.5 195 

121.9(b)—Designated Transplant Program Requirements 10 1 10 5.0 50 

121.9(d)—Appeal for designation ...................................... 2 1 2 6 12 

Total ............................................................................ 954 .......................... 36,524 ........................ 20,063 

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: January 25, 2011. 

Robert Hendricks, 

Director, Division of Policy and Information 

Coordination. 

[FR Doc. 2011–1997 Filed 1–26–11; 11:15 am] 

BILLING CODE 4165–15–P 

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 


jlentini on DSKJ8SOYB1PROD with NOTICES