Federal Register / Vol. 77, No. 36 / Thursday, February 23, 2012 / Notices 10755 

solvent (i.e., a solvent with low 

toxicity). The Q3C EWG reviewed new 

toxicity data derived from a 

carcinogenicity study performed by the 

National Toxicology Program. The new 

data suggest a positive systemic 

carcinogenic effect, and this observation 

raises the toxicity associated with this 

solvent. The final recommendation is 

that cumene be placed into class 2. A 

PDE of 0.7 milligrams per day and a 

concentration limit of 70 parts per 

million are being declared for this 

solvent. The analysis and 

recommendation are available for 

review on the Internet (see section V of 

this document on electronic access). 

The final recommendation is also 

available from the Division of Drug 

Information (see ADDRESSES). The 

Agency will revise the tables in the 

guidance ‘‘Q3C—Tables and List’’ to 

reflect the ICH final recommendation for 

cumene. 

The final recommendation for the 

solvent cumene is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The revised PDE for the solvent cumene 

contained in the revised guidance 

‘‘Q3C—Tables and List’’ represents the 

Agency’s current thinking on this topic. 

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. Identify comments with the 

docket number found in brackets in the 

heading of this document. The 

recommendation and 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 Q3C guidance 

documents at http:// 

www.regulations.gov, http:// 

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, or http:// 

www.fda.gov/;BiologicsBlood;Vaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm. 

Information on the Q3C maintenance 

process as well as proposals, data 

analysis, and draft and final 

recommendations for revisions to the 

tables and list are available at http:// 

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/ucm125820.htm. 

Dated: February 16, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4164 Filed 2–22–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Request for Nominations for Voting 

Members on a Public Advisory 

Committee; Risk Communication 

Advisory Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

nominations for members to serve on 

the Risk Communication Advisory 

Committee, Office of Planning, Office of 

Policy and Planning, Office of the 

Commissioner. 

FDA has a special interest in ensuring 

that women, minority groups, and 

individuals with disabilities are 

adequately represented on advisory 

committees and, therefore, encourages 

nominations of qualified candidates 

from these groups. 

DATES: Nominations received on or 

before April 23, 2012 will be given first 

consideration for membership on the 

Risk Communication Advisory 

Committee. Nominations received after 

April 23, 2012 will be considered for 

nomination to the committee as later 

vacancies occur. 

ADDRESSES: All nominations for 

membership should be sent 

electronically to cv@oc.fda.gov or by 

mail to the Advisory Committee 

Oversight and Management Staff, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, rm. 5103, 

Silver Spring, MD 20993–0002. 

FOR FURTHER INFORMATION CONTACT: 

Regarding all nomination questions for 

membership, the primary contact is: Lee 

L. Zwanziger, Risk Communication 

Staff, Office of Planning, Office of Policy 

and Planning, Office of the 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 301– 

796–9151, Fax: 301–847–8611, 

RCAC@FDA.HHS.GOV. 

Information about becoming a 

member on an FDA advisory committee 

can also be obtained by visiting FDA’s 

Web site by using the following link: 

http://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nomination for voting 

members on the Risk Communication 

Advisory Committee. 

I. General Description of the Committee 

Duties 

The Risk Communication Advisory 

Committee advises the Commissioner of 

Food and Drugs or designee on methods 

to effectively communicate risks 

associated with products regulated by 

the Food and Drug Administration and 

in discharging responsibilities as they 

relate to helping to ensure safe and 

effective drugs for human use and any 

other product for which the Food and 

Drug Administration has regulatory 

responsibility. 

The Committee reviews and evaluates 

strategies and programs designed to 

communicate with the public about the 

risks and benefits of FDA-regulated 

products so as to facilitate optimal use 

of these products. The Committee also 

reviews and evaluates research relevant 

to such communication to the public by 

both FDA and other entities. It also 

facilitates interactively sharing risk and 

benefit information with the public to 

enable people to make informed 

independent judgments about use of 

FDA-regulated products. 

II. Criteria for Voting Members 

The Committee consists of a core of 

15 voting members including the Chair. 

Members and the Chair are selected by 

the Commissioner or designee from 

among authorities knowledgeable in 

fields such as social marketing, health 

literacy, and other relevant areas. 

Members will include experts on risk 

communication, experts on emerging 

postmarket drug risks and individuals 

knowledgeable about and experienced 

in the work of patient, consumer, and 

health professional organizations. 

Almost all non-Federal members of this 

committee serve as Special Government 

Employees. Some members will be 

selected to provide experiential insight 

on the communication needs of the 

various groups who use FDA-regulated 

products. The latter may include 

patients and patients’ family members, 

health professionals, communicators in 

health, medicine and science, and 

persons affiliated with consumer, 

specific disease, or patient safety 

advocacy groups. Members will be 

invited to serve for terms of up to 4 

years. 

mstockstill on DSK4VPTVN1PROD with NOTICES

10756 Federal Register / Vol. 77, No. 36 / Thursday, February 23, 2012 / Notices 

III. Nomination Procedures 

Any interested person may nominate 

one or more qualified individuals for 

membership on the advisory committee. 

Self-nominations are also accepted. 

Nominations must include a current, 

complete re ́sume ́ or curriculum vitae for 

each nominee, including current 

business address and/or home address, 

telephone number, and email address if 

available. Nominations must also 

specify the advisory committee for 

which the nominee is recommended. 

Nominations must also acknowledge 

that the nominee is aware of the 

nomination unless self-nominated. FDA 

will ask potential candidates to provide 

detailed information concerning such 

matters related to financial holdings, 

employment, and research grants and/or 

contracts to permit evaluation of 

possible sources of conflicts of interest. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: February 16, 2012. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2012–4139 Filed 2–22–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Commission on Childhood 

Vaccines; Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Public Law 92–463), notice is hereby 

given of the following meeting: 

Name: Advisory Commission on 

Childhood Vaccines (ACCV). 

Dates and Times: March 8, 2012, 9 

a.m. to 5 p.m. EST. March 9, 2012, 9 

a.m. to 12:30 p.m. EST. 

Place: Parklawn Building (and via 

audio conference call), Conference 

Room 10–65, 5600 Fishers Lane, 

Rockville, MD 20857. 

The ACCV will meet on Thursday, 

March 8, from 9 a.m. to 5 p.m. (EST) 

and on Friday, March 9, from 9 a.m. to 

12:30 p.m. (EST). The public can join 

the meeting via audio conference call by 

dialing 1–800–369–3104 (on March 8 & 

9) and providing the following 

information: 

Leader’s Name: Dr. Geoffrey Evans. 

Password: ACCV. 

Agenda: The agenda items for the 

March meeting will include, but are not 

limited to: Updates from the Division of 

Vaccine Injury Compensation (DVIC), 

the Department of Justice, the National 

Vaccine Program Office, the 

Immunization Safety Office (Centers for 

Disease Control and Prevention), the 

National Institute of Allergy and 

Infectious Diseases (National Institutes 

of Health), and the Center for Biologics, 

Evaluation, and Research (Food and 

Drug Administration). A draft agenda 

and additional meeting materials will be 

posted on the ACCV Web site (http:// 

www.hrsa.gov/vaccinecompensation/ 

accv.htm) prior to the meeting. Agenda 

items are subject to change as priorities 

dictate. 

Public Comment: Persons interested 

in attending the meeting in person or 

providing an oral presentation should 

submit a written request, along with a 

copy of their presentation to: Annie 

Herzog, DVIC, Healthcare Systems 

Bureau (HSB), Health Resources and 

Services Administration (HRSA), Room 

11C–26, 5600 Fishers Lane, Rockville, 

Maryland 20857 or email: 

aherzog@hrsa.gov. Requests should 

contain the name, address, telephone 

number, email address, and any 

business or professional affiliation of 

the person desiring to make an oral 

presentation. Groups having similar 

interests are requested to combine their 

comments and present them through a 

single representative. The allocation of 

time may be adjusted to accommodate 

the level of expressed interest. DVIC 

will notify each presenter by email, mail 

or telephone of their assigned 

presentation time. Persons who do not 

file an advance request for a 

presentation, but desire to make an oral 

statement, may announce it at the time 

of the public comment period. Public 

participation and ability to comment 

will be limited to space and time as it 

permits. 

FOR FURTHER INFORMATION CONTACT: 

Anyone requiring additional 

information regarding the ACCV should 

contact Annie Herzog, DVIC, HSB, 

HRSA, Room 11C–26, 5600 Fishers 

Lane, Rockville, MD 20857; telephone 

(301) 443–6593; email: 

aherzog@hrsa.gov. 

Dated: February 15, 2012. 

Reva Harris, 

Acting Director, Division of Policy and 

Information Coordination. 

[FR Doc. 2012–4225 Filed 2–22–12; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Opinions and Perspectives 

About the Current Blood Donation 

Policy for Men Who Have Sex With 

Men 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Heart, Lung, and Blood 

Institute (NHLBI), the National 

Institutes of Health (NIH), will publish 

periodic summaries of proposed 

projects to the Office of Management 

and Budget (OMB) for review and 

approval. 

Proposed Collection: Title: Opinions 

and Perspectives about the Current 

Blood Donation Policy for Men Who 

Have Sex with Men. Type of 

Information Collection Request: New. 

Need and Use of Information Collection: 

The current policy for blood donation in 

the U.S. with respect to men who have 

sex with men (MSM) is that any man 

who discloses having had sex with 

another man since 1977 is deferred 

indefinitely from donating. However, 

data from donors who have tested 

disease marker positive and were 

interviewed regarding potential risk 

factors suggest that some individuals 

continue to donate blood without 

disclosing MSM activity in 

contravention of the policy. In the 1980s 

there were surveillance studies of risk 

factors among donors who were 

determined to be HIV positive in predonation testing: Results indicated 

MSM behavior to be a risk factor for 

56% of male donors. In addition, as part 

of the Retrovirus Epidemiology Donor 

Study (REDS), when anonymously 

surveyed by paper and pencil mailed 

surveys, 1.2% of male blood donors 

reported MSM behavior. 

In a 2007 study conducted in Sweden, 

19% of 334 MSM who responded to a 

survey that was included in a monthly 

publication targeted to the Lesbian, Gay, 

Bisexual and Transgender (LGBT) 

community reported donating blood at 

least one-time since 1985. The authors 

suggested that MSM donors may be 

motivated by perceived discrimination, 

particularly younger MSM. 

Recent publications from the United 

Kingdom have reported what are likely 

the only population-based assessment of 

non-compliance with a similar 

restriction on blood donation for the 

MSM population as in the U.S.; this 

mstockstill on DSK4VPTVN1PROD with NOTICES