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

Federal Register / Vol. 77, No. 36 / Thursday, February 23, 2012 / Notices 10757 

study was conducted in 2009 and 2010 

and also estimated opinions about and 

self-reported intended compliance with 

the MSM deferral policy in place in the 

United Kingdom at that time. Note, the 

policy in the United Kingdom was 

modified in November 2011 and MSM 

in the United Kingdom are now allowed 

to donate if they have not been sexually 

active for a one-year period before 

donation. 

Data similar to those collected in 

Sweden and the United Kingdom are 

not available for the U.S. Potential 

changes to the current MSM policy for 

blood donation requires additional data, 

including information about motivating 

factors and compliance with the current 

MSM policy or a modified policy in the 

MSM population and in current blood 

donors. Speculative analyses have been 

conducted but do not directly address 

important considerations related to this 

policy such as the current level of 

compliance (in the MSM population) 

and non-compliance (in the blood donor 

population). While many scientists and 

ethicists have expressed opinions in 

support or against modification of the 

current MSM policy for blood donation, 

there is a lack of data that directly 

addresses important aspects of this 

policy debate. The proposed study will 

build off the studies conducted in 

Sweden and the United Kingdom and 

will collect directly relevant 

information on this topic by estimating 

the prevalence of compliance and noncompliance with the current MSM 

policy and assessing motivations for 

blood donation in the U.S. MSM 

population. Three research aims drive 

this study’s protocols to provide 

valuable evidence on the motivations 

and compliance behaviors in the MSM 

and blood donor populations. The four 

geographic areas where the study will 

be conducted include the State of 

Connecticut, Western Pennsylvania, 

Southern Wisconsin, and the Bay Area 

of California. 

The first aim seeks to assess opinions 

about and common themes within the 

MSM population with respect to blood 

donation and the current MSM policy. 

Specifically, within a population of selfidentified MSM in the U.S., what 

common themes can be identified 

regarding knowledge and opinions of 

current blood donation eligibility, and 

would opinions, including self-reported 

intended compliance, improve if the 

current MSM policy were changed to a 

deferral of a defined shorter duration? 

Another objective is to use what is 

learned in the focus groups to help 

select proper venues for identifying 

MSM who might be interested in 

participating in a comprehensive survey 

to assess compliance and noncompliance with the current MSM 

policy (see second aim). 

The second aim seeks to assess 

compliance and non-compliance in the 

MSM population with the current MSM 

blood donation policy by confidentially 

surveying two populations. One survey 

will be conducted in the MSM 

community to provide better estimates 

of compliance and non-compliance with 

the current policy and a second survey 

will be conducted in male blood donors 

to evaluate how frequently men who 

have had sex with another man since 

1977 are donating blood. The surveys 

will be conducted using an instrument 

that includes common content to 

maximize the comparability of the 

responses. Both surveys will be 

conducted using Internet-based 

techniques and currently available 

software (SurveyGizmo, 

www.surveygizmo.com). 

The third aim seeks to assess 

motivations for donating in the group of 

self-identified MSM who are active 

blood donors in the U.S. Participants 

from the four geographic areas who 

report donating blood or the intention to 

donate will be asked to participate in 

confidential qualitative telephone 

interviews to identify their reasons for 

donating or wanting to donate blood. 

Frequency of Response: Once. 

Affected Public: Individuals. Type of 

Respondents: Males 18 years old or 

older. The annual reporting burden is as 

follows: Estimated Number of 

Respondents: 4864; Estimated Number 

of Responses per Respondent: 1 per 

respondent for 4844 respondents and 2 

per respondent for 20 respondents; 

Average Burden of Hours per Response: 

1.5 hours for Aim 1, 0.33 hour for Aim 

2, and 1.0 hour for Aim 3; and 

Estimated Total Annual Burden Hours 

Requested: 1,700. The annualized total 

cost to all respondents is estimated at: 

$13,600 (based on $8.00 per hour). 

There are no Capital Costs to report. 

There are no Operating or Maintenance 

Costs to report. 

Study Aims 

Estimated 

Annual Number 

of Respondents 

Estimated 

Number of 

Responses per 

Respondent 

Average Burden 

Hours per 

Response 

Estimated Total 

Annual Burden 

Hours Requested 

Aim 1—Focus Groups ................................................................... 64 1 1 .5 96 

Aim 2.1—Web interview ................................................................ 1,600 1 0 .33 528 

Aim 2.2—Web interview ................................................................ 3,200 1 0 .33 1056 

Aim 3 .............................................................................................. * 20 1 1 20 

* Aim 3 respondents are a subset of the respondents included in Aim 2. 

Request For Comments: Written 

comments and/or suggestions from the 

public and affected agencies should 

address one or more of the following 

points: (1) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

function of the agency, including 

whether the information will have 

practical utility; (2) The accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and the assumptions used; 

(3) Ways to enhance the quality, utility, 

and clarity of the information collected; 

and (4) Ways to minimize the burden of 

the collection of information on those 

who are to respond, including the use 

of appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact: Simone Glynn, 

MD, Project Officer/ICD Contact, Two 

Rockledge Center, Suite 9142, 6701 

Rockledge Drive, Bethesda, MD 20892, 

or call 301– 435–0065, or Email your 

request to: glynnsa@nhlbi.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

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10758 Federal Register / Vol. 77, No. 36 / Thursday, February 23, 2012 / Notices 

Dated: February 9, 2012. 

Keith Hoots, 

Director, Division of Blood Diseases and 

Resources, National Heart, Lung, and Blood 

Institute, NIH. 

Dated: February 13, 2012. 

Lynn Susulske, 

NHLBI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 2012–4211 Filed 2–22–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; Application for 

Collaboration With the NIH Center for 

Translational Therapeutics (NCTT) 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Center for Advancing Translational 

Sciences (NCATS), the National 

Institutes of Health (NIH) has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

listed below. This proposed information 

collection was previously published in 

the Federal Register on November 11, 

2011, page 69743–69744 and allowed 

60-days for public comment. No public 

comments were received. The purpose 

of this notice is to allow an additional 

30 days for public comment. The 

National Institutes of Health may not 

conduct or sponsor, and the respondent 

is not required to respond to, an 

information collection that has been 

extended, revised, or implemented on or 

after October 1, 1995, unless it displays 

a currently valid OMB control number. 

Proposed Collection: Title: 

Application for collaboration with the 

NIH Center for Translational 

Therapeutics (NCTT) . Type of 

Information Collection Request: New. 

Need and Use of Information Collection: 

Programs at the NCTT provide 

opportunities to partner with and gain 

access to both common and specifically 

rare and neglected disease through a 

variety of programs delivering assay 

development, screening, hit to lead 

chemistry, lead optimization, chemical 

biology studies, drug development 

capabilities, expertise, and clinical/ 

regulatory resources in a collaborative 

environment with the goal of moving 

promising therapeutics into human 

clinical trials. NCTT uses an application 

and evaluation process to select 

collaborators. Selected investigators 

provide the drug project starting points 

and ongoing biological/disease expertise 

throughout the project. Frequency of 

Response: Once per year. Affected 

Public: Research scientists. Type of 

Respondents: not-for-profits, for-profit, 

governmental. The annual reporting 

burden is as follows: Estimated Number 

of Respondents: 170. Estimated Number 

of Responses per Respondent: 1. 

Average Burden Hours Per Response: 1. 

Estimated Total Annual Burden Hours 

Requested: 510. 

ESTIMATES OF HOUR BURDEN

Forms Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

hours per 

response 

Total annual 

burden hours 

Online Collaborator Solicitation ....................................................... 170 1 1 170 

NCTT Project Information Template ................................................ 170 1 1 170 

Solicitation Instructions (TRND) ....................................................... 100 1 1 100 

Solicitation Instructions (BrIDGs) ..................................................... 70 1 1 70 

Total .......................................................................................... ............................ ............................ ............................ 510 

The annualized cost to respondents is 

estimated at: $21,261. Capital Costs are 

$0. Operating Cost is roughly $14,333 

for the database to accept and 

coordinate responses. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) The accuracy of the agency’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) Ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

Ways to minimize the burden of the 

collection of information on those who 

are to respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974, Attention: Desk 

Officer for NIH. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact: Dr. 

Helen Gift, Chief, Disease Prevention 

and Health Promotion Branch, DEODP, 

NIDCR, NIH, Natcher Building, Room 

3AN–44D, 9000 Rockville Pike, 

Bethesda, MD 20892, or call non-tollfree number 301–594–5579 or Email 

your request, including your address to: 

GiftH@de45.nidr.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30-days of the date of 

this publication. 

Dated: February 15, 2012. 

John McKew, 

Chief, Preclinical Development Branch, NIH 

Center for Translational Therapeutics, 

National Center for Advancing Translational 

Sciences, National Institutes of Health. 

[FR Doc. 2012–4212 Filed 2–22–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Child Health and 

Human Development Proposed 

Collection; Comment Request; NEXT 

Generation Health Study 

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 Institute of Child Health and 

mstockstill on DSK4VPTVN1PROD with NOTICES