67176 Federal Register / Vol. 79, No. 218 / Wednesday, November 12, 2014 / Notices 

CBER at http://www.fda.gov/Biologics

BloodVaccines/GuidanceCompliance

RegulatoryInformation/default.htm. 

Persons unable to download an 

electronic copy of ‘‘Molecular 

Diagnostic Instruments With Combined 

Functions’’ may send an email request 

to CDRH-Guidance@fda.hhs.gov to 

receive an electronic copy of the 

document. Please use the document 

number 1763 to identify the guidance 

you are requesting. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 807, subpart E, have been 

approved under OMB control number 

0910–0120; the collections of 

information in 21 CFR part 803 have 

been approved under OMB control 

number 0910–0437; and the collections 

of information in 21 CFR part 801 and 

21 CFR 809.10 have been approved 

under OMB control number 0910–0485. 

V. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). 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. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

Dated: November 5, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–26694 Filed 11–10–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request; HIV Study in Blood 

Donors From Five Chinese Regions 

(NHLBI) 

SUMMARY: Under the provisions of 

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

Reduction Act of 1995, 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 in Volume 79, June 

12, 2014 on page 33764 and allowed 60- 

days for public comment. One public 

comment was received that was a 

personal opinion regarding conducting 

research about the Chinese blood 

donation system. The purpose of this 

notice is to allow an additional 30 days 

for public comment. The National 

Institutes of Health (NIH) 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. 

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: NIH Desk Officer. 

Comment 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. 

FOR FURTHER INFORMATION CONTACT: To 

obtain a copy of the data collection 

plans and instruments or request more 

information on the proposed project 

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, 

including your address to: glynnsa@

nhlbi.nih.gov. Formal requests for 

additional plans and instruments must 

be requested in writing. 

Proposed Collection: HIV Study in 

Blood Donors From Five Chinese 

Regions, 0925–0596 Reinstatement With 

Change, National Heart, Lung and 

Blood Institute (NHLBI) 

Need and Use of Information 

Collection: This Study is a reinstatement 

with change of OMB Number: 0925– 

0596 expiration date, January 31, 2012. 

To better understand the diversifying 

and changing Human 

Immunodeficiency Virus (HIV) 

epidemic, and contemporary HIV risk 

factors, especially those associated with 

recent HIV infections, this HIV risk 

factor study in China is proposed as part 

of the Recipient Epidemiology and 

Donor Evaluation Study–III (REDS–III). 

The major objectives of the study will be 

to evaluate the proportion of blood 

donors in China who test positive for 

HIV and have acquired their infection 

recently or more remotely; the risk of 

releasing a blood product that contains 

HIV (HIV residual risk); and the risk 

factors associated with HIV infection in 

China. The study will also assess the 

frequency of distinct HIV–1 viral 

lineages and drug resistant mutations 

among HIV-positive blood donors. In 

2011, there were 780,000 people 

infected with HIV in China and it is 

estimated that over 300,000 HIV 

infected people in China are not aware 

of their infection status. The large 

migrating population and the 

complexity of HIV transmission routes 

in China make it difficult to implement 

a comprehensive and effective national 

HIV control strategy. Risk factors for 

infections can change over time; thus, 

identifying factors that contribute to the 

recent spread of HIV in a broad crosssection of an otherwise unselected 

general population, such as blood 

donors, is highly important for 

obtaining a complete picture of the 

epidemiology of HIV infection in China. 

Because the pace of globalization means 

infections can cross borders easily, the 

study objectives have direct relevance 

for HIV control in the US and globally. 

Recent years have seen an increase in 

blood donations from repeat donors in 

most Chinese regions. This increase 

permits longer-term follow-up and 

testing of repeat donors which allow for 

calculation of new HIV infection rates 

and residual risks. The HIV data, for 

both recently and remotely acquired 

infections, from the proposed study will 

complement existing data on HIV risks 

obtained from general and high risk 

populations to provide comprehensive 

HIV surveillance data for China. This 

study will also monitor genetic 

characteristics of recently acquired 

infections through genotyping and drug 

resistance testing, thus serving a US and 

global public health imperative to 

monitor the genotypes of HIV that have 

recently been transmitted. For HIV, the 

additional monitoring of drug resistance 

patterns in newly acquired infection is 

critical to determine if currently 

available antiretroviral medicines are 

capable of combating infection. 

Genotyping and host response 

information are scientifically important 

not only to China, but to the US and 

other nations since they provide a 

broader global understanding of how to 

most effectively manage and potentially 

prevent HIV, for example through 

vaccine development. Efforts to develop 

vaccines funded by the National 

Institutes of Health and other US-based 


TKELLEY on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 218 / Wednesday, November 12, 2014 / Notices 67177 

organizations may directly benefit from 

the findings of this study. 

Blood donors are tested for 

transfusion-transmissible infections 

including HIV when they present to 

donate, and test result information as 

well as demographic data will be 

routinely collected in a database at the 

five blood centers participating in 

REDS–III studies (located in the cities of 

Chongqing, Liuzhou, Luoyang, 

Mianyang, and Urumqi). These data will 

allow for calculation of HIV incidence, 

prevalence, and residual risk. 

Additionally, a case-control study will 

be conducted over a 2 and 1/2 year 

period to evaluate the risk factors 

associated with HIV infection among 

blood donors. Cases will be defined as 

potential donors who deny risks on the 

donor screening questionnaire but are 

found to be positive on HIV testing 

(their donation is discarded), HIVpositive donors who gave blood at one 

of the five blood centers as stated above 

(primary sites)or at blood centers 

located in the Guangxi Autonomous 

Region (peripheral sites, recruited 

through the Guangxi CDC for this study 

only but not other REDS–III studies) 

will be eligible to participate and 

complete a Risk Factor Questionnaire 

that will assess general demographic 

and risk factor information pertinent to 

HIV infection. Controls will be negative 

for HIV on confirmatory testing. 

Assuming 50% response rate, it is 

anticipated that 390 HIV-positive 

donors and 960 controls will participate 

in the case control study. The results of 

this study will contribute to global HIV 

surveillance and prevention, provide a 

broader global understanding of HIV 

epidemiology, and support public 

health efforts to most effectively manage 

and potentially prevent HIV 

transmission both worldwide and in the 

US. 

OMB approval is requested for 3 

years. There are no costs to respondents 

other than their time. The total 

estimated burden hours are 450. 

ESTIMATED ANNUALIZED BURDEN HOURS

Form name Type of respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total annual 

burden hours 

HIV Risk factor Q .............................. Blood donors—Case Primary Sites 210 1 20/60 70 

Blood donors—Case peripheral 

sites.

180 1 20/60 60 

Blood donors—Control primary sites 540 1 20/60 180 

Blood donors—Control peripheral 

sites.

420 1 20/60 140 

Dated: October 28, 2014. 

Lynn Susulske, 

NHLBI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 2014–26761 Filed 11–10–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

The National Institute of Mental Health 

(NIMH) Draft Strategic Plan; Request 

for Comments 

SUMMARY: NIMH is revising its 2008 

Strategic Plan to guide the Institute’s 

research efforts and priorities over the 

next five years (2015–2020). The 

purpose of this Notice is to seek input 

from the public about the draft NIMH 

2015 Strategic Plan. The draft plan will 

be publicly available through the NIMH 

Draft Strategic Plan Web page (http://

www.nimh.nih.gov/about/strategicplanning-reports/review-the-draft-2015- 

nimh-strategic-plan.shtml) for a 30-day 

period beginning on the publication 

date of this Notice. The public is invited 

to provide comments via the email 

address or postal address provided in 

this Notice and on the NIMH Draft 

Strategic Plan Web page. 

DATES: To ensure consideration, your 

responses must be received within a 30- 

day period that begins on the 

publication date of this Notice. 

ADDRESSES: Responses to this Notice 

should be submitted electronically 

using email to nimhstratplan@

mail.nih.gov. Alternatively, written 

responses can be submitted by mail to 

the Science Writing, Press, and 

Dissemination Branch, 6001 Executive 

Boulevard, Room 6200, MSC 9663. 

Bethesda, MD 20892–9663. 

FOR FURTHER INFORMATION CONTACT: 

Please contact our NIMH Information 

Specialists using the following contact 

information: telephone: 1–866–615– 

6464 (toll-free), 1–301–443–8431 (TTY), 

1–866–415–8051 (TTY toll-free). Fax: 1– 

301–443–4279, Email: nimhinfo@

nih.gov 

SUPPLEMENTARY INFORMATION: 

Background 

The National Institute of Mental 

Health (NIMH) is the lead federal 

agency for research on mental illnesses. 

The mission of the NIMH is to transform 

the understanding and treatment of 

mental illnesses through basic and 

clinical research, paving the way for 

prevention, recovery, and cure. To 

fulfill its mission, the NIMH supports 

and conducts research on mental 

illnesses and the underlying basic 

science of brain and behavior; supports 

the training of scientists to carry out 

basic and clinical mental health 

research; and, communicates with 

scientists, patients, providers, and the 

general public about the science of 

mental illnesses. 

In 2008, the NIMH published a 

Strategic Plan to accelerate progress in 

basic, translational, and clinical science. 

The need to update the plan became 

clear with the increasing number of 

remarkable scientific advancements and 

the changing landscape of mental health 

care over the past six years. With the 

goals of helping individuals living with 

mental illnesses and promoting both 

prevention and cure, NIMH has revised 

its original four high-level Strategic 

Objectives as follows: (1) Define the 

biological basis of complex behaviors; 

(2) chart mental illness trajectories to 

determine when, where, and how to 

intervene; (3) develop better preventive 

and therapeutic interventions; and, (4) 

strengthen the public health impact of 

NIMH-supported research. These four 

Strategic Objectives form a broad 

roadmap for the Institute’s priorities 

over the next five years, which begins 

with the fundamental science of the 

brain and behavior, and ends with 

public health impact. Full 

implementation of these Strategies 

Objectives, will, we hope, transform the 


TKELLEY on DSK3SPTVN1PROD with NOTICES