61646 Federal Register / Vol. 79, No. 198 / Tuesday, October 14, 2014 / Notices 

sites after this document is published in 

the Federal Register.) Payment by major 

credit card is accepted (Visa/

MasterCard/AMEX only). For more 

information on the meeting registration, 

or for questions on the workshop, 

contact SoCRA (see Contact). 

SUPPLEMENTARY INFORMATION: The 

public workshop helps fulfill the 

Department of Health and Human 

Services’ and FDA’s important mission 

to protect the public health. The public 

workshop will provide those engaged in 

FDA-regulated (human) clinical trials 

with information on a number of topics 

concerning FDA requirements related 

informed consent, clinical investigation 

requirements, institutional review board 

inspections, electronic record 

requirements, and investigator initiated 

research Topics for discussion include 

the following: (1) The Role of the FDA 

District Office Relative to the 

Bioresearch Monitoring Program 

(BIMO); (2) Modernizing FDA’s Clinical 

Trials/BIMO Programs; (3) What FDA 

Expects in a Pharmaceutical Clinical 

Trial; (4) Medical Device Aspects of 

Clinical Research; (5) Adverse Event 

Reporting—Science, Regulation, Error, 

and Safety; (6) Working with FDA’s 

Center for Biologics Evaluation and 

Research; (7) Ethical Issues in Subject 

Enrollment; (8) Keeping Informed and 

Working Together; (9) FDA Conduct of 

Clinical Investigator Inspections; (10) 

Investigator Initiated Research; (11) 

Meetings with FDA—Why, When, and 

How; (12) Part 11 Compliance— 

Electronic Signatures; (13) IRB 

Regulations and FDA Inspections; (14) 

Informed Consent Regulations; (15) The 

Inspection is Over—What Happens 

Next? Possible FDA Compliance 

Actions; (16) Question and Answer 

Session/Panel Discussion. 

FDA has made education of the drug 

and device manufacturing community a 

high priority to help ensure the quality 

of FDA-regulated drugs and devices. 

The public workshop helps to achieve 

objectives set forth in section 406 of the 

FDA Modernization Act of 1997 (21 

U.S.C. 393), which includes working 

closely with stakeholders and 

maximizing the availability and clarity 

of information to stakeholders and the 

public. The workshop also is consistent 

with the Small Business Regulatory 

Enforcement Fairness Act of 1996 (Pub. 

L. 104–121), as outreach activities by 

Government agencies to small 

businesses. 

Dated: October 7, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–24307 Filed 10–10–14; 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; Evaluation of 

National Institutes of Health 

International Bilateral Programs (FIC, 

NCI, NIAAA, NIAID, NICHD, NIDA, 

NINDS, NIMH, OAR) 

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 on March 13, 2014 

(Vol. 79, P. 14256) 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 Cancer Institute (NCI), 

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. 

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. 

DATES: 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: Margaret Mary Bertram, Center 

for Global Health, National Cancer 

Institute, 9609 Medical Center Dr., Rm 

3W264, Rockville MD, 20850 or call 

non-toll-free number 240–276–5656 or 

Email your request, including your 

address to: margaret.bertram@nih.gov. 

Formal requests for additional plans and 

instruments must be requested in 

writing. 

Proposed Collection: Evaluation of 

National Institutes of Health 

International Bilateral Programs (FIC, 

NCI, NIAAA, NIAID, NICHD, NIDA, 

NINDS, NIMH, OAR), 0925–NEW, 

National Cancer Institute (NCI), 

National Institutes of Health (NIH). 

Need and Use of Information 

Collection: This submission is a request 

for OMB to approve the Evaluation of 

National Institutes of Health (NIH) 

International Bilateral Programs for 

three years. The bilateral awards are 

made through the Funding Opportunity 

Announcement mechanism and 

administrative supplements, meaning 

they are funded by set-aside funds that 

are separate from the general pool of 

research program grant funds used to 

support investigator initiated research at 

NIH. The bilateral programs to be 

evaluated are the U.S.-China Program 

for Biomedical Research Cooperation, 

U.S.-India Bilateral Collaborative 

Research Partnerships on the Prevention 

of HIV/AIDS and Co-morbidities, U.S.- 

Russia Bilateral Collaborative Research 

Partnerships on the Prevention and 

Treatment of HIV/AIDS and Comorbidities, and U.S.-South Africa 

Program for Collaborative Biomedical 

Research. These programs are funded 

and administered by various 

combinations of the following institutes: 

Fogarty International Center (FIC), the 

Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development (NICHD), National Cancer 

Institute (NCI), National Institute on 

Alcohol Abuse and Alcoholism 

(NIAAA), National Institute for Allergy 

and Infectious Diseases (NIAID), 

National Institute on Drug Abuse 

(NIDA), National Institute of Mental 

Health (NIMH), National Institute of 

Neurological Disorders and Stroke 

(NINDS), and the Office of AIDS 

Research (OAR). While these programs 

differ, their underlying concept is the 

same; they require U.S. scientists to 

collaborate with scientists from other 

countries in order to conduct 

scientifically meritorious investigations 

of mutual interest to both countries. The 

proposed evaluation requests 

information about (1) accomplishments 

of the awards, (2) unique findings or 

opportunities due to the international 

collaborations, and (3) successes and 

challenges of these collaborations. The 

information will be collected one year 

into the award and at the end of the 

award, when possible. This information 

is needed to evaluate the effectiveness 

of these programs across NIH. 

OMB approval is requested for 3 

years. There are no costs to respondents 

other than their time. The total 

estimated annualized burden hours are 

129. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 79, No. 198 / Tuesday, October 14, 2014 / Notices 61647 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Forms Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total annual 

burden hours 

Principal Investigators ................. Administrative Supplements ................... 24 1 1 24 

Year 1 Survey ........................................ 52 1 1 52 

Final Year Survey .................................. 52 1 1 52 

Telephone Script for Non-Responders .. 16 1 3/60 1 

Dated: October 6, 2014. 

Karla Bailey, 

NCI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 2014–24437 Filed 10–10–14; 8:45 am] 

BILLING CODE 4140–01–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 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR:392: 

New Computational Methods for 

Understanding the Functional Role of DNA 

Variants that are Associated with Mental 

Disorder. 

Date: October 29, 2014. 

Time: 12:00 p.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Alexander Gubin, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6046B, 

MSC 7892, Bethesda, MD 20892, 301–408– 

9655, gubina@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Vascular 

Biology and Hematology AREA. 

Date: November 6, 2014. 

Time: 2:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Larry Pinkus, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4132, 

MSC 7802, Bethesda, MD 20892, (301) 435– 

1214, pinkusl@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Child Psychopathology and 

Developmental Disabilities. 

Date: November 10–11, 2014. 

Time: 8:00 a.m. to 11:59 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Mark Lindner, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3182, 

MSC 7770, Bethesda, MD 20892, 301–435– 

0913, mark.lindner@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Mechanisms of Emotion, Stress and 

Health. 

Date: November 10–11, 2014. 

Time: 8:00 a.m. to 11:59 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Mark Lindner, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3182, 

MSC 7770, Bethesda, MD 20892, 301–435– 

0913, mark.lindner@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Bacterial Biochemistry, Genetics, 

and Evolution. 

Date: November 10, 2014. 

Time: 2:30 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Barbara J. Thomas, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2218, 

MSC 7890, Bethesda, MD 20892, 301–435– 

0603, bthomas@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: Non-HIV Anti-Infective 

Therapeutics. 

Date: November 12, 2014. 

Time: 8:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Residence Inn Alexandria Old 

Town, 1456 Duke Street, Alexandria, VA 

22314. 

Contact Person: Kenneth M. Izumi, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge, Rm 3204, MSC 7808, 

Bethesda, MD 20892, 301–496–6980, 

izumikm@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; AREA 

Application Review. 

Date: November 12, 2014. 

Time: 9:30 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

Contact Person: Liangbiao Zheng, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3202, 

MSC 7808, Bethesda, MD 20892, 301–996– 

5819, zhengli@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Cell Biology. 

Date: November 12, 2014. 

Time: 10:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Wallace Ip, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5128, 

MSC 7840, Bethesda, MD 20892, 301–435– 

1191, ipws@mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Imaging and 

Biomarkers for Early Cancer Detection: 

PAR13–189. 

Date: November 12, 2014. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

Contact Person: Chiayeng Wang, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, 6701 Rockledge Drive, 

Room 5213, MSC 7852, Bethesda, MD 20892, 

301–435–2397, chiayeng.wang@nih.gov. 

mstockstill on DSK4VPTVN1PROD with NOTICES