52060 Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices 

II. Paperwork Reduction Act of 1995 

This draft guidance refers to 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 314.50 have 

been approved under OMB control 

number 0910–0001; the collections of 

information in 21 CFR 314.70 have been 

approved under OMB control number 

0910–0001; the collections of 

information in 21 CFR 201.57 have been 

approved under OMB control number 

0910–0572; the collections of 

information in 21 CFR 314.420 have 

been approved under OMB control 

number 0910–0001; and the collections 

of information in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https://

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm or 

https://www.regulations.gov. 

Dated: November 2, 2017. 

Lauren Silvis, 

Chief of Staff. 

[FR Doc. 2017–24353 Filed 11–8–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–6358] 

Blood Products Advisory Committee 

Advisory Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Blood Products Advisory 

Committee (the Committee). The general 

function of the committee is to provide 

advice and recommendations to the 

Agency on FDA’s regulatory issues 

related to blood and products derived 

from blood. The meeting will be open to 

the public. 

DATES: The meeting will be held on 

November 30, 2017, from 8 a.m. to 5:45 

p.m. and on December 1, 2017, from 8 

a.m. to 3:30 p.m. 

ADDRESSES: FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room 

(Rm. 1503), Silver Spring, MD, 20993– 

0002. Answers to commonly asked 

questions including information 

regarding special accommodations due 

to a disability, visitor parking, and 

transportation may be accessed at: 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm408555.htm. 

FOR FURTHER INFORMATION CONTACT: 

Bryan Emery or Joanne Lipkind, Center 

for Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Avenue, Silver Spring, 

MD 20993–0002, Bldg. 71, Rm. 6132, at 

240–402–8054, bryan.emery@

fda.hhs.gov and 240–402–8106, 

joanne.lipkind@fda.hhs.gov 

respectively, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before coming to the 

meeting. For those unable to attend in 

person, the meeting will also be 

available via Webcast. The Webcast will 

be available at the following link for 

both days: https://collaboration.fda.gov/ 

bpac2017. 

SUPPLEMENTARY INFORMATION: 

Agenda: On November 30, 2017, the 

Committee members will meet in open 

session to discuss bacterial risk control 

strategies for blood collection 

establishments and transfusion services 

to enhance the safety and availability of 

platelets for transfusion. In the 

afternoon, the Committee will be seated 

as a device classification panel. In open 

session, the panel will discuss the 

appropriate device classification of 

human leukocyte antigen, human 

platelet antigen, and human neutrophil 

antigen devices. On December 1, 2017, 

the committee members will meet in 

open session to discuss strategies to 

reduce the risk of transfusiontransmitted Zika virus. In the afternoon, 

an information session on the 

Transfusion Transmissible Infections 

Monitoring System will be presented to 

the Committee. Finally, the Committee 

will hear an update presentation on the 

April 6, 2017, FDA public workshop on 

emerging tick-borne diseases and blood 

safety. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before November 22, 2017. 

Oral presentations from the public will 

be scheduled between approximately 

11:35 a.m. to 12:20 p.m. and 4:15 p.m. 

to 4:45 p.m. on November 30, 2017. Oral 

presentations from the public will also 

be scheduled between approximately 

10:45 a.m. and 11:30 a.m. and 3 p.m. to 

3:30 p.m. on December 1, 2017. Those 

individuals interested in making formal 

oral presentations should notify the 

contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before November 14, 2017. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

November 15, 2017. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Bryan Emery 

or Joanne Lipkind at least 7 days in 

advance of the meeting. 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices 52061 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: November 6, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–24408 Filed 11–8–17; 8:45 am] 

BILLING CODE 4164–01–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, 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; National 

Centers for Cryo-Electron Microscopy-B. 

Date: November 30, 2017. 

Time: 2:00 p.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: William A. Greenberg, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4168, 

MSC 7806, Bethesda, MD 20892, (301) 435– 

1726, greenbergwa@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR–16– 

433: Support of NIGMS Program Project 

Grants. 

Date: December 1, 2017. 

Time: 1:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Kenneth A. Roebuck, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5106, 

MSC 7852, Bethesda, MD 20892, (301) 435– 

1166, roebuckk@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Vascular 

and Hematology AREA Application Review. 

Date: December 5, 2017. 

Time: 2:00 p.m. to 6:00 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: Natalia Komissarova, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5207, 

MSC 7846, Bethesda, MD 20892, 301–435– 

1206, komissar@mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR–15– 

053: Exploratory Grant Award in Basic 

Cancer Research (R21). 

Date: December 6, 2017. 

Time: 11:00 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 

(Virtual Meeting). 

Contact Person: Craig Giroux, Ph.D., 

Scientific Review Officer, BST IRG, Center 

for Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5150, 

Bethesda, MD 20892, 301–435–2204, 

girouxcn@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Cardiovascular Sciences. 

Date: December 7, 2017. 

Time: 1:00 p.m. to 2:30 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: Yuanna Cheng, MD, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4138, 

MSC 7814, Bethesda, MD 20892, (301) 435– 

1195, Chengy5@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR Panel: 

Serious Adverse Drug Reaction Review. 

Date: December 8, 2017. 

Time: 10:00 a.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Alexander D. Politis, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3210, 

MSC 7808, Bethesda, MD 20892, (301) 435– 

1150, politisa@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Emotion, Substance Use and 

Psychopathology. 

Date: December 8, 2017. 

Time: 1:00 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: Maribeth Champoux, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3170, 

MSC 7848, Bethesda, MD 20892, 301–594– 

3163, champoum@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Cancer Biology. 

Date: December 8, 2017. 

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 

(Virtual Meeting). 

Contact Person: Juraj Bies, Ph.D., Scientific 

Review Officer, Center for Scientific Review, 

National Institutes of Health, 6701 Rockledge 

Drive, Rm. 4158, MSC 7806, Bethesda, MD 

20892, 301 435 1256, biesj@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: November 3, 2017. 

Anna Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–24372 Filed 11–8–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Eye Institute; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting 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: National Eye Institute 

Special Emphasis Panel; NEI Cooperative 

Agreement Applications and Clinical 

Networks I. 

Date: November 27, 2017. 


sradovich on DSK3GMQ082PROD with NOTICES