42350 Federal Register / Vol. 82, No. 172 / Thursday, September 7, 2017 / Notices 

1271; Guidance for Industry.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

Submit written requests for single 

copies of the guidance to the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist the office in processing your 

requests. The guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–8010. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Tami Belouin, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a document entitled ‘‘Deviation 

Reporting for Human Cells, Tissues, and 

Cellular and Tissue-Based Products 

Regulated Solely Under Section 361 of 

the Public Health Service Act and 21 

CFR part 1271; Guidance for Industry.’’ 

The document provides establishments 

that manufacture HCT/Ps, regulated 

solely under section 361 of the PHS Act 

and the regulations under 21 CFR part 

1271, with recommendations and 

relevant examples for complying with 

the requirements under 21 CFR 

1271.350(b) to investigate and report 

HCT/P deviations. The examples 

provided in the guidance are intended 

to illustrate those HCT/P deviations that 

have been most frequently reported to 

FDA, CBER. 

The guidance does not apply to 

reproductive HCT/Ps or to HCT/Ps 

regulated under 21 CFR part 1270 and 

recovered before May 25, 2005. The 

guidance does not apply to healthcare 

professionals who implant, transplant, 

infuse, or transfer HCT/Ps into 

recipients. The guidance also does not 

apply to HCT/Ps that are regulated as 

drugs, devices, and/or biological 

products under section 351 of the PHS 

Act and/or the Federal Food, Drug, and 

Cosmetic Act, nor does it apply to 

investigational HCT/Ps subject to an 

investigational new drug application or 

an investigational device exemption. 

In the Federal Register of December 

24, 2015 (80 FR 80364), FDA announced 

the availability of the draft guidance of 

the same title dated December 2015. 

FDA received a few comments on the 

draft guidance and those comments 

were considered as the guidance was 

finalized. A summary of changes 

includes additional examples and 

editorial changes to improve clarity. The 

guidance announced in this notice 

finalizes the draft guidance dated 

December 2015. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Deviation 

Reporting for Human Cells, Tissues, and 

Cellular and Tissue-Based Products 

Regulated Solely Under section 361 of 

the Public Health Service Act and 21 

CFR part 1271.’’ It does not establish 

any rights for any person and is not 

binding on FDA or the public. You can 

use an alternative approach if it satisfies 

the requirements of the applicable 

statutes and regulations. This guidance 

is not subject to Executive Order 12866. 

II. 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 1271 have been approved 

under OMB control number 0910–0543. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either 

https://www.fda.gov/

BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/Guidances/default.htm or 

https://www.regulations.gov. 

Dated: August 23, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–18737 Filed 9–6–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Notice of Listing of Members of the 

National Institutes of Health’s Senior 

Executive Service 2017 Performance 

Review Board (PRB) 

SUMMARY: The National Institutes of 

Health (NIH) announces the persons 

who will serve on the National 

Institutes of Health’s Senior Executive 

Service 2017 Performance Review 

Board. 

FOR FURTHER INFORMATION CONTACT: For 

further information about the NIH 

Performance Review Board, contact the 

Office of Human Resources, Division of 

Senior and Scientific Executive 

Management, National Institutes of 

Health, Building 2, Room 5E18, 

Bethesda, Maryland 20892, telephone 

301–402–7999 (not a toll-free number). 

SUPPLEMENTARY INFORMATION: This 

action is being taken in accordance with 

Title 5, U.S.C., Section 4314(c)(4), 

which requires that members of 

performance review boards be 

appointed in a manner to ensure 

mstockstill on DSK30JT082PROD with NOTICES

Federal Register / Vol. 82, No. 172 / Thursday, September 7, 2017 / Notices 42351 

consistency, stability, and objectivity in 

performance appraisals and requires 

that notice of the appointment of an 

individual to serve as a member be 

published in the Federal Register. 

The following persons will serve on 

the NIH Performance Review Board, 

which oversees the evaluation of 

performance appraisals of NIH Senior 

Executive Service (SES) members: 

Alfred Johnson, Chair 

Joellen Austin 

Michael Gottesman 

Richard Ikeda 

Michael Lauer 

Ellen Rolfes 

LaVerne Stringfield 

Lawrence Tabak 

Timothy Wheeles 

Dated: August 30, 2017. 

Francis S. Collins, 

Director, National Institutes of Health. 

[FR Doc. 2017–18899 Filed 9–6–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Complementary 

and Integrative Health; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the National Advisory 

Council for Complementary and 

Integrative Health. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the 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 Advisory 

Council for Complementary and Integrative 

Health 

Date: October 6, 2017 

Closed: 8:30 a.m. to 9:45 a.m. 

Agenda: To review and evaluate grant 

applications 

Place: National Institutes of Health, 

Building 31, Conference Room 10, 31 Center 

Drive, Bethesda, MD 20892. 

Open: 10:00 a.m. to 3:00 p.m. 

Agenda: A report from the Institute 

Director and other staff. 

Place: National Institutes of Health, 

Building 31, Conference Room 10, 31 Center 

Drive, Bethesda, MD 20892. 

Contact Person: Partap Singh Khalsa, 

Ph.D., DC, Director, Division of Extramural 

Activities, National Center for 

Complementary and Integrative Health, NIH, 

National Institutes of Health, 6707 

Democracy Blvd., Ste. 401, Bethesda, MD 

20892–5475, (301) 594–3462, khalsap@

mail.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

Information is also available on the 

Institute’s/Center’s home page: https://

nccih.nih.gov/about/naccih/, where an 

agenda and any additional information for 

the meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.213, Research and Training 

in Complementary and Integrative Health, 

National Institutes of Health, HHS) 

Dated: August 31, 2017. 

Michelle Trout, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–18897 Filed 9–6–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

[CBP Dec. 17–11] 

Western Hemisphere Travel Initiative: 

Designation of an Approved Native 

American Tribal Card Issued by the 

Pokagon Band of Potawatomi Indians 

as an Acceptable Document To Denote 

Identity and Citizenship for Entry in the 

United States at Land and Sea Ports of 

Entry 

AGENCY: U.S. Customs and Border 

Protection; DHS. 

ACTION: Notice. 

SUMMARY: This notice announces that 

the Commissioner of U.S. Customs and 

Border Protection is designating an 

approved Native American Tribal Card 

issued by the Pokagon Band of 

Potawatomi Indians (Pokagon Band) to 

U.S. and Canadian citizens as an 

acceptable travel document for purposes 

of the Western Hemisphere Travel 

Initiative. The approved card may be 

used to denote identity and citizenship 

of Pokagon Band members entering the 

United States from contiguous territory 

or adjacent islands at land and sea ports 

of entry. 

DATES: This designation will become 

effective on September 7, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Colleen Manaher, Executive Director, 

Planning, Program Analysis, and 

Evaluation, Office of Field Operations, 

U.S. Customs and Border Protection, via 

email at Colleen.M.Manaher@

cbp.dhs.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

The Western Hemisphere Travel 

Initiative 

Section 7209 of the Intelligence 

Reform and Terrorism Prevention Act of 

2004 (IRTPA), Public Law 108–458, as 

amended, required the Secretary of 

Homeland Security (Secretary), in 

consultation with the Secretary of State, 

to develop and implement a plan to 

require U.S. citizens and individuals for 

whom documentation requirements 

have previously been waived under 

section 212(d)(4)(B) of the Immigration 

and Nationality Act (8 U.S.C. 

1182(d)(4)(B)) to present a passport or 

other document or combination of 

documents as the Secretary deems 

sufficient to denote identity and 

citizenship for all travel into the United 

States. See 8 U.S.C. 1185 note. On April 

3, 2008, the Department of Homeland 

Security (DHS) and the Department of 

State promulgated a joint final rule, 

effective on June 1, 2009, that 

implemented the plan known as the 

Western Hemisphere Travel Initiative 

(WHTI) at U.S. land and sea ports of 

entry. See 73 FR 18384 (the WHTI Land 

and Sea Final Rule). It amended various 

sections of the Code of Federal 

Regulations (CFR), including 8 CFR 

212.0, 212.1, and 235.1. The WHTI Land 

and Sea Final Rule specifies the 

documents that U.S. citizens and 

nonimmigrant aliens from Canada, 

Bermuda, and Mexico are required to 

present when entering the United States 

at land and sea ports of entry. 

Under the WHTI Land and Sea Final 

Rule, one type of citizenship and 

identity document that may be 

presented upon entry to the United 

mstockstill on DSK30JT082PROD with NOTICES