40160 Federal Register / Vol. 82, No. 163 / Thursday, August 24, 2017 / Notices 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–D–1956 for ‘‘Identifying Trading 

Partners Under the Drug Supply Chain 

Security Act; Draft Guidance for 

Industry; Availability.’’ 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 draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; or 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 that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Mannion, Office of Compliance, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–3130, drugtrackandtrace@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Identifying Trading Partners Under the 

Drug Supply Chain Security Act.’’ The 

DSCSA (Title II of Pub. L. 113–54) 

establishes new requirements to develop 

and enhance drug distribution security 

by 2023. It does this, in part, by defining 

different types of entities in the drug 

supply chain as trading partners (i.e., 

manufacturers, repackagers, wholesale 

distributors, third-party logistics 

providers, and dispensers). Among 

other things, the DSCSA requires that 

trading partners of manufacturers, 

wholesale distributors, dispensers, and 

repackagers must meet the applicable 

requirements for being ‘‘authorized 

trading partners.’’ In addition, the 

DSCSA outlines requirements for 

specific trading partners, including drug 

product tracing and licensure 

requirements. FDA has received 

questions about which types of entities 

are included in each of the trading 

partner definitions and this guidance is 

intended to help clarify and explain the 

relevant statutory provisions. The 

guidance covers who is considered to be 

a manufacturer, a repackager, a 

wholesale drug distributor, a third-party 

logistics provider, and a dispenser for 

purposes of certain DSCSA 

requirements. 

II. Additional Issues for Consideration: 

Specific Request for Comments and 

Information 

In addition to comments on the draft 

guidance generally, FDA is requesting 

comments specifically related to the 

activities of private-label distributors 

(PLDs), and whether those activities fall 

within the definitions under DSCSA of 

the various trading partners. FDA 

considers a PLD to be an entity that 

owns and distributes a manufactured 

product under its own label or trade 

name. Because there are many different 

business models for PLDs, resulting in 

situations where a PLD could be 

considered a manufacturer, wholesale 

distributor, or dispenser, we are asking 

for comments on how the different 

business models might impact a PLD’s 

status as an authorized trading partner 

under the DSCSA. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices (see 21 CFR 10.115). The draft 

guidance, when finalized, will represent 

the current thinking of FDA on 

‘‘Identifying Trading Partners under the 

Drug Supply Chain Security Act.’’ 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. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

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

ComplianceRegulatoryInformation/ 

Guidances/default.htm, http://

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm, or 

https://www.regulations.gov. 

Dated: August 18, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–17919 Filed 8–21–17; 11:15 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Notice of Supplemental Awards to the 

Territorial Health Departments of 

Puerto Rico, American Samoa, and 

U.S. Virgin Islands for the Zika 

Maternal and Child Health Services 

Program 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 


rmajette on DSKBCKNHB2PROD with NOTICES
Federal Register / Vol. 82, No. 163 / Thursday, August 24, 2017 / Notices 40161 

ACTION: Notice of Supplemental Award. 

SUMMARY: HRSA announces the award 

of supplemental grants under the Zika 

Response and Preparedness Act to the 

territorial health departments of Puerto 

Rico, American Samoa, and U.S. Virgin 

Islands to address the unmet needs of 

women, children, and families who are 

or may be affected by Zika virus (ZIKV) 

infection. 

SUPPLEMENTARY INFORMATION: 

Intended Recipient of the Award: 

Territorial health departments of Puerto 

Rico, American Samoa, and U.S. Virgin 

Islands. 

Amount of Non-Competitive Awards: 

Approximately $1,050,000. 

CFDA Number: 93.110. 

Authority: Zika Response and 

Preparedness Act (Pub. L. 114–223) and 

Section 501(a)(2) of the Social Security 

Act (42 U.S.C. 701(a)(2)). 

Justification: The current spread of 

ZIKV poses a significant threat to public 

health, including the health of women, 

children, and families who are affected 

by ZIKV infection. ZIKV infection 

during pregnancy can cause serious 

birth defects, especially affecting the 

neurological system of the infant. 

Funding for these awards is available 

under the Zika Response and 

Preparedness Act through Special 

Projects of Regional and National 

Significance (SPRANS) funds. 

The needs of infants and children 

affected by ZIKV are complex. Families, 

health care providers, and public health 

professionals will be required to work 

together to assure that communitybased, comprehensive, high quality 

health and social services are available 

to these children. The support system 

must address the medical needs of these 

children, such as regularly screening 

children who may not be symptomatic 

at birth; coordinate care through a 

medical home; finance care needed by 

children and families; link to 

community-based services; partner with 

families; and eventually address 

transition to adult services. Following 

HRSA’s December 2016 grant awards to 

the territorial health departments of 

Puerto Rico, American Samoa, and U.S. 

Virgin Islands, recipients continued to 

identify pregnant women and infants 

with lab evidence of ZIKV infection that 

led them to refine their response to 

ZIKV. HRSA’s Maternal and Child 

Health Bureau (MCHB) received 

information from the territorial health 

departments of unmet needs in their 

response to ZIKV through monitoring 

site visits, regular communication, and 

prior approval requests. Needs 

identified by recipients included 

additional equipment, personnel, and 

transportation services. With further 

analysis of other federal funding and the 

current epidemiologic data, MCHB 

confirmed additional funding is 

essential to ensure access to services 

and a comprehensive medical home for 

women, children, and families who are 

or may be affected by ZIKV infection. 

Disease burden and the significant 

increase in pregnant women and 

children with lab evidence of ZIKV 

infection in American Samoa and the 

U.S. Virgin Islands was also considered 

as a factor in determining the allocation 

of funds to the territories to address 

unmet needs. The period of 

performance of the supplemental award 

will be September 2017 through 

December 2019. 

FOR FURTHER INFORMATION CONTACT: 

Maria Paz Carlos, Division of State and 

Community Health, Maternal and Child 

Health Bureau, Health Resources and 

Services Administration, 5600 Fishers 

Lane, Room 18N104A, Rockville, 

Maryland 20857; MCarlos@hrsa.gov. 

Grantee/organization name Territory 

FY 2017 

supplemental 

awards 

Puerto Rico Health Department ................................................................ Puerto Rico .................................................................. $52,850 

American Samoa Health Department ....................................................... American Samoa ......................................................... 423,142 

U.S. Virgin Islands Health Department ..................................................... U.S. Virgin Islands ....................................................... 574,008 

Dated: August 18, 2017. 

George Sigounas, 

Administrator. 

[FR Doc. 2017–17883 Filed 8–23–17; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval: Public Comment 

Request; Information Collection 

Request Title: Federal Tort Claims Act 

(FTCA) Program Deeming Applications 

for Health Center Volunteer Health 

Professionals, OMB No. 0906–XXXX, 

New 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR must be 

received no later than September 25, 

2017. 

ADDRESSES: Submit your comments, 

including the ICR Title, to the desk 

officer for HRSA, either by email to 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–5806. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email the 

HRSA Information Collection Clearance 

Officer at paperwork@hrsa.gov or call 

(301) 443–1984. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference, in compliance with Section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995. 

Information Collection Request Title: 

Federal Tort Claims Act (FTCA) 

Program Deeming Applications for 

Health Center Volunteer Health 

Professionals OMB No. 0906–XXXX— 

New. 

Abstract: Section 224(q) of the Public 

Health Service (PHS) Act (42 U.S.C. 

233(q)), as amended, authorizes the 

‘‘deeming’’ of certain individuals as 

PHS employees for the purposes of 

receiving Federal Tort Claims Act 

(FTCA) coverage. Section 224(q) relates 

to volunteer health professionals (VHPs) 

of Health Center Program grantees that 

have been deemed as PHS employees. 

The Health Center FTCA Program is 

administered by HRSA’s Bureau of 

Primary Health Care (BPHC). 

Sponsoring health centers are required 


rmajette on DSKBCKNHB2PROD with NOTICES