Federal Register / Vol. 82, No. 163 / Thursday, August 24, 2017 / Notices 40159 

Bureau (CB) is responsible for 

administering the review of eligible 

grant applications submitted in 

response to funding opportunity 

announcements issued by CB. CB 

ensures that the objective review 

process is independent, efficient, 

effective, economical, and complies 

with the applicable statutes, regulations, 

and policies. Applications are reviewed 

by subject experts knowledgeable in 

child welfare and related fields. Review 

findings are advisory to CB; CB is 

responsible for making award decisions. 

This announcement is a request for 

continued approval of the information 

collection system, the Reviewer 

Recruitment Module (RRM). CB uses a 

web-based data collection form and 

database to gather critical reviewer 

information in drop down menu format 

for data such as: Degree, occupation, 

affiliations with organizations and 

institutions that serve special 

populations, and demographic 

information that may be voluntarily 

provided by a potential reviewer. 

These data elements help CB find and 

select expert grant reviewers for 

objective review committees. The webbased system permits reviewers to 

access and update their information at 

will and as needed. The RRM is 

accessible by the general public via 

https://rrm.grantsolutions.gov/ 

AgencyPortal/cb.aspx. 

Respondents: Generally, our 

reviewers are current or retired 

professionals with backgrounds in child 

welfare and related fields and in some 

instances current or former foster care 

parents or clients. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Reviewer Recruitment Module ......................................................................... 500 1 .25 125 

Estimated Total Annual Burden 

Hours: 125. 

In compliance with the requirements 

of the Paperwork Reduction Act of 1995 

(Pub. L. 104–13, 44 U.S.C. Chap 35), the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 330 C Street SW., 

Washington DC 20201. Attn: ACF 

Reports Clearance Officer. Email 

address: infocollection@acf.hhs.gov. All 

requests should be identified by the title 

of the information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2017–17935 Filed 8–23–17; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–1956] 

Identifying Trading Partners Under the 

Drug Supply Chain Security Act; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Identifying Trading Partners Under the 

Drug Supply Chain Security Act’’ (draft 

trading partner guidance). FDA is 

issuing this guidance to assist industry 

and State and local governments in 

understanding how to categorize the 

entities in the drug supply chain in 

accordance with the Drug Supply Chain 

Security Act (DSCSA). This guidance 

explains how to determine when certain 

statutory requirements will apply to 

entities that may be considered trading 

partners in the drug supply chain. FDA 

is also soliciting public input specific to 

the activities of ‘‘private-label 

distributors’’ of drug products and 

whether those activities fall within the 

definitions under DSCSA of the various 

trading partners. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by October 23, 

2017. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 


rmajette on DSKBCKNHB2PROD with NOTICES
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. 


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