40158 Federal Register / Vol. 82, No. 163 / Thursday, August 24, 2017 / Notices 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Revision of an existing 

information collection request; Title of 

Information Collection: Cooperative 

Agreements to Support Establishment of 

State-Operated Health Insurance 

Exchanges; Use: All States (including 

the 50 States, consortia of States, and 

the District of Columbia herein referred 

to as States) had the opportunity under 

Section 1311(b) of the Affordable Care 

to apply for three types of grants: (1) 

Planning grants; (2) Early Innovator 

grants for early development of 

information technology; and (3) 

Establishment grants to develop, 

implement and start-up Marketplaces. 

As of January 1st, 2017, the Secretary 

has disbursed over $5.4 billion under 

this grant program and, as of that date, 

there were 19 active establishment 

grants awarded to 12 states. As the 

State-Based Marketplaces (SBM) and 

Small Business Health Options Program 

(SHOP) have matured and moved from 

the developmental phases to fulloperation, the reporting requirements 

for the states have been modified and 

streamlined to insure only information 

necessary to provide effective oversight 

of their operations by CMS is collected. 

Given the innovative nature of 

Exchanges and the statutorilyprescribed relationship between the 

Secretary and States in their 

development and operation, it is critical 

that the Secretary work closely with 

States to provide necessary guidance 

and technical assistance to ensure that 

States can meet the prescribed 

timelines, federal requirements, and 

goals of the statute and the grants 

awarded to them. Form Number: CMS– 

10371 (OMB Control Number: 0938– 

1119); Frequency: Once; Affected 

Public: State Government agencies, nonprofit entities; Number of Respondents: 

17; Total Annual Responses: 37; Total 

Annual Hours: 12,328. (For policy 

questions regarding this collection 

contact Nickom Sukachevin at (301) 

492–4400). 

2. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved information 

collection; Title of Information 

Collection: State-based Marketplace 

Annual Reporting Tool (SMART); Use: 

The annual report is the primary vehicle 

to insure comprehensive compliance 

with all reporting requirements 

contained in the Affordable Care Act 

(ACA). It is specifically called for in 

Section 1313(a)(1) of the Act which 

requires an SBM to keep an accurate 

accounting of all activities, receipts, and 

expenditures, and to submit a report 

annually to the Secretary concerning 

such accounting. CMS will use the 

information collected from States to 

assist in determining if a State is 

maintaining a compliant operational 

Exchange. Form Number: CMS–10507 

(OMB Control Number: 0938–1244); 

Frequency: Annually; Affected Public: 

State, Local, or Tribal governments; 

Number of Respondents: 17; Total 

Annual Responses: 17; Total Annual 

Hours: 1,173. (For policy questions 

regarding this collection contact Christy 

Woods at 301–492–5140). 

3. Title of Information Collection: 

Machine Readable Data for Provider 

Network and Prescription Formulary 

Content for FFM QHPs; Type of 

Information Collection Request: 

Extension without change of a currently 

approved collection; Use: Under 45 CFR 

156.122(d)(1)(2) and 156.230(c) and in 

the final rule, Patient Protection and 

Affordable Care Act; HHS Notice of 

Benefit and Payment Parameters for 

2018 (CMS–9934–F), standards for 

qualified health plan (QHP) issuers are 

established for the submission of 

provider and formulary data in a 

machine-readable format to the 

Department of Health and Human 

Services (HHS) and for posting on issuer 

Web sites. These standards provide 

greater transparency for consumers, 

including by allowing software 

developers to access formulary and 

provider data to create innovative and 

informative tools. This Information 

Collection Request (ICR) serves as a 

formal request for 3-year OMB approval. 

On September 30, 2015, the Office of 

Management and Budget (OMB) granted 

approval to the data collection 

Information Collection for Machine 

Readable Data for Provider Network and 

Prescription Formulary Content for FFM 

QHPs. 

The burden estimates for the data 

collection requirements included in this 

package reflect the time and effort for 

QHP issuers to update and publish the 

appropriate data, and submit it to CMS. 

Form Number: CMS–10558 (OMB) 

control number: 0938–1284); Frequency: 

Annually; Affected Public: Private 

Sector, State, Business, and Not-for 

Profits; Number of Respondents: 397; 

Number of Responses: 397; Total Hours: 

208. (For questions regarding this 

collection, contact Joshua Annas at 

(301) 492–4407). 

4. Title of Information Collection: 

State Permissions for Enrollment in 

Qualified Health Plans in the Federally 

Facilitated Exchange & Non-Exchange 

Entities; Type of Information Collection 

Request: Request for a new OMB control 

number; Use: The Patient Protection and 

Affordable Care Act, Public Law 111– 

148, enacted on March 23, 2010, and the 

Health Care and Education 

Reconciliation Act, Public Law 111– 

152, enacted on March 30, 2010 

(collectively, ‘‘Affordable Care Act’’), 

expand access to health insurance for 

individuals and employees of small 

businesses through the establishment of 

new Affordable Insurance Exchanges 

(Exchanges), also called Marketplaces, 

including the Small Business Health 

Options Program (SHOP). The 

Exchanges, which became operational 

on January 1, 2014, enhance 

competition in the health insurance 

market, expand access to affordable 

health insurance for millions of 

Americans, and provide consumers with 

a place to easily compare and shop for 

health insurance coverage. 

This Information Collection Request 

(ICR) serves as the formal request for a 

new data collection associated with the 

HHS Notice of Benefit and Payment 

Parameters for 2018 Final Rule (2018 

Payment Notice). This ICR includes 

information collection requirements 

related to the ability of states to permit 

agents and brokers to assist qualified 

individuals, qualified employers, or 

qualified employees enrolling in 

Qualified Health Plans in the Federally 

Facilitated Exchange (§ 155.220) and 

ICRs related to non-exchange entities 

(§ 155.260). Form Number: CMS–10650 

(OMB control number 0938–NEW); 

Frequency: Annually; Affected Public: 

Private Sector, State, Business, and Notfor Profits; Number of Respondents: 

107,207; Number of Responses: 107,207; 

Total Annual Hours: 512,141. (For 

questions regarding this collection, 

contact Joshua Annas at (301–492– 

4407). 

Dated: August 18, 2017. 

Martique Jones, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2017–17918 Filed 8–23–17; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects: Grant Reviewer 

Recruitment. 

Title: Grant Reviewer Recruitment 

Form. 

OMB No.: 0970–0455. 

Description: The Administration for 

Children and Families’ Children’s 


rmajette on DSKBCKNHB2PROD with NOTICES
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 


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