2162 Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Notices 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by February 15, 2018. 

ADDRESSES: When commenting on the 

proposed information collections, 

please reference the document identifier 

or OMB control number. To be assured 

consideration, comments and 

recommendations must be received by 

the OMB desk officer via one of the 

following transmissions: OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–5806 OR, Email: 

OIRA_submission@omb.eop.gov. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ website address at 

website address at https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing.html. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. The term ‘‘collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3(c) and 

includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires federal agencies 

to publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection; 

Title of Information Collection: 

Medicare Authorization to Disclose 

Personal Health Information; Use: 

Unless permitted or required by law, the 

Health Insurance Portability and 

Accountability Act (HIPAA) Privacy 

Rule (§ 164.508) prohibits Medicare (a 

HIPAA covered entity) from disclosing 

an individual’s protected health 

information without a valid 

authorization. In order to be valid, an 

authorization must include specified 

core elements and statements. Medicare 

will make available to Medicare 

beneficiaries a standard, valid 

authorization to enable beneficiaries to 

request the disclosure of their protected 

health information. This standard 

authorization will simplify the process 

of requesting information disclosure for 

beneficiaries and minimize the response 

time for Medicare. Form CMS–10106, 

the Medicare Authorization to Disclose 

Personal Health Information, will be 

used by Medicare beneficiaries to 

authorize Medicare to disclose their 

protected health information to a third 

party. Form Number: CMS–10106 (OMB 

control number: 0938–0930); Frequency: 

Occasionally; Affected Public: 

Individuals or Households; Number of 

Respondents: 2,200,000; Total Annual 

Responses: 2,200,000; Total Annual 

Hours: 550,000. (For policy questions 

regarding this collection contact Sam 

Jenkins at 410–786–3261.) 

Dated: January 9, 2018. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2018–00486 Filed 1–12–18; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

[OMB NO.: 0970–0440] 

Proposed Information Collection 

Activity; Comment Request; Job 

Search Assistance (JSA) Strategies 

Evaluation—Extension 

Description: The Administration for 

Children and Families (ACF), is 

proposing the extension without 

changes to an existing data collection 

activity as part of the Job Search 

Assistance (JSA) Strategies Evaluation. 

The JSA evaluation will aim to 

determine which JSA strategies are most 

effective in moving TANF applicants 

and recipients into work and will 

produce impact and implementation 

findings. To date, the study has 

randomly assigned individuals to 

contrasting JSA approaches. The study 

will next compare participant 

employment and earnings to determine 

the relative effectiveness of these 

strategies. The project will also report 

on the implementation of these 

strategies, including measures of 

services participants receive under each 

approach, as well as provide operational 

lessons gathered directly from 

practitioners. 

Data collection efforts previously 

approved for JSA, include: Data 

collection activities to document 

program implementation, a staff survey, 

a baseline information form for program 

participants, and a follow-up survey for 

JSA participants approximately 6 

months after program enrollment. 

Approval for these activities expires on 

February 28, 2018. 

This Federal Register Notice provides 

the opportunity to comment on the 

extension of the 6-month follow-up 

survey to allow follow-up data to be 

collected for all study participants. 

Although the enrollment period was 

originally estimated to span 12 months, 

it took 18 months to complete 

enrollment, leaving insufficient time to 

complete the 6-month follow-up survey. 

A four-month extension is requested in 

order to allow individuals randomly 

assigned between June and August 2017 

to complete the follow-up survey in the 

same timeframe as earlier enrollees. The 

purpose of the survey is to follow-up 

with study participants and document 

their job search assistance services and 

experiences including their receipt of 

job search assistance services, their 

knowledge and skills for conducting a 

job search, the nature of their job search 

process, including tools and services 

used to locate employment, and their 

search outputs and outcomes, such as 

the number of applications submitted, 

interviews attended, offers received and 

jobs obtained. In addition, the survey 

will provide an opportunity for 

respondents to provide contact data for 

possible longer-term follow-up. There 

are no changes to the currently 

approved instruments. 

Respondents: JSA study participants. 

Annual Burden Estimates 

This extension is specific to the 6- 

month survey and covers the remaining 

766 participants that may be completing 

the six-month follow up survey during 

the four-month extension period. All 

other information collection under 

0970–0440 will be complete by the 

original OMB expiration date of 

February 28, 2018. 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Notices 2163 

Instrument 

Total/annual 

number 

of respondents 

Number of responses 

per respondent 

Average 

burden hours 

per response 

Annual 

burden hours 

Extension of Previously Approved Information Collection 

6-Month Follow-Up Survey .............................................................................. 766 1 .333 255 

Estimated Total Annual Burden 

Hours: 255. 

In compliance with the requirements 

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

Paperwork Reduction Act of 1995, 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: OPRE 

Reports Clearance Officer. Email 

address: OPREinfocollection@

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. 

Mary Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2018–00612 Filed 1–12–18; 8:45 am] 

BILLING CODE 4184–09–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5569] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Devices; 

Device Tracking 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by February 

15, 2018. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0442. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Medical Devices; Device Tracking—21 

CFR Part 821 

OMB Control Number 0910–0442— 

Extension 

Section 211 of the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA) (Pub. L. 105–115) 

became effective on February 19, 1998. 

FDAMA amended the previous medical 

device tracking provisions under section 

519(e)(1) and (2) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 360i(e)(1) and (2)) that were 

added by the Safe Medical Devices Act 

of 1990 (SMDA) (Pub. L. 101–629). 

Unlike the tracking provisions under 

SMDA, which required tracking of any 

medical device meeting certain criteria, 

FDAMA allows FDA discretion in 

applying tracking provisions to medical 

devices meeting certain criteria and 

provides that tracking requirements for 

medical devices can be imposed only 

after FDA issues an order. In the Federal 

Register of February 8, 2002 (67 FR 

5943), FDA issued a final rule that 

conformed existing tracking regulations 

to changes in tracking provisions 

effected by FDAMA under part 821 (21 

CFR part 821). 

Section 519(e)(1) of the FD&C Act, as 

amended by FDAMA, provides that 

FDA may require by order that a 

manufacturer adopt a method for 

tracking a class II or III medical device, 

if the device meets one of the three 

following criteria: (1) The failure of the 

device would be reasonably likely to 

have serious adverse health 

consequences, (2) the device is intended 

to be implanted in the human body for 

more than 1 year (referred to as a 

‘‘tracked implant’’), or (3) the device is 

life-sustaining or life-supporting 

(referred to as a ‘‘tracked l/s-l/s device’’) 

and is used outside a device user 

facility. 

Tracked device information is 

collected to facilitate identifying the 

current location of medical devices and 

patients possessing those devices, to the 

extent that patients permit the 

collection of identifying information. 

Manufacturers and FDA (where 

necessary) use the data to: (1) Expedite 

the recall of distributed medical devices 

that are dangerous or defective and (2) 

facilitate the timely notification of 

patients or licensed practitioners of the 

risks associated with the medical 

device. 

In addition, the regulations include 

provisions for: (1) Exemptions and 

variances; (2) system and content 

requirements for tracking; (3) 


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