Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices 50133 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2017–23561 Filed 10–27–17; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Proposed Projects 

Title: Multistate Financial Institution 

Data Match and Federally Assisted State 

Transmitted Levy (MSFIDM/FAST 

Levy). 

OMB No.: 0970–0196. 

Description: Section 466(a)(17) of the 

Social Security Act (the Act) requires 

states to establish procedures for their 

child support agencies to enter into 

agreements with financial institutions 

doing business in their state for the 

purpose of securing information leading 

to the enforcement of child support 

orders. Under 452(m) and 

466(a)(17)(A)(i) of the Act, the Secretary 

may aid state agencies conducting data 

matches with financial institutions 

doing business in two or more states by 

establishing a centralized and 

standardized matching program through 

the Federal Parent Locator Service. 

To further assist states collect child 

support, the federal Office of Child 

Support Enforcement (OCSE) worked 

with child support agencies and 

financial institutions to develop the 

Federally Assisted State Transmitted 

(FAST) Levy system. 

FAST Levy is a central, standardized, 

and secure electronic process for child 

support agencies and financial 

institutions to exchange information 

about levying financial accounts to 

collect past-due support. OCSE picks up 

files created by child support agencies 

that contain FAST Levy requests and 

distributes them to financial institutions 

that use the FAST Levy system. Those 

financial institutions create response 

files that OCSE picks up and distributes 

to the child support agencies. 

The MSFIDM/FAST-Levy information 

collection activities are authorized by: 

42 U.S.C. 652(m), which authorizes 

OCSE, through the Federal Parent 

Locator Service, to aid state child 

support agencies and financial 

institutions doing business in two or 

more states reach agreements regarding 

the receipt from financial institutions, 

and the transfer to the state child 

support agencies, of information 

pertaining to the location of accounts 

held by obligors who owe past-due 

support; 42 U.S.C. 666(a)(2) and 

(c)(1)(G)(ii), which require state child 

support agencies in cases in which there 

is an arrearage to establish procedures to 

secure assets to satisfy any current 

support obligation and the arrearage by 

attaching and seizing assets of the 

obligor held in financial institutions; 42 

U.S.C. 666(a)(17)(A), which requires 

state child support agencies to establish 

procedures under which the state child 

support agencies shall enter into 

agreements with financial institutions 

doing business in the State to develop 

and operate, in coordination with 

financial institutions, and the Federal 

Parent Locator Service (in the case of 

financial institutions doing business in 

two or more States), a data match 

system, using automated data exchanges 

to the maximum extent feasible, in 

which a financial institution is required 

to quarterly provide information 

pertaining to a noncustodial parent 

owing past-due support who maintains 

an account at the institution and, in 

response to a notice of lien or levy, 

encumber or surrender, assets held; 42 

U.S.C. 652(a)(7), which requires OCSE 

to provide technical assistance to state 

child support enforcement agencies to 

help them establish effective systems for 

collecting child and spousal support; 

and, 45 CFR 303.7(a)(5), which requires 

state child support agencies to transmit 

requests for information and provide 

requested information electronically to 

the greatest extent possible. To facilitate 

this requirement for states, OCSE 

developed the FAST Levy system that 

supports the electronic exchange of lien 

and levy information between child 

support agencies and financial 

institutions. 

Respondents: Multistate Financial 

Institutions and State Child Support 

Agencies. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Financial Data Match Result File-Portal .......................................................... 192 4 5 minutes 1 64 

Election Form ................................................................................................... 30 1 0.5 15 

FAST-Levy Record Specifications: Current Financial Institutions Users to 

Program New Codes .................................................................................... 1 1 65 2 65 

FAST-Levy Record Specifications: Current State Child Support Agencies to 

Program New Codes .................................................................................... 3 1 65 195 

FAST-Levy Response Withhold Record Specifications: Financial Institutions 1 1 1,716 1,716 

FAST-Levy Request Withhold Record Specifications: State Child Support 

Agencies ....................................................................................................... 2 1 1,610 3,220 

1Estimate is approximately 5 minutes per response. For calculation, use 5/60. 

2Estimate is an average based on input from OCSE’s matching partners. 

Estimated Total Annual Burden 

Hours: 5,275. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Planning, Research and Evaluation, 330 

C Street SW., Washington, DC 20201, 

Attention Reports Clearance Officer. All 

requests should be identified by the 

information collection. Email address: 

infocollection@acf.hhs.gov 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Email: OIRA_

SUBMISSION@OMB.EOP.GOV, Attn: 


sradovich on DSK3GMQ082PROD with NOTICES
50134 Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices 

Desk Officer for the Administration for 

Children and Families. 

Bob Sargis, 

Reports Clearance Officer. 

[FR Doc. 2017–23467 Filed 10–27–17; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–1264] 

Manufacturers Sharing Patient-Specific 

Information From Medical Devices 

With Patients Upon Request; Guidance 

for Industry and Food and Drug 

Administration Staff; 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 the 

guidance entitled ‘‘Manufacturers 

Sharing Patient-Specific Information 

from Medical Devices with Patients 

Upon Request.’’ FDA developed this 

guidance to clarify our position 

regarding manufacturers appropriately 

and responsibly sharing ‘‘patientspecific information’’—information 

unique to an individual patient or 

unique to that patient’s treatment or 

diagnosis that has been recorded, stored, 

processed, retrieved, and/or derived 

from a legally marketed medical 

device—with that patient at that 

patient’s request. This guidance 

provides information and 

recommendations to industry, health 

care providers, and FDA staff about the 

mechanisms and considerations for 

device manufacturers sharing such 

information with individual patients 

when they request it. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 30, 2017. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time 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 

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– 

2016–D–1264 for ‘‘Manufacturers 

Sharing Patient-Specific Information 

from Medical Devices with Patients 

Upon Request.’’ 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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Manufacturers 

Sharing Patient-Specific Information 

from Medical Devices with Patients 

Upon Request’’ to the Office of the 

Center Director, Guidance and Policy 

Development, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

FOR FURTHER INFORMATION CONTACT: 

Esther Bleicher, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5424, Silver Spring, 

MD 20993–0002, 301–796–8547. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Increasingly, patients seek to play an 

active role in their own health care. 

FDA believes that sharing ‘‘patientspecific information’’ with patients 

upon their request may assist them in 

being more engaged with their health 

care providers in making sound medical 

decisions. For purposes of this 

guidance, ‘‘patient-specific information’’ 

is information unique to an individual 


sradovich on DSK3GMQ082PROD with NOTICES