Federal Register / Vol. 88, No. 199 / Tuesday, October 17, 2023 / Notices 71575 

emergent situations. The final rule also 

provided new information regarding the 

processes and procedures for 

amendments and extensions for 

approved waiver plans. Form Number: 

CMS–10383 (OMB Control Number 

0938–1389; Frequency: Occasionally; 

Affected Public: State Governments; 

Number of Respondents: 19; Total 

Annual Responses: 399; Total Annual 

Hours: 5,549. (For policy questions 

regarding this collection contact Lina 

Rashid at 301–492–4193.) 

3. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Patient 

Protection and Affordable Care Act; 

Exchange Functions: Eligibility for 

Exemptions; Use: The data collection 

and reporting requirements in ‘‘Patient 

Protection and Affordable Care Act; 

Exchange Functions: Eligibility for 

Exemptions; Miscellaneous Minimum 

Essential Coverage Provisions’’ (78 FR 

39494 (July 1, 2013)), address federal 

requirements that states must meet with 

regard to the Exchange minimum 

function of performing eligibility 

determinations and issuing certificates 

of exemption from the shared 

responsibility payment. In the final 

regulation, CMS addresses standards 

related to eligibility, including the 

verification and eligibility 

determination process, eligibility 

redeterminations, options for states to 

rely on HHS to make eligibility 

determinations for certificates of 

exemption, and reporting. CMS 

developed four appendices of 

application materials to illustrate the 

process applicants use to apply for 

exemptions from the shared 

responsibility payment. This 

information collection requests seeks 

approval for the requirements associated 

with the collection of information 

associated with these four appendices. 

Form Number: CMS–10466 (OMB 

Control Number 0938–1190; Frequency: 

Annually; Affected Public: Individuals 

and Households—State, Local, or Tribal 

Governments; Number of Respondents: 

849; Total Annual Responses: 849; Total 

Annual Hours: 1,962. (For policy 

questions regarding this collection 

contact John Kenna at 301–492–4452.) 

Dated: October 12, 2023. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–22897 Filed 10–16–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for Office of Management 

and Budget Review; Federal Case 

Registry (Office of Management and 

Budget #0970–0421) 

AGENCY: Office of Child Support 

Enforcement, Administration for 

Children and Families, United States 

Department of Health and Human 

Services. 

ACTION: Request for public comments. 

SUMMARY: The Office of Child Support 

Enforcement (OCSE), Administration for 

Children and Families (ACF), is 

requesting from the Office of 

Management and Budget (OMB) to 

extend approval of the Federal Case 

Registry (FCR) for an additional three 

years. The current approval expires 

November 30, 2023. OCSE is proposing 

minor changes to punctuation, 

formatting, grammar, clarity, and 

spacing to enable easier completion of 

the form. 

DATES: Comments due within 30 days of 

publication. OMB must make a decision 

about 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. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. You can also obtain 

copies of the proposed collection of 

information by emailing infocollection@

acf.hhs.gov. Identify all emailed 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: The FCR is a national 

database of information pertaining to 

child support cases processed by state 

child support agencies, referred to as 

‘‘IV–D’’ cases, and non-IV–D support 

orders privately established or modified 

by courts or tribunals on or after 

October 1, 1998. FCR information is 

comprised of child support orders and 

case information from each State Case 

Registry (SCR). The FCR automatically 

compares new SCR submissions to 

existing FCR information and to wage 

and employment information in the 

National Directory of New Hires. The 

Federal Parent Locator Service notifies 

state agencies if a IV–D case participant 

in the state matches a participant in a 

IV–D or non-IV–D case in another state 

and supplies any matched wage and 

employment information. Matches 

enable state agencies to locate parties 

that live in different states to establish, 

modify, or enforce child support 

obligations; to establish paternity; to 

enforce state law regarding parental 

kidnapping; and to establish or enforce 

child custody or visitation 

determinations. 

The FCR instrument, Appendix G: 

Input Record Layout, contains minor 

changes in punctuation, formatting, 

grammar, clarity, and spacing to enable 

easier completion of the form. 

Respondents: State child support 

enforcement agencies. 

ANNUAL BURDEN ESTIMATES

Instrument 

Total 

number of 

respondents 

Annual 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual 

burden hours 

Appendix G: Input Transactions Layout .......................................................... 54 406 0.033 730 

Estimated Total Annual Burden 

Hours: 730. 

Authority: 42 U.S.C. 653(h); 42 U.S.C. 

654a(e); 42 U.S.C. 654a(f)(1). 


lotter on DSK11XQN23PROD with NOTICES1
71576 Federal Register / Vol. 88, No. 199 / Tuesday, October 17, 2023 / Notices 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2023–22809 Filed 10–16–23; 8:45 am] 

BILLING CODE 4184–41–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–2016] 

Policy for Testing of Alcohol (Ethanol) 

and Isopropyl Alcohol for Methanol; 

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 final 

guidance for industry entitled ‘‘Policy 

for Testing of Alcohol (Ethanol) and 

Isopropyl Alcohol for Methanol.’’ This 

guidance is intended to alert 

pharmaceutical manufacturers and 

pharmacists in State-licensed 

pharmacies or Federal facilities who 

engage in drug compounding to the 

potential public health hazard of 

alcohol (ethyl alcohol or ethanol) or 

isopropyl alcohol contaminated with or 

substituted with methanol. During the 

Coronavirus Disease 2019 (COVID–19) 

public health emergency (PHE), FDA 

became aware of reports of fatal 

methanol poisoning of consumers who 

ingested alcohol-based hand sanitizer 

products that were manufactured with 

methanol or methanol-contaminated 

ethanol. FDA is concerned that other 

drug products containing ethanol or 

isopropyl alcohol (pharmaceutical 

alcohol), which are widely used active 

ingredients in a variety of drug 

products, could be similarly vulnerable 

to methanol contamination. This 

guidance replaces the guidance for 

industry entitled ‘‘Policy for Testing 

Alcohol (Ethanol) and Isopropyl 

Alcohol for Methanol, Including During 

the Public Health Emergency (COVID– 

19)’’ published in January 2021. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 17, 2023. 

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– 

2020–D–2016 for ‘‘Policy for Testing of 

Alcohol (Ethanol) and Isopropyl 

Alcohol for Methanol.’’ 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, 240–402–7500. 

• 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.govinfo.gov/content/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, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the 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, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002; or to 

Policy and Regulations Staff, HFV–6, 

Center for Veterinary Medicine, Food 

and Drug Administration, 7500 Standish 

Place, Rockville, MD 20855. Send one 

self-addressed adhesive label to assist 

that office in processing your requests. 

See the SUPPLEMENTARY INFORMATION

section for electronic access to the 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Francis Godwin, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 4342, 

Silver Spring, MD 20993–0002, 301– 

796–5362; or Anne Taylor, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 


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