Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices 4307 

Study Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Burden hours 

Refugee Cash and Medical Assistance Federal Financial Report (ORR–2) 

Supplemental Data Collection ...................................................................... 66 1 1.67 110 

Refugee Support Services Federal Financial Report (SF–425) Supplemental 

Data Collection ............................................................................................. 53 4 4 848 

Totals ........................................................................................................ 768 Avg: 2.7 Avg: 8.9 20,555 

Burden Estimates—New Requests 

Based on use of this generic, we have 

revised burden estimates for the next 3 

years. 

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Burden hours 

Mandatory Grant Financial Reports ................................................................. 1,200 3 9 32,400 

Comments: 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 B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–01206 Filed 1–22–24; 8:45 am] 

BILLING CODE 4184–88–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1262] 

Notice of Approval of Product Under 

Voucher: Rare Pediatric Disease 

Priority Review Voucher 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of approval of a product 

redeeming a priority review voucher. 

The Federal Food, Drug, and Cosmetic 

Act (FD&C Act) authorizes FDA to 

award priority review vouchers to 

sponsors of approved rare pediatric 

disease product applications that meet 

certain criteria. FDA is required to 

publish notice of the issuance of priority 

review vouchers as well as the approval 

of products redeeming a priority review 

voucher. FDA has determined that the 

supplemental application (Supplement35) for COSENTYX (secukinumab), 

approved June 16, 2020, meets the 

criteria for redeeming a priority review 

voucher. 

FOR FURTHER INFORMATION CONTACT: 

Cathryn Lee, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–1394, email: Cathryn.Lee@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the approval of a product 

redeeming a rare pediatric disease 

priority review voucher. Under section 

529 of the FD&C Act (21 U.S.C. 360ff), 

FDA will report the issuance of rare 

pediatric disease priority review 

vouchers and the approval of products 

for which a voucher was redeemed. 

FDA has determined that the 

supplemental application (Supplement35) for COSENTYX (secukinumab) 

meets the redemption criteria. 

For further information about the Rare 

Pediatric Disease Priority Review 

Voucher Program and for a link to the 

full text of section 529 of the FD&C Act, 

go to https://www.fda.gov/ForIndustry/ 

DevelopingProductsforRareDiseases

Conditions/RarePediatricDiseasePriority

VoucherProgram/default.htm. For 

further information about COSENTYX 

(secukinumab), go to the ‘‘Drugs@FDA’’ 

website at https://www.accessdata.fda.

gov/scripts/cder/daf/. 

Dated: January 17, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01164 Filed 1–22–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–5430] 

Characterization of Metallic Coatings 

and/or Calcium Phosphate Coatings on 

Orthopedic Devices; Draft 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 draft 

guidance entitled ‘‘Characterization of 

Metallic Coatings and/or Calcium 

Phosphate Coatings on Orthopedic 

Devices.’’ This draft guidance document 

provides recommendations for 

premarket submissions for orthopedic 

devices that contain metallic coatings 

and/or calcium phosphate coatings on 

the surface. This draft guidance is not 

final nor is it for implementation at this 

time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by March 25, 2024 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 


khammond on DSKJM1Z7X2PROD with NOTICES
4308 Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices 

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– 

2023–D–5430 for ‘‘Characterization of 

Metallic Coatings and/or Calcium 

Phosphate Coatings on Orthopedic 

Devices.’’ 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)). 

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 draft guidance 

document entitled ‘‘Characterization of 

Metallic Coatings and/or Calcium 

Phosphate Coatings on Orthopedic 

Devices’’ to the Office of Policy, 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 self-addressed adhesive label 

to assist that office in processing your 

request. 

FOR FURTHER INFORMATION CONTACT: 

Limin Sun, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4430, Silver Spring, 

MD 20993–0002, 301–796–7056. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This draft guidance document 

provides recommendations for 

premarket submissions for orthopedic 

devices that contain metallic coatings 

and/or calcium phosphate coatings on 

the surface. The recommendations in 

this document are applicable to class II 

and class III devices intended for 

orthopedic applications that contain 

metallic and/or calcium phosphate 

coatings. Specifically, this draft 

guidance addresses the characterization 

of the following coatings on orthopedic 

devices: (1) a metallic coating, which 

can be manufactured using thermal 

spray (e.g., plasma spray), sintering (e.g., 

sintering of powders, beads, or fiber 

mesh pad), chemical vapor deposition/ 

infiltration, physical vapor deposition 

(e.g., ionic plasma deposition), additive 

manufacturing (e.g., electron beam 

manufacturing, selective laser sintering), 

or other methods; (2) a calcium 

phosphate coating, which can be 

manufactured by plasma spray, solution 

precipitation, electrochemical 

deposition, or other methods; and (3) a 

metallic and calcium phosphate dual 

coating, which can be manufactured 

using one or more of the above methods. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Characterization of Metallic 

Coatings and/or Calcium Phosphate 

Coatings on Orthopedic Devices.’’ 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. 

II. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/medical-devices/ 

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This 

guidance document is also available at 

https://www.regulations.gov and https:// 

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents. 

Persons unable to download an 

electronic copy of ‘‘Characterization of 

Metallic Coatings and/or Calcium 

Phosphate Coatings on Orthopedic 

Devices’’ may send an email request to 

CDRH-Guidance@fda.hhs.gov to receive 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices 4309 

an electronic copy of the document. 

Please use the document number 

GUI00020051 and complete title to 

identify the guidance you are 

requesting. 

III. Paperwork Reduction Act of 1995 

While this guidance contains no new 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information in the following table have 

been approved by OMB: 

21 CFR part or guidance Topic OMB control No. 

807, subpart E ......................................................................... Premarket notification .............................................................. 0910–0120 

814, subparts A through E ...................................................... Premarket approval ................................................................. 0910–0231 

812 ........................................................................................... Investigational Device Exemption ........................................... 0910–0078 

‘‘Requests for Feedback and Meetings for Medical Device 

Submissions: The Q-Submission Program’’.

Q-submissions and Early Payor Feedback Request Programs for Medical Devices.0910–0756 

800, 801, 809 and 830 ............................................................ Medical Device Labeling Regulations; Unique Device Identification.0910–0485 

58 ............................................................................................. Good Laboratory Practice (GLP) Regulations for Nonclinical 

Laboratory Studies.

0910–0119 

Dated: January 17, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01158 Filed 1–22–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1262] 

Notice of Approval of Product Under 

Voucher: Rare Pediatric Disease 

Priority Review Voucher 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of approval of a product 

redeeming a priority review voucher. 

The Federal Food, Drug, and Cosmetic 

Act (FD&C Act) authorizes FDA to 

award priority review vouchers to 

sponsors of approved rare pediatric 

disease product applications that meet 

certain criteria. FDA is required to 

publish notice of the issuance of priority 

review vouchers as well as the approval 

of products redeeming a priority review 

voucher. FDA has determined that the 

supplemental application (Supplement1) for ZEPOSIA (ozanimod), approved 

May 27, 2021, meets the criteria for 

redeeming a priority review voucher. 

FOR FURTHER INFORMATION CONTACT: 

Cathryn Lee, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–1394, email: Cathryn.Lee@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the approval of a product 

redeeming a rare pediatric disease 

priority review voucher. Under section 

529 of the FD&C Act (21 U.S.C. 360ff), 

FDA will report the issuance of rare 

pediatric disease priority review 

vouchers and the approval of products 

for which a voucher was redeemed. 

FDA has determined that the 

supplemental application (Supplement1) for ZEPOSIA (ozanimod) meets the 

redemption criteria. 

For further information about the Rare 

Pediatric Disease Priority Review 

Voucher Program and for a link to the 

full text of section 529 of the FD&C Act, 

go to https://www.fda.gov/ForIndustry/ 

DevelopingProductsforRare

DiseasesConditions/RarePediatric

DiseasePriorityVoucherProgram/ 

default.htm. For further information 

about ZEPOSIA (ozanimod), go to the 

‘‘Drugs@FDA’’ website at https://

www.accessdata.fda.gov/scripts/cder/ 

daf/. 

Dated: January 17, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01160 Filed 1–22–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–5746] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Record Retention 

Requirements for the Soy Protein and 

Reduced Risk of Coronary Heart 

Disease Health Claim 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the record 

retention requirements for the soy 

protein/coronary heart disease (CHD) 

health claim. 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

March 25, 2024. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https:// 

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

March 25, 2024. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received on or before 

that date. 

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 


khammond on DSKJM1Z7X2PROD with NOTICES