88924 Federal Register / Vol. 88, No. 246 / Tuesday, December 26, 2023 / Notices 

Supply Chain Security Act (FASCSA) 

Orders. Comments received generally 

will be posted without change to 

https://www.regulations.gov, including 

any personal and/or business 

confidential information provided. To 

confirm receipt of your comment(s), 

please check www.regulations.gov, 

approximately two-to-three days after 

submission to verify posting. 

FOR FURTHER INFORMATION CONTACT: 

Marissa Ryba, Procurement Analyst, at 

telephone 314–586–1280, or 

Marissa.Ryba@gsa.gov. 

SUPPLEMENTARY INFORMATION: 

A. OMB Control Number, Title, and any 

Associated Form(s) 

9000–0205, Implementation of 

Federal Acquisition Supply Chain 

Security Act (FASCSA) Orders 

B. Need and Uses 

This clearance covers the information 

that offerors and contractors must 

submit to comply with the following 

FAR requirements: 

a. FAR 52.204–29, Federal 

Acquisition Supply Chain Security Act 

Orders-Representation and Disclosures. 

This provision prohibits contractors 

from providing or using as part of the 

performance of the contract any covered 

article, or any products or services 

produced or provided by a source, if the 

covered article or the source is subject 

to an applicable FASCSA order 

identified in the clause at FAR 52.204– 

30(b)(1). 

By submitting an offer, offerors are 

representing compliance with the 

prohibition. If an offeror cannot 

represent compliance with the 

prohibition, then the offeror must 

disclose the following information in 

accordance with 52.204–29(e): 

(1) Name of the product or service 

provided to the Government; 

(2) Name of the covered article or 

source subject to an FASCA order; 

(3) If applicable, name of the vendor, 

including the Commercial and 

Government Entity code and unique 

entity identifier (if known), that 

supplied the covered article or the 

product or service to the Offeror; 

(4) Brand; 

(5) Model number (original equipment 

manufacturer number, manufacturer 

part number, or wholesaler number); 

(6) Item description; 

(7) Reason why the applicable 

covered article or the product or service 

is being provided; 

b. FAR 52.204–30, Federal 

Acquisition Supply Chain Security Act 

Orders-Prohibition. This clause requires 

contractors to provide a report to the 

Government within 3 business days if 

the contractor identifies that the 

contractor or any-tier subcontractor, 

delivered or used a covered article or 

product or service subject to a FASCSA 

order. The report requires the following 

information: 

(1) Contract number; 

(2) Order number(s), if applicable; 

(3) Name of the product or service 

provided to the Government; 

(4) Name of the covered article or 

source subject to a FASCSA order; 

(5) If applicable, name of the vendor, 

including the Commercial and 

Government Entity code and unique 

entity identifier (if known), that 

supplied the covered article or the 

product or service to the Contractor; 

(6) Brand; 

(7) Model number (original equipment 

manufacturer number, manufacturer 

part number, or wholesaler number); 

(8) Item description; and 

(9) Any readily available information 

about mitigation actions undertaken or 

recommended. 

The contractor must also submit 

additional information within 10 days 

of submitting the first report identifying 

any further available information about 

mitigation actions undertaken or 

recommended. Additionally, the 

contractor shall describe the efforts it 

undertook to prevent submission and 

any additional efforts to prevent future 

submission of the covered article or the 

product or service produced or provided 

by a source subject to an applicable 

FASCSA order. 

FAR provision 52.204–29. 

Information collected under will be by 

the government to determine whether to 

seek a waiver from a FASCSA order 

issued under the authority of the 

Federal Acquisition Supply Chain 

Security Act of 2018. 

FAR clause 52.204–30 will 

Information collected will be used by 

the contracting officer working with the 

requirement activity to determine 

whether it is necessary to take further 

action and modify the contract. 

C. Annual Burden 

Respondents/Recordkeepers: 6,113. 

Total Annual Responses: 1. 

Total Burden Hours: 12,226. 

Obtaining Copies: Requesters may 

obtain a copy of the information 

collection documents from the GSA 

Regulatory Secretariat Division by 

calling 202–501–4755 or emailing 

GSARegSec@gsa.gov. Please cite OMB 

Control No. 9000–0205, Implementation 

of Federal Acquisition Supply Chain 

Security Act (FASCSA) Orders. 

Janet Fry, 

Director, Federal Acquisition Policy Division, 

Office of Governmentwide Acquisition Policy, 

Office of Acquisition Policy, Office of 

Governmentwide Policy. 

[FR Doc. 2023–28419 Filed 12–22–23; 8:45 am] 

BILLING CODE 6820–EP–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–2818] 

Rare Diseases: Considerations for the 

Development of Drugs and Biological 

Products; 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 ‘‘Rare 

Diseases: Considerations for the 

Development of Drugs and Biological 

Products.’’ This guidance is intended to 

assist sponsors of drugs and biological 

products for treatment of rare diseases 

in conducting efficient and successful 

drug development programs through a 

discussion of selected issues commonly 

encountered in rare disease drug 

development. This guidance finalizes 

the draft guidance entitled ‘‘Rare 

Diseases: Common Issues in Drug 

Development’’ issued on February 1, 

2019. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 26, 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 


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Federal Register / Vol. 88, No. 246 / Tuesday, December 26, 2023 / Notices 88925 

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– 

2015–D–2818 for ‘‘Rare Diseases: 

Considerations for the Development of 

Drugs and Biological Products.’’ 

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 this 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 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. 

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: 

Andrea Bell-Vlasov, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 6484, 

Silver Spring, MD 20993–0002, 240– 

402–4977; 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, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a final guidance for industry entitled 

‘‘Rare Diseases: Considerations for the 

Development of Drugs and Biological 

Products.’’ This guidance is intended to 

assist sponsors of drugs and biological 

products for treatment of rare diseases 

in conducting efficient and successful 

product development programs through 

a discussion of selected issues 

commonly encountered in rare disease 

drug development. This final guidance 

addresses important aspects of drug and 

biological product development to 

support the proposed clinical 

investigation(s), including nonclinical 

pharmacology/toxicology; trial design 

and endpoint considerations to ensure 

quality and interpretability of data; 

standard of evidence to establish safety 

and effectiveness; and drug 

manufacturing considerations during 

drug development. 

This guidance finalizes the draft 

guidance entitled ‘‘Rare Diseases: 

Common Issues in Drug Development’’ 

issued February 1, 2019 (84 FR 1156). 

Changes made from the draft to the final 

guidance took into consideration 

comments received. Major changes 

include the removal of the natural 

history section (because this is 

addressed in a separate guidance), 

additional considerations regarding 

nonclinical studies, information on the 

use of external controls and early 

randomization, a section discussing 

safety considerations, information on 

changes to drug substance or 

manufacturing process, and sections 

discussing participation of patients/ 

patient groups in drug development 

programs and pediatric considerations 

in rare disease drug development. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Rare Diseases: 

Considerations for the Development of 

Drugs and Biological Products.’’ 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. Paperwork Reduction Act of 1995 

While this guidance contains no 

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 following collections of 

information in the final guidance have 

been approved under OMB control 

number 0910–0001: 

• Submitting under 21 CFR 

314.50(c)(1)(iv) and (d)(3) 

(§ 314.50(c)(1)(iv) and (d)(3)) a summary 

of the nonclinical pharmacology and 

toxicology section and the human 

pharmacokinetics and bioavailability 

section of new drug application (NDAs); 


khammond on DSKJM1Z7X2PROD with NOTICES
88926 Federal Register / Vol. 88, No. 246 / Tuesday, December 26, 2023 / Notices 

• Submitting under § 314.50(d)(1)(i) 

chemistry, manufacturing, and controls 

information, including the drug 

substance, for the content and format of 

an NDA for rare diseases; and 

• Submitting under § 314.50(d)(5) and 

(d)(5)(iv) clinical data of a drug, 

including a description of any other 

data information relevant to an 

evaluation of the safety and 

effectiveness of a drug. 

• Submissions under 21 CFR part 

314, subpart H, to grant accelerated 

approval of new drugs for serious or 

life-threatening illnesses. 

• Submissions under §§ 312.47 and 

312.82 for requesting meetings with 

FDA about drug development programs. 

The following collections of 

information in the final guidance have 

been approved under OMB control 

number 0910–0014: 

• Submitting under 21 CFR 

312.23(a)(6)(i) (§ 312.23(a)(6)(i)) a 

protocol for the duration of a trial and 

the criteria to enter a trial and under 

§ 312.23(a)(6)(i), (a)(6)(iii)(d) and (g) a 

description of an estimate of patients 

that will be involved in a trial, 

including a description of the safety 

exclusions and a description of clinical 

procedures, laboratory, or other 

methods. 

• Submitting under § 312.23(a)(3)(i) a 

brief introductory statement and general 

investigational plan, including the route 

of administration of a drug; 

• Submitting under § 312.23(a)(7) and 

(a)(7)(iv)(a) chemistry, manufacturing, 

and controls information for the content 

and format of an investigational new 

drug application (IND) and the safety 

and effectiveness of such information; 

• Submitting under § 312.23(a)(8) and 

(a)(8)(i) pharmacology, toxicology, and 

drug disposition information for rare 

diseases; 

• Submitting under 312.23(a)(10)(iii) 

plans for assessing pediatric safety and 

effectiveness; 

• Submitting under § 312.32(c)(1) IND 

safety reports; 

• Submissions under §§ 312.305(b) 

and 312.310(b) for expanded access uses 

and treatment of an individual patient. 

The collections of information in 21 

CFR part 316 for submitting the content 

and format of NDAs for orphan drugs 

have been approved under OMB control 

number 0910–0167. The collections of 

information pertaining to postmarketing 

adverse drug experience reporting have 

been approved under OMB control 

number 0910–0230. The collections of 

information pertaining to expedited 

review programs for serious conditions, 

accelerated approval, breakthrough 

therapy-designation, and fast-track 

designation, have been approved under 

OMB control number 0910–0765. The 

collections of information in 21 CFR 

part 58 pertaining to good laboratory 

practices have been approved under 

OMB control number 0910–0119. The 

collection of information pertaining to 

current good manufacturing practices 

have been approved under OMB control 

number 0910–0139. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: December 18, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–28310 Filed 12–22–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–30D] 

Agency Information Collection 

Request. 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before January 25, 2024. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov or by calling 

(202) 264–0041 and PRA@HHS.GOV 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 0990–0313 and 

project title for reference, to Sherrette A. 

Funn, email: Sherrette.Funn@hhs.gov, 

PRA@HHS.GOV or call (202) 264–0041 

the Reports Clearance Officer. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: National Blood 

Collection & Utilization Survey 

(NBCUS) 

Type of Collection: Revision 

OMB No. 0990–30D–0313 Office of 

the Assistant Secretary for Health/HHS 

Abstract 

The Office of the Assistant Secretary 

for Health (OASH) is requesting 

approval for a three-year revised 

information collection request (ICR) 

titled ‘‘National Blood Collection & 

Utilization Survey (NBCUS).’’ The 

NBCUS is a biennial survey that 

includes a core of standard questions on 

blood collection, processing, and 

utilization practices. Questions on 

transfusion-transmitted infections, 

transfusion associated circulatory 

overload, acute hemolysis, delayed 

hemolysis, and severe allergic reactions 

are also included in the survey. The 

rapidly changing environment in blood 

supply and demand makes it important 

to have regular, periodic data describing 

the state of U.S. blood collections and 

transfusions for understanding the 

dynamics of blood safety and 

availability. In 2023, two sections were 

removed from the survey related to the 

impact of the COVID–19 pandemic on 

the blood supply during the course of 

2020. 

Survey respondents will consist of 

blood collection centers and hospitals 

that perform blood transfusions, except 

those reporting fewer than 100 inpatient 

surgeries per year. For the purposes of 

this ICR, federal burden is only being 

placed on facilities located within the 

fifty states and the District of Columbia. 

The total estimated burden is 5,106 

hours. 


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