84148 Federal Register / Vol. 88, No. 231 / Monday, December 4, 2023 / Notices 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: November 29, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26564 Filed 12–1–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–1929] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Orphan Drugs 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 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 

(PRA). 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by January 3, 

2024. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0167. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, 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. 

Orphan Drugs—21 CFR Part 316 

OMB Control Number 0910–0167— 

Extension 

This information collection helps 

support implementation of sections 525, 

526, 527, and 528 of the Federal Food, 

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

U.S.C. 360aa, 360bb, 360cc, and 360dd), 

as well as related guidance and Agency 

forms. Sections 525, 526, 527, and 528 

of the FD&C Act pertain to the 

development of drugs for rare diseases 

or conditions, including biological 

products and antibiotics, otherwise 

known or referred to as ‘‘orphan drugs.’’ 

Specifically, section 525 of the FD&C 

Act requires written recommendations 

on studies required for approval of a 

marketing application for a drug for a 

rare disease or condition. Section 526 of 

the FD&C Act provides for designation 

of drugs as orphan drugs when certain 

conditions are met; section 527 provides 

conditions under which a sponsor of an 

approved orphan drug enjoys exclusive 

FDA marketing approval for that drug 

for the orphan indication for a period of 

7 years; and, finally, section 528 is 

intended to encourage sponsors to make 

investigational orphan drugs available 

for treatment of persons in need on an 

open protocol basis before the drug has 

been approved for general marketing. 

Open protocols may permit patients 

who are not part of the formal clinical 

investigation to obtain treatment where 

adequate supplies exist and no 

alternative effective therapy is available. 

Agency regulations in part 316, 

subpart A (21 CFR part 316, subpart A) 

(§§ 316.1 through 316.4) identify the 

scope of coverage, applicable 

definitions, and statutory provisions 

applicable to orphan drugs. The 

regulations in part 316, subpart B 

(§§ 316.10 through 316.14) set forth 

content and format elements for written 

recommendation requests and discuss 

FDA providing or refusing to provide 

the requested written recommendations. 

Similarly, regulations in part 316, 

subpart C (§§ 316.20 through 316.30) 

prescribe content and format elements 

for requesting orphan drug designation; 

identify submission schedules for 

requisite information including 

amendments, updates, and reports; and 

provide for publication and revocation 

of orphan drug designation. Regulations 

in part 316, subparts D and E (§§ 316.31 

through 316.40) address orphan drug 

exclusive approval and open protocols 

for investigations, respectively. Finally, 

regulations in part 316, subpart F 

(§§ 316.50 through 316.52) provide for 

the issuance of guidance documents that 

apply to the orphan drug provisions of 

the FD&C Act and regulations in part 

316. The list is maintained on the 

internet and guidance documents are 

issued in accordance with our good 

guidance practices regulation in 21 CFR 

10.115, which provide for public 

comment at any time. 

The information collection includes 

the Agency guidance document entitled 

‘‘Meetings with the Office of Orphan 

Products Development: Guidance for 

Industry, Researchers, Patient Groups, 

and Food and Drug Administration 

Staff’’ (July 2015), available for 

download at: https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/meetings-officeorphan-products-development. It 

provides recommendations to industry, 

researchers, patient groups, and other 

stakeholders interested in requesting a 

meeting, including a teleconference, 

with the Office of Orphan Products 

Development (OOPD) on issues related 

to orphan drug designation requests, 

humanitarian use device designation 

requests, rare pediatric disease 

designation requests, funding 

opportunities through the Orphan 

Products Grants Program and the 

Pediatric Device Consortia Grants 

Program, and orphan product patientrelated topics of concern. It is also 

intended to assist OOPD staff in 

addressing such meeting requests. The 

guidance describes procedures for 

requesting, preparing, scheduling, 

conducting, and documenting such 

meetings and discusses background 

information we recommend be included 

in such requests. 

The information collection includes 

Form FDA 3671, Common EMEA/FDA 

Application for Orphan Medicinal 

Product, and Form FDA 4035, FDA 

Orphan Drug Designation Request Form, 

intended to benefit sponsors who desire 

to seek orphan designation of drugs 

intended for rare diseases or conditions 

from FDA. The form is a simplified 

method for sponsors to provide only the 

information required by § 316.20 for 

FDA decision making. Orphan drug 

designation requests and related 

submissions (amendments, annual 

reports, etc.), humanitarian use device 

designation, and rare pediatric disease 

designation requests and submissions 

may be submitted electronically by 

email to the OOPD. 

As communicated on our website at 

https://www.fda.gov/industry/medicalproducts-rare-diseases-and-conditions/ 

designating-orphan-product-drugs-andbiological-products, respondents may 

submit orphan drug designation 

requests electronically through the 

Center for Drug Evaluation and Research 

(CDER) NextGen portal, or by emailing 

the required information to 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 231 / Monday, December 4, 2023 / Notices 84149 

orphan@fda.hhs.gov; or by mailing the 

required information to the OOPD at the 

address found on our website. New 

users of the CDER NextGen Portal must 

register for an account. For designation 

requests submitted by email, the Agency 

recommends using automated read 

receipt to verify receipt of the email. 

Sponsors and others who plan to 

email information to FDA that is 

private, sensitive, proprietary, or 

commercial confidential are strongly 

encouraged to send it from an FDAsecured email address so the 

transmission is encrypted. The Agency 

will assume the addresses of emails 

received or email addresses provided as 

a point of contact are secure when 

responding to those email addresses. 

Sponsors and others can establish a 

secure email address link to FDA by 

sending a request to SecureEmail@

fda.hhs.gov. There may be a fee to a 

commercial enterprise for establishing a 

digital certificate before encrypted 

emails can be sent to FDA. 

Respondents to the information 

collection are sponsors who develop 

investigational drugs and biologicals for 

commercial use and who seek orphan 

drug designation, and upon approval or 

licensure, orphan drug exclusivity. 

In the Federal Register of June 13, 

2023 (88 FR 38513), we published a 60- 

day notice soliciting comment on the 

proposed collection of information. 

Although we received one comment, it 

was not responsive to the information 

collection topics solicited and therefore 

is not addressed in this notice. 

We estimate the burden of this 

collection of information as follows 

based on data from 2022: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR part or section; activity Number of 

respondents 

Number of 

records per 

recordkeeper 

Total 

annual 

records 

Average 

burden 

per record 

Total 

hours 

Part 316 associated records ................................................ 780 1.25 975 135 131,625 

§§ 316.20, 316.21, 316.26 (Form FDA 4035) ...................... 780 1.25 975 32 31,200 

§ 316.22; Notifications of changes in agents ....................... 300 1 300 0.5 150 

§ 316.24(a); Deficiency letters and granting orphan-drug 

designation ....................................................................... 20 1 20 2 40 

§ 316.27; Submissions to change ownership of orphandrug designation ............................................................... 90 1 90 3 270 

§ 316.30; Annual reports ...................................................... 2,039 1 2,039 3 6,117 

§ 316.36; Assurance of the availability of sufficient quantities of the orphan drug; holder’s consent for the approval of other marketing applications for the same drug 1 3 3 15 45 

Guidance Recommendations: Meeting requests to OOPD 

and related submission packages .................................... 807 1.5 1,211 4 4,842 

Total .............................................................................. ........................ ........................ 5,613 ........................ 174,289 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Our burden estimate includes those 

activities related to: (1) requesting 

orphan drug designation; (2) responding 

to deficiencies letters with submissions 

of amendments; (3) keeping files current 

with contact information for agents and 

transfer of ownership, when applicable; 

(4) submitting annual reports while 

products have designation status; and 

(5) requesting and preparing for both 

informal and formal meetings. Because 

the PRA defines a recordkeeping 

requirement to include reporting those 

records to the Federal government, we 

account for these activities cumulatively 

in table 1 above. Upon a recent 

evaluation of the information collection, 

we adjusted our burden estimate to 

reflect an overall increase of 50,616 

hours and an increase of 766 records 

annually. We attribute this adjustment 

to an increase in the number of 

submissions, amendments, and annual 

reports. 

Dated: November 29, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26544 Filed 12–1–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: DATA 2000 

Waiver Training Payment Program 

Application for Payment, OMB No. 

0906–0061 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than February 2, 2024. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or by mail to the 

HRSA Information Collection Clearance 

Officer, Room 14N39, 5600 Fishers 

Lane, Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Joella Roland, the HRSA 

Information Collection Clearance 

Officer, at (301) 443–3983. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

DATA 2000 Waiver Training Payment 

Program Application for Payment, OMB 

No. 0906–0061—Revision. 

Abstract: The Substance Use— 

Disorder Prevention that Promotes 

Opioid Recovery and Treatment for 

Patients and Communities (SUPPORT) 

Act (Pub. L. 115–271), section 6083, 

amended the Social Security Act 

(subsections 1834(o)(3) and 1833(bb)), 


ddrumheller on DSK120RN23PROD with NOTICES1