1924 Federal Register / Vol. 89, No. 8 / Thursday, January 11, 2024 / Notices 

During the assessment of an ANDA, 

FDA considers important issues that are 

central to product evaluation. 

Sometimes, an applicant may disagree 

with FDA, and because these 

disagreements often involve intricate 

matters, it is critical to have procedures 

in place to ensure open and prompt 

consideration of an applicant’s 

concern(s). The procedures and policies 

described in this guidance are intended 

to formalize FDA’s current and 

historical practices and to continue to 

promote rapid and fair resolution of 

eligible requests between an applicant 

and FDA. This draft guidance revises 

the draft guidance of the same title 

issued on October 12, 2017 (82 FR 

47531). This revision is being issued to 

reflect the most recent reauthorization 

of GDUFA in the Continuing 

Appropriations and Ukraine 

Supplemental Appropriations Act, 2023 

(Division F, Title III, Pub. L. 117–180, 

136 Stat. 2155), and to clarify what 

matters are appropriate for requests for 

reconsideration. 

This draft guidance is being issued 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The draft guidance, when finalized, will 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 ‘‘Requests for Reconsideration at the 

Division Level Under GDUFA.’’ 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 

Under the Paperwork Reduction Act 

of 1995 (PRA) (44 U.S.C. 3501–3520), 

Federal agencies must obtain approval 

from the Office of Management and 

Budget (OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Applications for FDA Approval To 

Market a New Drug 

OMB Control Number 0910–0001— 

Revision 

The information collection request 

supports the Agency’s draft guidance 

entitled, ‘‘Requests for Reconsideration 

at the Division Level Under GDUFA.’’ 

As discussed in section I of this notice, 

this draft guidance provides information 

to respondents regarding procedures for 

submitting requests for reconsideration, 

including details on the content and 

format of the submission. Respondents 

to the collection of information are 

applicants of ANDAs. Based on 

available data with regard to similar 

information collections, FDA’s Center 

for Drug Evaluation and Research will 

receive approximately 310 requests for 

reconsideration annually from 155 

respondents. Because we estimate it will 

take 5 hours to prepare a request for 

reconsideration, we estimate it will take 

an average of 1,550 total hours annually 

for respondents to prepare and submit 

requests for reconsideration. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Section of guidance/reporting activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(in hours) 

Total hours 

Section IV: Procedures for Submitting and Responding to 

a Request for Reconsideration ........................................ 155 2 310 5 1,550 

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

This draft guidance refers to 

previously approved FDA collections of 

information found in FDA regulations. 

The collections of information in 21 

CFR part 314 have been approved under 

OMB control number 0910–0001. The 

collections of information pertaining to 

the GDUFA III commitment letter, 

meetings related to generic drug 

development, and the Generic Drug 

User Fee Program have been approved 

under OMB control number 0910–0727. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

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

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

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

www.regulations.gov. 

Dated: January 8, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–00403 Filed 1–10–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–0026] 

Issuance of Priority Review Voucher; 

Rare Pediatric Disease Product 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of a priority review voucher to 

the sponsor of a rare pediatric disease 

product application. The Federal Food, 

Drug, and Cosmetic Act (FD&C Act) 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 8 / Thursday, January 11, 2024 / Notices 1925 

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 award 

of the priority review voucher. FDA has 

determined that FILSUVEZ (birch 

triterpenes), manufactured by Amryt 

Pharmaceuticals, meets the criteria for 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. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the issuance of a priority 

review voucher to the sponsor of an 

approved rare pediatric disease product 

application. Under section 529 of the 

FD&C Act (21 U.S.C. 360ff), FDA will 

award priority review vouchers to 

sponsors of approved rare pediatric 

disease product applications that meet 

certain criteria. FDA has determined 

that FILSUVEZ (birch triterpenes), 

manufactured by Amryt 

Pharmaceuticals, meets the criteria for a 

priority review voucher. FILSUVEZ 

(birch triterpenes) gel is indicated for 

the treatment of wounds associated with 

dystrophic and junctional epidermolysis 

bullosa in adult and pediatric patients 6 

months of age and older. 

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 http://www.fda.gov/ForIndustry/ 

DevelopingProductsforRare

DiseasesConditions/RarePediatric

DiseasePriorityVoucherProgram/

default.htm. For further information 

about FILSUVEZ (birch triterpenes), go 

to the ‘‘Drugs@FDA’’ website at http:// 

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

daf/. 

Dated: January 8, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–00400 Filed 1–10–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–0026] 

Issuance of Priority Review Voucher; 

Rare Pediatric Disease Product 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of a priority review voucher to 

the sponsor of a rare pediatric disease 

product application. 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 award 

of the priority review voucher. FDA has 

determined that ADZYNMA 

(ADAMTS13, recombinant-krhn), 

manufactured by Takeda 

Pharmaceuticals U.S.A., Inc., meets the 

criteria for a priority review voucher. 

FOR FURTHER INFORMATION CONTACT: 

Myrna Hanna, 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: FDA is 

announcing the issuance of a priority 

review voucher to the sponsor of an 

approved rare pediatric disease product 

application. Under section 529 of the 

FD&C Act (21 U.S.C. 360ff), FDA will 

award priority review vouchers to 

sponsors of approved rare pediatric 

disease product applications that meet 

certain criteria. FDA has determined 

that ADZYNMA (ADAMTS13, 

recombinant-krhn), manufactured by 

Takeda Pharmaceuticals U.S.A., Inc., 

meets the criteria for a priority review 

voucher. 

ADZYNMA (ADAMTS13, 

recombinant-krhn) is indicated for 

prophylactic or on-demand enzyme 

replacement therapy in adult and 

pediatric patients with congenital 

thrombotic thrombocytopenic purpura. 

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/industry/ 

developing-products-rare-diseasesconditions/rare-pediatric-disease-rpddesignation-and-voucher-programs. For 

further information about ADZYNMA 

(ADAMTS13, recombinant-krhn), go to 

the Center for Biologics Evaluation and 

Research’s Approved Blood Products 

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

vaccines-blood-biologics/adzynma. 

Dated: January 8, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–00401 Filed 1–10–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–2512] 

Q5A(R2) Viral Safety Evaluation of 

Biotechnology Products Derived From 

Cell Lines of Human or Animal Origin; 

International Council for 

Harmonisation; 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 ‘‘Q5A(R2) 

Viral Safety Evaluation of Biotechnology 

Products Derived from Cell Lines of 

Human or Animal Origin.’’ The 

guidance was prepared under the 

auspices of the International Council for 

Harmonisation of Technical 

Requirements for Pharmaceuticals for 

Human Use (ICH). The guidance is 

intended to describe risk-based 

principles and mitigation strategies to 

assure the viral safety of biotechnology 

products, including the data necessary 

to submit in a marketing application. 

The guidance also finalizes the updates 

based on advances in scientific 

knowledge and regulatory expectations 

to the first version of the ICH guidance 

for industry ‘‘Q5A Viral Safety 

Evaluation of Biotechnology Products 

Derived from Cell Lines of Human or 

Animal Origin,’’ issued in September 

1998. Lastly, the guidance replaces the 

draft guidance ‘‘Q5A(R2) Viral Safety 

Evaluation of Biotechnology Products 

Derived from Cell Lines of Human or 

Animal Origin’’ issued on November 14, 

2022. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on January 11, 2024. 

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 


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