7474 Federal Register / Vol. 87, No. 27 / Wednesday, February 9, 2022 / Notices 

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. 

Generic Drug User Fee Program 

OMB Control Number 0910–0727— 

Revision 

This information collection supports 

implementation of FDA’s Generic Drug 

User Fee program. The Generic Drug 

User Fee Amendments (GDUFA) (Pub. 

L. 112–144, Title 111) were enacted to 

speed the delivery of safe and effective 

generic drugs to the public and reduce 

costs to industry. GDUFA authorizes 

FDA to assess user fees to fund critical 

and measurable enhancements to the 

performance of FDA’s generic drugs 

program, bringing greater predictability 

and timeliness to the review of generic 

drug applications. GDUFA is currently 

authorized through September 30, 2022, 

with reauthorization activities currently 

underway. For more information 

regarding GDUFA and ongoing 

implementation, we invite you to visit 

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

industry/fda-user-fee-programs/genericdrug-user-fee-amendments. 

GDUFA is based on an agreement 

negotiated by FDA and representatives 

of the generic drug industry intended to 

address continuing regulatory 

challenges. GDUFA reflects input 

received during an open process that 

includes regular public meetings, 

posting of meeting minutes, and 

consideration of comments from a 

public docket. We are revising the 

information collection to include the 

current GDUFA agreement, or ‘‘goals 

letter,’’ as reflected in the document 

‘‘GDUFA Reauthorization Performance 

Goals and Program Enhancements Fiscal 

Years 2018–2022,’’ available for 

download from our website at https:// 

www.fda.gov/media/101052/download. 

The performance goals and program 

enhancements specified in the goals 

letter apply to aspects of the generic 

drug review program that are important 

for facilitating timely access to quality, 

affordable generic medicines. FDA is 

committed to meeting the performance 

goals specified in the goals letter and to 

continuous improvement of its 

performance. 

Included among the performance 

goals is the issuance of topic-specific 

guidance documents. We maintain a 

searchable guidance database on our 

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

regulatory-information/search-fdaguidance-documents. In publishing the 

respective notices of availability for 

each guidance document, we include an 

analysis under the PRA and invite 

public comment on the associated 

information collection 

recommendations. In addition, all 

Agency guidance documents are issued 

in accordance with our Good Guidance 

Practice regulations in 21 CFR 10.115, 

which provide for public comment at 

any time. 

We have developed Form FDA 3794, 

the Generic Drug User Fee Cover Sheet, 

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

industry/fda-user-fee-programs which 

requests the minimum necessary 

information from generic drug 

applicants to account for and track user 

fees and to determine the amount of the 

fee required. Applicants complete and 

submit the cover sheets to accompany 

payments. While applicants may submit 

payment through multiple means, all 

cover sheets are prepared using FDA’s 

web-based electronic User Fee System. 

Upon submitting the completed cover 

sheet, the User Fee System generates a 

user fee identification number, which is 

provided to applicants at the bottom of 

the cover sheet. It also notes the correct 

fiscal year user fee assessment that is 

due for the submission or program. FDA 

requests that applicants submit a copy 

of this completed cover sheet along with 

the abbreviated new drug application, as 

well as other additional GDUFA fees, so 

FDA can verify that the applicant has 

paid the correct user fee and their 

account is current. 

Respondents to the information 

collection are potential or actual generic 

drug application holders or related 

active pharmaceutical ingredient and 

finished dosage form manufacturers. 

Companies with multiple user fee 

obligations may submit a cover sheet for 

each user fee obligation. 

In the Federal Register of November 

19, 2021 (86 FR 64945), we published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

Form FDA 3794 Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

Generic Drug User Fee Cover Sheet .......................... 500 7.616 3,808 0.5(30 minutes) ...... 1,904 

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

Based on a review of the information 

collection, we have retained the 

currently approved burden estimate. 

Dated: February 3, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02689 Filed 2–8–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel NIAID New Innovators 

Awards (DP2 Clinical Trial Not Allowed). 

Date: March 10–11, 2022. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 27 / Wednesday, February 9, 2022 / Notices 7475 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3G41B, 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: Brenda Lange-Gustafson, 

Ph.D., Scientific Review Officer, Scientific 

Review Program, Division of Extramural 

Activities, National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3G41B, 

Rockville, MD 20852, (240) 669–5047, 

bgustafson@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: February 3, 2022. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–02660 Filed 2–8–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases, Special 

Emphasis Panel; NIAID, Clinical Trial 

Implementation Cooperative Agreement (U01 

Clinical Trial Required) and NIAID Clinical 

Trial Planning Grants (R34 Clinical Trial Not 

Allowed). 

Date: March 4, 2022. 

Time: 12:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3G58, 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: Anuja Mathew, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institute of Allergy and Infectious 

Diseases, National Institutes of Health, 5601 

Fishers Lane, Room 3G58, Rockville, MD 

20852, 301–761–6911, anuja.mathew@

nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS). 

Dated: February 3, 2022. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–02661 Filed 2–8–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[Docket No. USCG–2022–0050] 

Information Collection Request to 

Office of Management and Budget; 

OMB Control Number: 1625–0005 

AGENCY: Coast Guard, DHS. 

ACTION: Sixty-Day notice requesting 

comments. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, the 

U.S. Coast Guard intends to submit an 

Information Collection Request (ICR) to 

the Office of Management and Budget 

(OMB), Office of Information and 

Regulatory Affairs (OIRA), requesting an 

extension of its approval for the 

following collection of information: 

1625–0005, Application and Permit to 

Handle Hazardous Materials; without 

change. Our ICR describes the 

information we seek to collect from the 

public. Before submitting this ICR to 

OIRA, the Coast Guard is inviting 

comments as described below. 

DATES: Comments must reach the Coast 

Guard on or before April 11, 2022. 

ADDRESSES: You may submit comments 

identified by Coast Guard docket 

number [USCG–2022–0050] to the Coast 

Guard using the Federal eRulemaking 

Portal at https://www.regulations.gov. 

See the ‘‘Public participation and 

request for comments’’ portion of the 

SUPPLEMENTARY INFORMATION section for 

further instructions on submitting 

comments. 

A copy of the ICR is available through 

the docket on the internet at https://

www.regulations.gov. Additionally, 

copies are available from: 

COMMANDANT (CG–6P), ATTN: 

PAPERWORK REDUCTION ACT 

MANAGER, U.S. COAST GUARD, 2703 

MARTIN LUTHER KING JR. AVE. SE, 

STOP 7710, WASHINGTON, DC 20593– 

7710. 

FOR FURTHER INFORMATION CONTACT: A.L. 

Craig, Office of Privacy Management, 

telephone 202–475–3528, or fax 202– 

372–8405, for questions on these 

documents. 

SUPPLEMENTARY INFORMATION: 

Public Participation and Request for 

Comments 

This notice relies on the authority of 

the Paperwork Reduction Act of 1995; 

44 U.S.C. 3501 et seq., chapter 35, as 

amended. An ICR is an application to 

OIRA seeking the approval, extension, 

or renewal of a Coast Guard collection 

of information (Collection). The ICR 

contains information describing the 

Collection’s purpose, the Collection’s 

likely burden on the affected public, an 

explanation of the necessity of the 

Collection, and other important 

information describing the Collection. 

There is one ICR for each Collection. 

The Coast Guard invites comments on 

whether this ICR should be granted 

based on the Collection being necessary 

for the proper performance of 

Departmental functions. In particular, 

the Coast Guard would appreciate 

comments addressing: (1) The practical 

utility of the Collection; (2) the accuracy 

of the estimated burden of the 

Collection; (3) ways to enhance the 

quality, utility, and clarity of 

information subject to the Collection; 

and (4) ways to minimize the burden of 

the Collection on respondents, 

including the use of automated 

collection techniques or other forms of 

information technology. 

In response to your comments, we 

may revise this ICR or decide not to seek 

an extension of approval for the 

Collection. We will consider all 

comments and material received during 

the comment period. 

We encourage you to respond to this 

request by submitting comments and 

related materials. Comments must 

contain the OMB Control Number of the 

ICR and the docket number of this 

request, [USCG–2022–0050], and must 

be received by April 11, 2022. 

Submitting Comments 

We encourage you to submit 

comments through the Federal 

eRulemaking Portal at https://

www.regulations.gov. If your material 

cannot be submitted using https://

www.regulations.gov, contact the person 

in the FOR FURTHER INFORMATION

CONTACT section of this document for 

alternate instructions. Documents 

mentioned in this notice, and all public 

comments, are in our online docket at 

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

viewed by following that website’s 

instructions. Additionally, if you go to 

the online docket and sign up for email 


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