16006 Federal Register / Vol. 87, No. 54 / Monday, March 21, 2022 / Notices 

Dated: March 15, 2022. 

Andi Lipstein Fristedt, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs, U.S. Food and Drug 

Administration. 

[FR Doc. 2022–05892 Filed 3–18–22; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0093] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; New Molecular 

Entity New Drug Applications and 

Original Biologics License 

Applications 

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 


khammond on DSKJM1Z7X2PROD with NOTICESEN21MR22.036</GPH>

Angela Dfysdale 

VP, Regulatory Aff aits 

AbbottDiagnqstics Scarborough, Inc; 

10 Southgate Road 

Scarborough, ME04014 

Re: Revocation ofEUA2l0272 

Dear Ms. Drysdale: 

Febr:uary 24, 2022 

Tb:is letter is in response to the request from Ab tmtt Diagnostics Scarborough, Inc. ("Abbott"), 

received via email on February 21, 2022; that the U.S. Food and Drug Administration (FDA) 

revoke the EDA for the HinaxNOWCOVTD-l9AgCard2HorneTestisstted on March 31, 2021 

and amended. on September23, 2021 a:ndJa:nmuy 7, 20:22. FDA understands no product-was 

distributed under the EDA Abbott indicated thatauthoi:ization of the Bina.ffeOW COVID-19 

Ag Card2 Home Testis no longer required, in consideration of Abbott's product available under 

another BUA issued to Abbott 

Th.e authorization of a devi.ce for emergency ~se under section 564 ofthe FederaLFood, Drug, 

and Cosmetic Act (the Act)(21 U. S.C. 360hbb-3)may, J;>ursuantto section 564(g)(2) of the Act, 

be revokecl when circumstances make such revocation 11,tiJ;>rOJ:>riateto protect the public health or 

safety (sectiun. 564(g)(2)(C) of :Qie Act); BecauseAbhottlias notified FDAthatthe EUAfor 

Binax.NOW COVID-19 Ag Card 2 Home Test is no longer required and requested FDA revoke 

the BUA fat theBinaxNOW COVID-19 Ag Card 2Home Test, FDA has determined that it is 

approptiate to protect the public health or safety torevoke this authorization. Accordingly, FDA 

hereby revokes EUA2l02nfor theBinaxNOW COVID-19 Ag Catd 2 I:Iome'fest pttrsuantto 

section 564(g)(2)(C) of the Act. As of the date ofthis letter~ the Binax:N OW COVID~l 9 Ag Card 

2 HomeTest is no longer authorized for emergency use by FDA 

Notice of this revocation wtll be published in the Federaf.kegisrter, pursuantto section 564(h)(l) 

of the Act. 

Sincerely, 

Isl 

Jacqueline A. O'Shaugh:nessy, Ph.D. 

Actitig Chief Seientist 

Food and Drug Administration 
Federal Register / Vol. 87, No. 54 / Monday, March 21, 2022 / Notices 16007 

response to the notice. This notice 

solicits comments on information 

collection associated with evaluating 

FDA’s program for Enhanced Review 

Transparency and Communication (the 

Program) of new molecular entity new 

drug applications and original biologics 

license applications (BLAs). 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 20, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before May 20, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of May 20, 2022. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is 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 

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– 

2013–N–0093 for ‘‘New Molecular 

Entity New Drug Applications and 

Original Biologics License 

Applications.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), 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. 

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: Under the 

PRA (44 U.S.C. 3501–3521), 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, 

including each proposed extension of an 

existing 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. 

Evaluation of the Program for 

Enhanced Review Transparency and 

Communication for New Molecular 

Entity New Drug Applications and 

Original 351(a) Biologics License 

Applications in Prescription Drug User 

Fee Acts and 351(k) Biologics License 

Applications in Biosimilar User Fee 

Acts 

OMB Control Number 0910–0746— 

Extension 

This information collection supports 

the evaluation of certain performance 

goals and procedures set forth in what 

is known as FDA’s ‘‘goals letter’’ or 

‘‘commitment letter’’ under the sixth 

authorization of the Prescription Drug 

User Fee Act (PDUFA VI) and the 


khammond on DSKJM1Z7X2PROD with NOTICES
16008 Federal Register / Vol. 87, No. 54 / Monday, March 21, 2022 / Notices 

second authorization of the Biosimilar 

User Fee Act (BsUFA II). The goals 

letters are the result of Agency, 

industry, and public input, as 

Congressionally mandated under the 

applicable statutes. The documents 

entitled ‘‘PDUFA Reauthorization 

Performance Goals and Procedures 

Fiscal Years 2018 Through 2022,’’ and 

‘‘Biosimilar Biological Product 

Reauthorization Performance Goals and 

Procedures Fiscal Years 2018 Through 

2022’’ represent current performance 

goals agreed to by FDA in support of 

these respective programs. These 

documents are available at: https://

www.fda.gov/downloads/ForIndustry/ 

UserFees/PrescriptionDrugUserFee/ 

UCM511438.pdf; and https://

www.fda.gov/downloads/ForIndustry/ 

UserFees/BiosimilarUserFeeActBsUFA/ 

UCM521121.pdf. Work to reauthorize 

these authorities from Fiscal Years 2023 

to 2027 is ongoing. 

To implement certain performance 

goals, we established the Program to 

promote greater transparency and 

increased communication between the 

FDA review team and the applicant on 

the most innovative products that we 

review. The Program goals are intended 

to increase the efficiency and 

effectiveness of the first review cycle 

and decrease the number of review 

cycles necessary for approval so that 

patients have timely access to safe, 

effective, and high-quality new drugs 

and biologics. A key aspect of the 

extension of the Program to BsUFA II is 

to conduct an interim and final 

assessment that will evaluate how well 

the parameters of the Program have 

achieved the intended goals. Based on 

sponsors’ responses and other data, on 

December 2, 2020, we published an 

interim report that is available on FDA’s 

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

144130/download. We learned that 

under BsUFA II review, teams have 

been effective in enhancing review 

transparency and communication, with 

milestone meetings also enhancing the 

predictability of the review process. We 

have also adapted certain good practices 

identified through the Program, 

including providing pre-submission 

advice and templates; allocating time for 

applicant-identified discussion topics in 

late-cycle meetings where feasible; and 

recommending request response times 

of greater than 2 days for applicants 

with a global presence. We expect to 

continue these assessments. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Pretest .................................................................................. 5 1 5 1.5 7.5 

Interviews ............................................................................. 75 1 75 1.5 112.5 

Total .............................................................................. ........................ ........................ 80 ........................ 120 

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

We plan interviews with up to three 

applicant representatives per each 

351(k) BLA first-cycle action issued for 

applications reviewed under the 

Program. In addition, a pretest of the 

interview protocol with five 

respondents will also be conducted. 

Based on our prior experience with the 

Program and communications with the 

regulated industry, we assume that five 

applicant representatives will expend 

approximately 1.5 hours to complete the 

pretest, for a total of 7.5 burden hours. 

We further assume that up to 75 

applicant representatives (up to 3 

representatives for each of up to 25 

applications) will participate in the 

post-action interviews each year and 

that each interview will last 

approximately 1.5 hours, for a total of 

120 burden hours. Cumulatively, we 

estimate an overall decrease to the 

information collection, which 

corresponds to a decrease in 

submissions received by the Agency 

over the last 3 years. 

Dated: March 14, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–05814 Filed 3–18–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Center for Scientific 

Review Special Emphasis Panel, Topics 

in Alzheimer’s Disease, Mild Cognitive 

Impairment and Cognitive Aging, March 

25, 2022, 10:00 a.m. to March 25, 2022, 

8:00 p.m., National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 which was 

published in the Federal Register on 

March 03, 2022, FR Doc. 2022–04426, 

87 FR 12182. 

This meeting is being amended to 

change the Contact Person from 

Maribeth Champoux to Heidi Friedman, 

Ph.D., Center for Scientific Review, 

National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD, 301– 

379–5623. The meeting is closed to the 

public. 

March 15, 2022. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–05835 Filed 3–18–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Center for Scientific 

Review Special Emphasis Panel, March 

29, 2022, 1:00 p.m. to 6:00 p.m., 

National Institutes of Health, Rockledge 

II, 6701 Rockledge Drive, Bethesda, MD 

20892, which was published in the 

Federal Register on March 04, 2022, V 

87 #43 Page 12467, FR Doc No. 2022– 

04619. 

Meeting is being amended to change 

the Contact Person from Ai-Ping Zou to 

David Jollie, Ph.D., Scientific Review 

Officer, Center for Scientific Review, 

National Institutes of Health. The 

meeting is closed to the public. 

Dated: March 16, 2022. 

David W. Freeman, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–05896 Filed 3–18–22; 8:45 am] 

BILLING CODE 4140–01–P 


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