13294 Federal Register / Vol. 87, No. 46 / Wednesday, March 9, 2022 / Notices 

Estimated Total Annual Burden 

Hours: 3,410. 

Authority: Section 471(e)(4)(E) of the 

Act (42 U.S.C. 671), as amended by 

Public Law 115–123. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–04939 Filed 3–8–22; 8:45 am] 

BILLING CODE 4184–29–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–1977–N–0015 (Formerly 

77N–0187); DESI 7663] 

Drugs for Human Use; Drug Efficacy 

Study Implementation; Potassium 

Aminobenzoate Oral Preparations; 

Withdrawal of Hearing Request; 

Withdrawal of New Drug Application; 

Final Resolution of Drug Efficacy 

Study Implementation 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing that all outstanding hearing 

requests regarding POTABA (potassium 

aminobenzoate) Tablets, Capsules, 

Powder, and Envules under Docket No. 

FDA–1977–N–0015 (formerly 77N– 

0187) (this Drug Efficacy Study 

Implementation (DESI) 7663) have been 

withdrawn. Therefore, as proposed in 

the notice of opportunity for hearing 

(NOOH), FDA finds that the products 

subject to the application identified in 

this docket, or any identical, related, or 

similar (IRS) products, have not been 

shown to be effective for use under the 

conditions of use prescribed, 

recommended, or suggested in the 

labeling, and hereby withdraws 

approval of the application under the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act). 

DATES: This notice is applicable April 8, 

2022. 

ADDRESSES: 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 

between 9 a.m. and 4 p.m., Monday 

through Friday. Publicly available 

submissions may be seen in the docket. 

The most relevant background 

documents regarding this matter are 

available in the docket. However, 

additional background documents are 

available upon request (see FOR FURTHER

INFORMATION CONTACT). 

FOR FURTHER INFORMATION CONTACT: 

Astrid Lopez-Goldberg, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 5185, 

Silver Spring, MD 20993–0002, 301– 

796–3485, email: 

Astrid.LopezGoldberg@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In 1962, Congress amended the FD&C 

Act to require that new drugs be proven 

effective for their labeled indications, as 

well as safe, in order to obtain FDA 

approval (Drug Amendments of 1962 

(Pub. L. 87–781)). These amendments 

also required FDA to conduct a 

retrospective evaluation of the 

effectiveness of the drug products that 

FDA had approved as safe between 1938 

and 1962. FDA contracted with the 

National Academy of Sciences/National 

Research Council (NAS/NRC) to make 

an initial evaluation of the effectiveness 

of over 3,400 products that had been 

approved only for safety between 1938 

and 1962. The NAS/NRC reports for 

these drug products were submitted to 

FDA in the late 1960s and early 1970s. 

The Agency reviewed and reevaluated 

the reports and published its findings in 

Federal Register notices. FDA’s 

administrative implementation of the 

NAS/NRC reports was called the DESI. 

DESI covered the approximately 3,400 

products specifically reviewed by the 

NAS/NRC, as well as the even larger 

number of IRS products that entered the 

market without FDA approval. If FDA’s 

final DESI determination classifies a 

drug product as lacking substantial 

evidence of effectiveness for one or 

more indications, that drug product and 

those IRS to it may no longer be 

marketed for such indications and are 

subject to enforcement action as 

unapproved new drugs. 

II. Final Resolution of Hearing Request 

Regarding Potassium Aminobenzoate 

Oral Preparations Under Docket No. 

FDA–1977–N–0015 (Formerly 77N– 

0187); DESI 7663 

In a Federal Register notice published 

on August 28, 1970 (35 FR 13755), FDA 

announced its evaluation of a report 

received from the NAS/NRC under DESI 

7663 regarding POTABA (potassium 

aminobenzoate) Tablets, Capsules, 

Powder, and Envules, New Drug 

Application (NDA) 007663, held by 

Glenwood LLC (formerly known as 

Glenwood Laboratories, Inc.), 83 

Summit St., Tenafly, NJ 07670 (herein 

after ‘‘Glenwood’’). The notice stated 

that the drug products were possibly 

effective in the treatment of 

scleroderma, dermatomyositis, 

morphea, linear scleroderma, 

pemphigus, and Peyronie’s Disease and 

lacked substantial evidence of 

effectiveness for the treatment of 

rheumatoid arthritis, sarcoidosis, and 

pulmonary fibrosis. Glenwood, and any 

other person marketing such drug 

products without approval, was given 

60 days to revise its labeling to delete 

those indications for which substantial 

evidence of effectiveness was lacking 

and 6 months to submit data to provide 

substantial evidence of effectiveness for 

the indications for which the drug was 

regarded as possibly effective. The 

notice stated that, at the end of the 6- 

month period, FDA would evaluate the 

data to determine whether substantial 

evidence of effectiveness had been 

provided, and, if it had not, FDA would 

initiate the withdrawal of approval of 

NDA 007663 under section 505(e) of the 

FD&C Act (21 U.S.C. 355(e)). 

Glenwood did not submit data to 

provide substantial evidence of 

effectiveness for the indications for 

which the drug was regarded as possibly 

effective within the period provided by 

the 1970 Federal Register notice, and 

the Agency issued a NOOH on the 

proposed withdrawal of approval of 

NDA 007663 in the Federal Register of 

February 4, 1972 (37 FR 2688). 

In response to a court order, FDA 

published a notice in the Federal 

Register on December 14, 1972 (37 FR 

26623), which stated that POTABA, 

among other drugs, could remain on the 

market pending completion of further 

scientific studies. 

In a Federal Register notice published 

on August 19, 1977 (42 FR 41922), the 

Agency revoked the exemption granted 

in the December 14, 1972, notice 

pursuant to which POTABA had 

remained on the market pending its 

continued study. In a separate NOOH 

for DESI 7663, also published in the 

Federal Register of August 19, 1977 (42 

FR 41921), FDA noted that Glenwood 

did not submit data providing 

substantial evidence of effectiveness 

and that no other person had submitted 

data or protocols or expressed an 

intention to perform clinical studies on 

potassium aminobenzoate. This notice 

reclassified the possibly effective 

indications to lacking substantial 

evidence of effectiveness and proposed 

to issue an order under section 505(e) of 

the FD&C Act withdrawing approval of 

Glenwood’s NDA and all amendments 


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Federal Register / Vol. 87, No. 46 / Wednesday, March 9, 2022 / Notices 13295 

and supplements thereto on the grounds 

that new information, evaluated 

together with the evidence available 

when the application was approved, 

showed there is a lack of substantial 

evidence that the drug is effective under 

the conditions of use prescribed, 

recommended, or suggested in the 

labeling. The Agency again invited 

Glenwood, and any other interested 

person(s) who would be adversely 

affected by the withdrawal of approval 

of NDA 007663, to submit: (1) On or 

before September 19, 1977, a written 

notice of appearance and request for 

hearing and (2) on or before October 17, 

1977, the data, information, and 

analyses relied upon to justify a hearing. 

On September 12, 1977, Glenwood 

filed a written notice of appearance and 

requested a hearing, and on October 17, 

1977, Glenwood submitted data in 

support of its hearing request. Along 

with these submissions, Glenwood 

requested that the Agency delay action 

on the hearing request until the firm had 

conducted another placebo-controlled 

study. Subsequently, Glenwood 

initiated a clinical trial at the Downstate 

Medical Center of the State University 

of New York and supplemented its 

hearing request with additional data, 

including a progress report on the 

clinical trial of POTABA conducted at 

the Downstate Medical Center. 

Following a meeting between 

Glenwood and FDA on November 18, 

1985, Glenwood sponsored another 

controlled clinical trial, and the final 

study report was submitted on February 

4, 1993. 

By letter dated October 21, 2010, FDA 

asked Glenwood whether it wanted to 

pursue its pending hearing request 

regarding POTABA. By letter dated 

November 11, 2010, Glenwood affirmed 

its hearing request. 

By letter dated June 8, 2020, FDA 

again asked Glenwood whether it 

wanted to pursue its pending hearing 

request regarding POTABA. By letter 

dated July 2, 2020, Cheplapharm 

Arzneimittel GmbH, successor-ininterest to Glenwood LLC, stated that it 

did not wish to pursue the hearing 

request for POTABA. 

III. Conclusions and Order 

There are no outstanding hearing 

requests regarding potassium 

aminobenzoate oral preparations under 

Docket No. FDA–1977–N–0015, DESI 

7663. Therefore, as proposed in the 

NOOH, FDA withdraws approval of 

NDA 007663 under section 505(e) of the 

FD&C Act. 

Shipment in interstate commerce of 

any drug product identified in this 

docket under DESI 7663, or any IRS 

product, that is not the subject of an 

approved NDA or abbreviated new drug 

application is unlawful as of the 

effective date of this notice (see DATES). 

Any person who wishes to determine 

whether this notice covers a specific 

product should write to Astrid LopezGoldberg at the Center for Drug 

Evaluation and Research (see FOR

FURTHER INFORMATION CONTACT). Firms 

should be aware that, after the 

applicable date of this notice (see 

DATES), FDA intends to take 

enforcement action without further 

notice against any firm that 

manufactures or ships in interstate 

commerce any unapproved product 

covered by this notice. 

IV. Discontinued Products 

Firms must notify the Agency of 

certain product discontinuations in 

writing under section 506C(a) of the 

FD&C Act (21 U.S.C. 356c). See http:// 

www.fda.gov/Drugs/DrugSafety/ 

DrugShortages/ucm142398.htm. Some 

firms may have previously discontinued 

manufacturing or distributing products 

covered by this notice without 

discontinuing the listing as required 

under section 510(j) of the FD&C Act (21 

U.S.C. 360(j)). Other firms may 

discontinue manufacturing or 

distributing listed products in response 

to this notice. All firms are required to 

electronically update the listing of their 

products under 510(j) of the FD&C Act 

to reflect discontinuation of unapproved 

products covered by this notice (21 CFR 

207.57(b)). Questions on electronic drug 

listing updates should be sent to 

eDRLS@fda.hhs.gov. In addition to the 

required update, firms can also notify 

the Agency of product discontinuation 

by sending a letter, signed by the firm’s 

chief executive officer and fully 

identifying the discontinued product(s), 

including the product National Drug 

Code number(s), and stating that the 

manufacturing and/or distribution of the 

product(s) have been discontinued. The 

letter should be sent electronically to 

Astrid Lopez-Goldberg (see FOR FURTHER

INFORMATION CONTACT). FDA plans to 

rely on its existing records, including its 

drug listing records, the results of any 

future inspections, or other available 

information, when it identifies violative 

products for enforcement action. 

Dated: March 3, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–04971 Filed 3–8–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0075] 

Food and Drug Administration Quality 

Metrics Reporting Program; 

Establishment of a Public Docket; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the establishment of a 

docket to solicit comments on changes 

to FDA’s previously proposed quality 

metrics reporting program (QM 

Reporting Program). This notice 

describes considerations for refining the 

QM Reporting Program based on lessons 

learned from two pilot programs with 

industry that were announced in the 

Federal Register in June 2018, a Site 

Visit Program and a Quality Metrics 

Feedback Program, as well as 

stakeholder feedback on FDA’s 2016 

revised draft guidance for industry 

entitled ‘‘Submission of Quality Metrics 

Data.’’ FDA is interested in responses to 

the questions listed in section III of this 

document, in addition to any general 

comments on the proposed direction for 

the program. This notice is not intended 

to communicate our regulatory 

expectations for reporting quality 

metrics data to FDA but is instead 

intended to seek input from industry to 

inform the future regulatory approach. 

DATES: Submit either electronic or 

written comments by June 7, 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 June 7, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of June 7, 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:// 


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