Federal Register / Vol. 87, No. 46 / Wednesday, March 9, 2022 / Notices 13293 

FOR FURTHER INFORMATION CONTACT: 

William Cody, Secretary; Phone: (202) 

523–5725; Email: secretary@fmc.gov. 

SUPPLEMENTARY INFORMATION: On 

December 28, 2021, the Commission 

issued three policy statements to 

provide guidance to shippers and others 

on bringing private party complaints at 

the Commission and to address barriers 

identified by the trade community as 

disincentives to filing actions at the 

agency. The Commission voted in 

September 2021 to adopt the 

recommendation of the Fact Finding 

Officer of Fact Finding No. 29: 

International Ocean Transportation 

Supply Chain Engagement to issue 

policy statements on the anti-retaliation 

provision of the Shipping Act (46 U.S.C. 

41104(a)(3)), the standard for recovering 

attorney fees in private party 

complaints, and the ability of shippers’ 

associations and trade associations to 

file a complaint with the Commission 

alleging a violation of the Shipping Act. 

Policy Statement on Representative 

Complaints: In the first policy 

statement, the Commission restates that 

shippers’ associations and trade 

associations may file complaints 

alleging violations of 46 U.S.C. Chapter 

411. 

Policy Statement on Attorney Fees: 

The second policy statement explains 

the Commission’s approach on attorney 

fees and reiterates that a party who 

brings an unsuccessful complaint is not 

automatically required to pay the other 

party’s attorney fees. 

Policy Statement on Retaliation: 

Finally, in the third statement on 

retaliation, the Commission emphasizes 

that it broadly defines both who can 

bring a retaliation complaint, as well as 

the types of shipper activity that are 

protected under the existing retaliation 

prohibitions. This policy statement also 

addresses the proof necessary for certain 

retaliation complaints. 

The policy statements can be found at 

the following link: https://www.fmc.gov/ 

resources-services/filing-a-shipping-actcomplaint/. 

By the Commission. 

William Cody, 

Secretary. 

[FR Doc. 2022–04658 Filed 3–8–22; 8:45 am] 

BILLING CODE 6730–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Prevention Services Data Collection 

(OMB #0970–0529) 

AGENCY: Children’s Bureau, 

Administration for Children and 

Families, HHS. 

ACTION: Request for public comment. 

SUMMARY: The Administration for 

Children and Families (ACF), Children’s 

Bureau is requesting a 3-year extension 

of the Prevention Services Data 

Collection (OMB #0970–0529, 

expiration 7/31/2022). There are no 

changes requested to the form. 

DATES: Comments due within 30 days of 

publication. OMB must make a decision 

about the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. You can also obtain 

copies of the proposed collection of 

information by emailing. 

SUPPLEMENTARY INFORMATION: 

Description: Section 471(e)(4)(E) of 

the Social Security Act (the Act) (42 

U.S.C. 671), as amended by Public Law 

115–123, requires state and tribal child 

welfare agencies to collect and report to 

ACF information on children receiving 

prevention and family services and 

programs. Title IV–E Agencies must 

report the following on a bi-annual 

basis: 

• The specific services or programs 

provided 

• The total expenditures for each of the 

services or programs provided 

• The duration of the services or 

programs provided, and 

• If the child was identified in a 

prevention plan as a candidate for 

foster care: 

Æ The child’s placement status at the 

beginning, and at the end, of the 12- 

month period that begins on the 

date the child was identified as a 

candidate for foster care in a 

prevention plan; and 

Æ Whether the child entered foster 

care during the initial 12-month 

period and during the subsequent 

12-month period. 

To date, approximately 3⁄4 of the Title 

IV–E Agencies have chosen to provide 

these prevention services; however, it is 

believed that this number will continue 

to increase over time as states 

voluntarily opt-in to the program in 

order to utilize IV–E funding to provide 

prevention programs and services to 

children and families. 

The data collected will continue to 

inform federal policy decisions, 

program management, and responses to 

Congressional and Departmental 

inquiries. Specifically, the data will 

provide information about the use and 

availability of prevention services to 

children to prevent the need for foster 

care placement. The data contains 

personally identifiable information (date 

of birth and race/ethnicity). 

Respondents: Title IV–E Agencies. 

ANNUAL BURDEN ESTIMATES

Instrument 

Total 

number of 

respondents 

Annual 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual 

burden 

hours 

Prevention Services Data Collection ............................................................... 55 2 31 3,410 


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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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