27650 Federal Register / Vol. 87, No. 89 / Monday, May 9, 2022 / Notices 

Dated: May 3, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09887 Filed 5–6–22; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–1112] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Interstate Shellfish 

Dealer’s Certificate and Participation in 

the National Shellfish Sanitation 

Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by June 8, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0021. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

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: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Interstate Shellfish Dealer’s Certificate 

and Participation in the National 

Shellfish Sanitary Program 

OMB Control Number 0910–0021— 

Extension 

Under section 243 of the Public 

Health Service Act (42 U.S.C. 243), FDA 

is required to cooperate with and aid 

State and local authorities in the 

enforcement of their health regulations 

and is authorized to assist States in the 

prevention and suppression of 

communicable diseases. Under this 

authority, FDA participates with State 

regulatory agencies, some foreign 

nations, and the U.S. molluscan 

shellfish industry in the National 

Shellfish Sanitation Program (NSSP). 

The NSSP is a voluntary, cooperative 

program to promote the safety of 

molluscan shellfish by providing for the 

classification and patrol of shellfish 

growing waters and for the inspection 

and certification of shellfish dealers. 

Each participating State and foreign 

nation monitors its molluscan shellfish 

production and issues certificates for 

those dealers that meet the State or 

foreign shellfish control authority’s 

criteria. Each participating State and 

nation provides a certificate of its 

certified shellfish dealers to FDA on 

Form FDA 3038, ‘‘Interstate Shellfish 

Dealer’s Certificate’’ (available at 

https://www.fda.gov/media/72094/ 

download). FDA uses this information 

to publish the ‘‘Interstate Certified 

Shellfish Shippers List (ICSSL),’’ a 

monthly comprehensive listing of all 

molluscan shellfish dealers certified 

under the cooperative program 

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

federalstate-food-programs/interstatecertified-shellfish-shippers-list). If FDA 

did not collect the information 

necessary to compile this list, 

participating States would not be able to 

identify and prevent the distribution in 

the United States of shellfish processed 

by uncertified dealers. Consequently, 

the NSSP would not be able to control 

the distribution of uncertified and 

possibly unsafe shellfish in interstate 

commerce. Without the ICSSL, the 

effectiveness of the NSSP would be 

nullified. The ICSSL is also used to 

identify U.S. shellfish dealers eligible to 

obtain health certificates and export to 

certain countries or regions. 

FDA has been collecting information 

to construct the ICSSL since 2001. FDA 

is seeking to add one new data field to 

Form FDA 3038, the ‘‘FDA 

Establishment Identifier’’ (FEI number). 

The FEI number is a unique number 

assigned by FDA to identify FDAregulated facilities. FDA will explore 

whether the FEI can be used to retrieve 

data on shellfish dealers from existing 

FDA systems, which could reduce the 

number of required data elements that 

firms have to submit on Form FDA 

3038. 

The information collection also 

includes providing certain documents 

demonstrating compliance with the 

NSSP. When a competent authority in 

another country conducts an evaluation 

to determine whether the U.S. food 

safety control measures for molluscan 

shellfish are equivalent to their system 

of controls, the competent authority 

may require FDA to provide information 

and records demonstrating compliance 

with the provisions of the NSSP. Only 

those firms that comply with the NSSP 

would be permitted to export molluscan 

shellfish to a country whose competent 

authority determined that the U.S. 

system of controls is equivalent to their 

own controls. FDA uses this information 

to support the export of U.S. shellfish to 

countries whose competent authorities 

have determined the U.S. system of food 

safety controls to be equivalent to their 

own system of controls by 

demonstrating that the exporter is in 

compliance with the U.S. system of 

controls specified in the NSSP. 

For example, to implement the 

European Commission’s (EC) 

determination that the U.S. system of 

food safety controls for raw bivalve 

molluscan shellfish is equivalent to the 

European Union’s (EU) system of 

controls, the EC is requiring FDA to 

provide documentation collected from 

NSSP-participating shellfish control 

authorities with firms seeking to export 

raw molluscan shellfish to the EU. This 

documentation includes, but is not 

limited to: 

• A list of growing areas with an 

Approved classification; 

• the most recent sanitary survey for 

each growing area with an Approved 

classification; and 

• the most recent inspection report 

for each firm seeking to export shellfish 

to the EU. 

Some competent authorities may 

require additional information to 

conduct an equivalence assessment or to 

implement an equivalence 

determination, or both. We plan to 

provide respondents with information 

about the specific documentation that is 

required for each equivalence 

assessment. For those competent 

authorities that recognize the U.S. 

system as equivalent, additional 

documentation may be needed to 

implement that determination. 

Description of Respondents: 

Respondents to this collection are 

participating State and local regulatory 

agencies and foreign nations. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 89 / Monday, May 9, 2022 / Notices 27651 

In the Federal Register of November 

4, 2022 (86 FR 60840), 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 BURDEN 1

Activity Form FDA No. Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

Submission of Interstate Shellfish 

Dealer’s Certificate.

3038 40 57 2,280 0.10 (6 minutes) ........ 228 

Submission of Other Records Related to Participation in the 

NSSP.

N/A 13 1 13 0.25 (15 minutes) ...... 3.25 

Total ...................................... ........................ ........................ ........................ ........................ .................................... 231.25 

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

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

This estimate is based on our experience 

with this information collection and the 

number of certificates received in the 

past 3 years, which has remained 

constant. 

Dated: May 2, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09888 Filed 5–6–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Notice of Interest Rate on Overdue 

Debts 

Section 30.18 of the Department of 

Health and Human Services’ claims 

collection regulations (45 CFR part 30) 

provides that the Secretary shall charge 

an annual rate of interest, which is 

determined and fixed by the Secretary 

of the Treasury after considering private 

consumer rates of interest on the date 

that the Department of Health and 

Human Services becomes entitled to 

recovery. The rate cannot be lower than 

the Department of Treasury’s current 

value of funds rate or the applicable rate 

determined from the ‘‘Schedule of 

Certified Interest Rates with Range of 

Maturities’’ unless the Secretary waives 

interest in whole or part, or a different 

rate is prescribed by statute, contract, or 

repayment agreement. The Secretary of 

the Treasury may revise this rate 

quarterly. The Department of Health and 

Human Services publishes this rate in 

the Federal Register. 

The current rate of 93⁄8%, as fixed by 

the Secretary of the Treasury, is certified 

for the quarter ended March 31, 2022. 

This rate is based on the Interest Rates 

for Specific Legislation, ‘‘National 

Health Services Corps Scholarship 

Program (42 U.S.C. 254o(b)(1)(A))’’ and 

‘‘National Research Service Award 

Program (42 U.S.C. 288(c)(4)(B)).’’ This 

interest rate will be applied to overdue 

debt until the Department of Health and 

Human Services publishes a revision. 

David C. Horn, 

Director, Office of Financial Policy and 

Reporting. 

[FR Doc. 2022–09840 Filed 5–6–22; 8:45 am] 

BILLING CODE 4150–04–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0937–0166] 

Agency Information Collection 

Request. 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before June 8, 2022. 

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. 

FOR FURTHER INFORMATION CONTACT: 

Sherrette Funn, Sherrette.Funn@hhs.gov 

or (202) 795–7714. When submitting 

comments or requesting information, 

please include the document identifier 

0937–0166 and project title for 

reference. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: 42 CFR 

Subpart B: Sterilization of Persons in 

Federally Assisted Family Planning 

Projects. 

Type of Collection: Reinstatement 

without change. 

OMB No. 0937–0166 

Abstract: The Office of Population 

Affairs (OPA), Office of the Assistant 

Secretary for Health, requests a 

reinstatement without change of a 

currently approved collection for the 

disclosure and recordkeeping 

requirements codified at 42 CFR part 50, 

subpart B (‘‘Sterilization of Persons in 

Federally Assisted Family Planning 

Projects’’). The consent form solicits 

information to assure voluntary and 

informed consent to persons undergoing 

sterilization in programs of health 

services which are supported by federal 

financial assistance administered by the 

PHS. It provides additional procedural 

protection to the individual and the 

regulation requires that the consent 

form be a copy of the form that is 

appended to the PHS regulation. In 

2003, the PHS sterilization consent form 

was revised to conform to OMB 

government-wide standards for the 


khammond on DSKJM1Z7X2PROD with NOTICES