Federal Register / Vol. 87, No. 133 / Wednesday, July 13, 2022 / Notices 41723 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2022–14932 Filed 7–12–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

[OMB #0970–0531] 

Submission for OMB Review; 

Formative Data Collections for ACF 

Program Support 

AGENCY: Office of Planning, Research, 

and Evaluation, Administration for 

Children and Families, HHS. 

ACTION: Request for public comment. 

SUMMARY: The Administration for 

Children and Families (ACF) plans to 

submit a request to the Office of 

Management and Budget (OMB) to 

extend approval of the existing 

overarching generic clearance for 

Formative Data Collections for ACF 

Program Support (OMB #0970–0531; 

expiration date 7/31/2022). ACF 

proposes minor updates to the 

description of potential generic 

information collections under the 

overarching generic and to the estimated 

number of respondents. 

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 

OPREinfocollection@acf.hhs.gov. 

Identify all requests by the title of the 

information collection. 

SUPPLEMENTARY INFORMATION: 

Description: The goals of the generic 

information collections under this 

approval are to obtain information about 

program and grantee processes or needs 

and to inform the following types of 

activities, among others: 

• Delivery of targeted assistance and/ 

or workflows related to program and 

grantee processes. This could include 

the development and refinement of 

recordkeeping and communication 

systems. 

• Planning for provision of 

programmatic or evaluation-related 

training or technical assistance (T/TA). 

• Obtaining input on the 

development of program performance 

measures from grantees or others with 

experience or vested interest. 

• Obtaining feedback about processes 

and/or practices to inform ACF program 

development or support, or ACF 

research. 

• Use of rapid-cycle testing activities 

to strengthen programs in preparation 

for summative evaluations. 

• Creating public resources with 

information about ACF-funded 

programs, systems, or activities. 

ACF uses a variety of techniques such 

as semi-structured discussions, focus 

groups, surveys, templates, open-ended 

requests, and telephone or in-person 

interviews in order to reach these goals. 

Information collected under this 

overarching generic is meant to inform 

ACF activities and may be incorporated 

into documents or presentations that are 

made public such as through conference 

presentations, websites, or social media. 

The following are some examples of 

ways in which we may share 

information resulting from these data 

collections: technical assistance plans, 

presentations, infographics, project 

specific reports, or other documents 

relevant to those involved with or 

interested in ACF programs such as 

federal leadership and staff, grantees, 

local implementing agencies, and/or T/ 

TA providers. 

Information may also be used to 

create public resources for users 

(clients, programs, researchers). 

Following standard OMB requirements, 

the Office of Planning, Research, and 

Evaluation will submit a change request 

for each individual data collection 

activity under this generic clearance. 

Each request will include the individual 

instrument(s), a justification specific to 

the individual information collection, 

and any supplementary documents. 

OMB should review requests within 10 

days of submission. 

The proposed types and the purpose 

of generic information collections 

submitted under this umbrella generic 

remain the same. Minor revisions are 

based on experiences over the past 3 

years. These include: 

• Updated burden estimates 

• Broadened the description to make 

clearer the intention to broadly include 

respondents with knowledge, 

experience, or interest in ACF programs 

to allow ACF to learn about needs and 

processes related to ACF programs from 

those not necessarily funded by ACF 

• Included specification about 

requesting information for efforts to 

consolidate publicly available 

information to build public resources 

for ACF programs, grantees, clients, or 

others who may use or be interested in 

services funded by ACF. 

Respondents: Example respondents 

include current or prospective service 

providers, training or T/TA providers, 

grantees, contractors, current and 

potential participants in ACF programs 

or similar comparison groups, experts in 

fields pertaining to ACF programs, key 

groups involved in ACF projects and 

programs, individuals engaged in 

program re-design or demonstration 

development for evaluation, state or 

local government officials, or others 

involved in or prospectively involved in 

ACF programs. 

Burden Estimates 

At the time of this extension request, 

30 GenICs are ongoing, with a total of 

13,652 burden hours. See Attachment B 

for a list of all previously approved, 

ongoing GenICs. The following 

estimates are specific to new collections 

over the next three years. 

Instrument 

Number of 

respondents 

(total over 

request 

period) 

Number of 

responses per 

respondent 

(total over 

request 

period) 

Average 

burden 

per response 

(in hours) 

Total burden 

(in hours) 

Semi-Structured Discussions and Focus Groups ............................................ 10,000 1 2 20,000 

Interviews ......................................................................................................... 4,500 1 1 4,500 

Questionnaires/Surveys ................................................................................... 8,000 1.5 .5 6,000 


jspears on DSK121TN23PROD with NOTICES1
41724 Federal Register / Vol. 87, No. 133 / Wednesday, July 13, 2022 / Notices 

Instrument 

Number of 

respondents 

(total over 

request 

period) 

Number of 

responses per 

respondent 

(total over 

request 

period) 

Average 

burden 

per response 

(in hours) 

Total burden 

(in hours) 

Templates and Open-ended Requests ........................................................... 1,000 1 10 10,000 

Estimated Total Annual Burden 

Hours: 40,500. 

Authority: Social Security Act, Sec. 

1110 [42 U.S.C. 1310]. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–14896 Filed 7–12–22; 8:45 am] 

BILLING CODE 4184–79–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2020–E–2361; FDA– 

2020–E–2362; and FDA–2020–E–2363] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ENSPRYNG 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for ENSPRYNG and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of applications to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of 

patents which claims that human 

biological product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by September 12, 2022. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicants for 

extension acted with due diligence 

during the regulatory review period by 

January 9, 2023. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

September 12, 2022. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

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 Nos. FDA– 

2020–E–2361; FDA–2020–E–2362; and 

FDA–2020–E–2363 for ‘‘Determination 

of Regulatory Review Period for 

Purposes of Patent Extension; 

ENSPRYNG.’’ 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 § 10.20 (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: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 


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