Federal Register / Vol. 89, No. 33 / Friday, February 16, 2024 / Notices 12353 

with diverse experiences and 

perspectives to inform ACF policies and 

programs. The information collected 

would allow for ongoing, two-way 

collaborative and actionable 

communications between ACF and its 

State, local and/or Tribal partners, 

program participants, communities 

served or affected by ACF programs, and 

or others experienced with or interested 

in ACF programs or similar programs. 

ACF envisions using information 

collected to inform a variety of efforts 

and activities such as the improvement, 

planning, and implementation of 

research studies, program changes, 

development and dissemination of 

resources and products developed 

under ACF studies, regulatory activities, 

guidance, outreach and/or training 

activities. The specific types of 

information gathering methods included 

under the umbrella of this clearance 

will vary, but will use well-established 

methodologies, including but not 

limited to: 

• Semi-structured discussions or 

conference calls 

• Focus groups 

• Telephone or in-person interviews 

• Questionnaires/Surveys 

• Roundtable and/or Breakout Sessions 

• Open-ended requests 

• Contextualizing Existing Data 

Data collection will take place 

through a variety of activities—both inperson and virtual—dependent on the 

specific project. ACF will submit 

individual requests under this 

clearance. ACF requests OMB provide a 

response on individual generic 

information collections within 10 

business days. 

Respondents: Respondents could 

include current or prospective service 

providers, training and technical 

assistance providers, grant recipients, 

contractors, current and potential 

participants in ACF programs or other 

comparable groups and other 

individuals with lived experience with 

ACF or similar programs, experts in 

fields pertaining to ACF programs, other 

key groups involved in ACF projects 

and programs, individuals engaged in 

program re-design or demonstration 

development for evaluation, State or 

local government officials, those in 

broader fields of study related to human 

services, or others involved in or 

prospectively involved in ACF 

programs. 

Burden Estimates: The burden table 

below is illustrative. Estimates for the 

number of respondents and time per 

response have been made based on 

discussion with ACF program offices, 

but as this is a new umbrella generic, it 

may be possible that we will need to 

adjust estimates throughout the threeyear approval period. If needed, ACF 

will submit a change request for these 

updates. While we will not exceed the 

total burden cap for this generic without 

requesting a change for updates, we may 

use more or less burden within each 

instrument type. 

Example types of information collections 

Total 

number of 

respondents 

Total 

number of 

responses per 

respondent 

Average 

burden 

hours per 

response 

Total 

burden 

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 

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

Estimated Totals ..................................................................................................... 23,500 ........................ .................... 40,500 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–03228 Filed 2–15–24; 8:45 am] 

BILLING CODE 4184–88–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–5259] 

Master Protocols for Drug and 

Biological Product Development; Draft 

Guidance for Industry; Extension of 

Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; extension 

of comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

extending the comment period for the 

notice of availability that published in 

the Federal Register of December 22, 

2023. In that notice, FDA requested 

comments on the draft guidance for 

industry entitled, ‘‘Master Protocols for 

Drug and Biological Product 

Development.’’ The Agency is taking 

this action in response to requests for an 

extension to allow interested persons 

additional time to submit comments. 

DATES: FDA is extending the comment 

period on the draft guidance published 

December 22, 2023 (88 FR 88623). 

Submit either electronic or written 

comments by March 21, 2024, to ensure 

that the Agency considers your 

comments on this draft guidance before 

it begins work on the final version of the 

guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

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 


lotter on DSK11XQN23PROD with NOTICES1
12354 Federal Register / Vol. 89, No. 33 / Friday, February 16, 2024 / Notices 

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– 

2023–D–5259 for ‘‘Master Protocols for 

Drug and Biological Product 

Development.’’ Received comments 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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; or the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Scott N. Goldie, Center for Drug 

Evaluation and Research, Office of 

Biostatistics, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 21, Rm. 3557, Silver Spring, 

MD 20993–0002, 301–796–2055; or 

James Myers Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of December 22, 2023, 

FDA published a notice of availability 

for a draft guidance entitled, ‘‘Master 

Protocols for Drug and Biological 

Product Development.’’ This action 

opened a docket with a 60-day comment 

period. The Agency received requests 

for an extension of the comment period 

for the draft guidance. After considering 

the requests, and in light of the fact that 

the original comment period is 

scheduled to close on February 20, 

2024, FDA has decided to extend the 

comment period for 30 days, until 

March 21, 2024. The Agency believes 

that this extension allows adequate time 

for interested persons to submit 

comments to ensure that FDA can 

consider the comments before it begins 

work on the final version of the 

guidance. 

Dated: February 13, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–03296 Filed 2–15–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] 

Product-Specific Guidances; Draft and 

Revised Draft Guidances for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of 

additional draft and revised draft 

product-specific guidances. The 

guidances provide product-specific 

recommendations on, among other 

things, the design of bioequivalence 

(BE) studies to support abbreviated new 

drug applications (ANDAs). In the 

Federal Register of June 11, 2010, FDA 

announced the availability of a guidance 

for industry entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products’’ that explained the process 

that would be used to make productspecific guidances available to the 

public on FDA’s website. The guidances 

identified in this notice were developed 

using the process described in that 

guidance. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by April 16, 2024 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

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. 


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