1100 Federal Register / Vol. 89, No. 6 / Tuesday, January 9, 2024 / Notices 

the extralabel use of the drug, and to 

require the development of an analytical 

method for the detection of residues 

above that established safe level. This 

requirement is codified at § 530.22(b) 

(21 CFR 530.22(b)). 

Although to date, we have not 

established a safe level for a residue 

from the extralabel use of any new 

animal drug and, therefore, have not 

required the development of analytical 

methodology, we believe that there may 

be instances when analytical 

methodology will be required. We are, 

therefore, estimating the reporting 

burden based on two methods being 

required annually. The requirement to 

establish an analytical method may be 

fulfilled by any interested person. We 

believe that the sponsor of the drug will 

be willing to develop the method in 

most cases. Alternatively, FDA, the 

sponsor, and perhaps a third party may 

cooperatively arrange for method 

development. Respondents to the 

information collection are private sector 

drug sponsors or veterinary 

associations, or veterinarians, State, 

local, and tribal governments, and 

Federal Agencies. 

In the Federal Register of August 31, 

2023 (88 FR 60213), FDA 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

21 CFR Section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total 

hours 

530.22(b); Submission(s) of analytical method ................... 2 1 2 4,160 8,320 

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. 

Dated: January 4, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–00219 Filed 1–8–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3490] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Application for 

Participation in Food and Drug 

Administration Fellowship and 

Traineeship Programs 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, 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 

(PRA). 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by February 8, 

2024. 

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 0910–0780. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, 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. 

Application for Participation in FDA 

Fellowship and Traineeship Programs 

OMB Control Number 0910–0780— 

Extension 

This information collection supports 

FDA fellowship and traineeship 

programs. Sections 1104, 1302, 3301, 

3304, 3320, 3361, 3393, and 3394 of 

Title 5 of the United States Code 

authorize Federal Agencies to rate 

applicants for Federal jobs. The 

information collection involves brief 

online applications completed by 

applicants applying to FDA’s 

Fellowship and Traineeship programs. 

These voluntary online applications 

will allow the Agency to easily and 

efficiently elicit and review information 

from students and healthcare 

professionals who are interested in 

becoming involved in FDA-wide 

activities. The process will reduce the 

time and cost of submitting written 

documentation to the Agency and lessen 

the likelihood of applications being 

misrouted within the Agency mail 

system. It will assist the Agency in 

promoting and protecting the public 

health by encouraging outside persons 

to share their expertise with FDA. 

In the Federal Register of September 

19, 2023 (88 FR 64438), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. We received two 

comments, which were not PRA related 

and will not be addressed in this 

document. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Medical Device Fellowship Program ................................... 250 1 250 1 250 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 6 / Tuesday, January 9, 2024 / Notices 1101 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued 

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

FDA Traineeship Program ................................................... 1,000 1 1,000 1 1,000 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,250 

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. 

Dated: January 4, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–00220 Filed 1–8–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4804] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Expedited 

Programs for Serious Conditions— 

Drugs and Biologics 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection pertaining to ‘‘Expedited 

Programs for Serious Conditions—Drugs 

and Biologics.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 11, 2024. 

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 

March 11, 2024. 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 No. FDA– 

2023–N–4804 for ‘‘Expedited Programs 

for Serious Conditions—Drugs and 

Biologics.’’ 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 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: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 


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