9854 Federal Register / Vol. 89, No. 29 / Monday, February 12, 2024 / Notices 

an article that appears violative, we 

provide notice to the owner or 

consignee of the nature of the violation 

and the right to present testimony 

regarding the admissibility of the article 

(21 CFR 1.94). Frequently, owners or 

consignees submit analytical test results 

based on samples taken from the article 

subject to DWPE as evidence 

demonstrating admissibility. We then 

determine if the testimony (analytical 

package, information, or other evidence) 

is sufficient. If the evidence is adequate 

to overcome the appearance of the 

violation(s), FDA will allow the article 

to proceed for entry into the United 

States. If the evidence is not adequate to 

remove the appearance of the 

violation(s), the entry will be refused 

admission into the United States. 

In addition, interested parties may 

request that their products be removed 

from DWPE. FDA decisions to remove a 

product, manufacturer, or other entity 

from DWPE are based on evidence 

establishing that the conditions that 

gave rise to the appearance of a 

violation have been resolved and we 

have confidence that future shipments 

of the product to the United States will 

be in compliance with the FD&C Act. 

FDA may consider analytical results 

from successful consecutive tests as part 

of the evidence to support removal from 

DWPE. 

The draft guidance, when finalized, 

will provide recommendations for 

collecting a representative sample for 

products subject to DWPE under an 

import alert due to the appearance of 

adulteration caused by pathogens, 

unlawful animal drugs, scombrotoxin 

(histamine), and/or decomposition. 

When finalized, the draft guidance will 

also help foreign manufacturers and 

other processors of fish and fishery 

products subject to DWPE introduce 

evidence to FDA to support a request to 

have products removed from DWPE. 

The recommendations in the draft 

guidance include sample sizes based on 

a critical nonconformities sampling 

strategy. Using this statistical sampling 

equation, the amount of sampling 

recommended can be structured 

commensurate with the level of 

concern, and risk to consumers, 

associated with the type of adulteration 

to be addressed. For more information, 

see ‘‘Derivation of Sampling 

Recommendations Related to 

Recommendations for Collecting 

Representative Samples for Food 

Testing Used as Evidence for Release of 

Certain Fish and Fishery Products 

Subject to Detention Without Physical 

Examination (DWPE) and Removal of a 

Foreign Manufacturer’s Goods from 

DWPE; Guidance for Industry’’ (Ref. 1). 

As the draft guidance makes clear, 

persons may propose alternative 

sampling plans and explain the basis for 

such alternatives. 

We note that the draft guidance refers 

to the final rule entitled ‘‘Laboratory 

Accreditation for Analyses of Foods’’ 

(LAAF Rule, which is codified at 21 

CFR part 1, subpart R). FDA is taking a 

stepwise approach to implementing the 

LAAF Rule based, in part, on reaching 

sufficient LAAF-accredited laboratory 

capacity for food testing (see 86 FR 

68728 at 68739 and 68740, December 3, 

2021). FDA may publish one or more 

documents in the Federal Register 

giving owners and consignees 6 months’ 

notice before requiring them to use a 

LAAF-accredited laboratory for food 

testing covered by the rule (id.). We will 

monitor LAAF Rule implementation 

and update any final guidance based on 

this draft guidance accordingly. 

II. Paperwork Reduction Act of 1995

While this guidance contains no

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information in 21 CFR part 1, subpart R 

have been approved under OMB control 

number 0910–0898. 

III. Electronic Access

Persons with access to the internet

may obtain the draft guidance at https:// 

www.fda.gov/FoodGuidances, https:// 

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. Use the 

FDA website listed in the previous 

sentence to find the most current 

version of the guidance. 

IV. Reference

The following reference is on display

at the Dockets Management Staff (see 

ADDRESSES) and is available for viewing 

by interested persons between 9 a.m. 

and 4 p.m., Monday through Friday; it 

is also available electronically at https:// 

www.regulations.gov. 

1. FDA, ‘‘Derivation of Sampling

Recommendations Related to

Recommendations for Collecting 

Representative Samples for Food Testing 

Used as Evidence for Release of Certain 

Fish and Fishery Products Subject to 

Detention Without Physical Examination 

(DWPE) and Removal of a Foreign 

Manufacturer’s Goods from DWPE; 

Guidance for Industry.’’ 

Dated: February 7, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–02838 Filed 2–9–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–4974] 

Advanced Manufacturing Technologies 

Designation Program; Draft Guidance 

for Industry; Availability; Agency 

Information Collection Activities; 

Proposed Collection; 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 entitled 

‘‘Advanced Manufacturing Technologies 

Designation Program; Draft Guidance for 

Industry; Availability; Agency 

Information Collection Activities; 

Proposed Collection; Comment 

Request’’ that appeared in the Federal 

Register of December 13, 2023. 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 document published on 

December 13, 2023 (88 FR 86333). 

Either electronic or written comments 

must be submitted by March 13, 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 13, 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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 29 / Monday, February 12, 2024 / Notices 9855 

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–D–4974 for ‘‘Advanced 

Manufacturing Technologies 

Designation Program.’’ 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. 

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: 

With regard to the draft guidance: 

Ranjani Prabhakara, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 6648, 

Silver Spring, MD 20993, 240–402– 

4652; 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. 

With regard to the proposed collection 

of information: 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: 

I. Background

In the Federal Register of December

13, 2023, FDA published a notice of 

availability with a 60-day comment 

period to provide comments on the draft 

guidance entitled ‘‘Advanced 

Manufacturing Technologies 

Designation Program’’ and its proposed 

collection of information. FDA has 

received requests to extend the 

comment period to allow sufficient time 

to develop and submit meaningful 

comments. FDA has considered the 

requests and is extending the comment 

period for 30 days, until March 13, 

2024. The Agency believes that this 

extension allows adequate time for 

interested persons to submit comments. 

II. Electronic Access

Persons with access to the internet

may obtain an electronic version of the 

draft guidance at https://www.fda.gov/ 

drugs/guidance-compliance-regulatoryinformation/guidances-drugs, https://

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: February 7, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–02836 Filed 2–9–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–0119] 

Fiscal Year 2024 Generic Drug Science 

and Research Initiatives Workshop; 

Public Workshop; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the following public 

workshop entitled ‘‘FY 2024 Generic 

Drug Science and Research Initiatives 

Workshop.’’ The purpose of the public 

workshop is to provide an overview of 

the status of science and research 

initiatives for generic drugs and an 

opportunity for public input on these 

initiatives. FDA is seeking this input 

from a variety of stakeholders— 


khammond on DSKJM1Z7X2PROD with NOTICES