Federal Register / Vol. 89, No. 217 / Friday, November 8, 2024 / Notices 88785 

disability networks will be analyzed to 

determine resource needs in legal 

subject matter areas and systems 

development topics indicated by the 

target audience. The information 

collected will be used by ACL and the 

Contract Officer Representative (COR) to 

tailor the resource support provided 

through the NCLER contract to the 

ongoing and emerging priority needs of 

aging and disability networks. 

To determine effectiveness in 

reaching intended target audience: The 

NCLER contract and OAA section 420(a) 

requires that support services are 

provided to specific groups of providers 

within the aging and disability 

networks. The audience in need of 

comprehensive resource support 

through NCLER includes a broad range 

of legal, elder rights, and aging/ 

disability services professionals, 

advocates, and organizations. These 

include legal assistance providers, legal 

assistance developers, long-term care 

ombudsmen, adult protective services, 

state units on aging, area agencies on 

aging, aging and disability resource 

centers, and others involved in 

protecting the legal rights of older 

persons. The information collected on 

requests for resource support from aging 

and disability networks will be 

reviewed and analyzed by ACL and the 

COR to determine whether the 

appropriate target audiences are 

requesting and receiving resource 

support through NCLER. ACL and the 

COR will also use the information to 

determine if the use of resource support 

through NCLER by intended target 

audiences is increasing at a set 

percentage annually in compliance with 

contractual performance indicators. 

To determine the quality of legal 

resource support provided: The NCLER 

contract performance indicators require 

that the quality of resource support 

provided be measured through 

voluntary recipient feedback. The 

Contractor is required to assure that a 

set percentage of recipients of resource 

support responding to evaluative tools 

will rate the quality of the assistance 

provided as good to excellent. The 

Contractor will have processes in place 

to ensure the integrity of information 

received by target audience. The 

information collected on quality of 

resource support received by target 

audiences will be analyzed by ACL and 

the COR to determine whether 

minimum performance standards are 

met and whether necessary actions need 

to be taken to improve the quality of 

resource support provided through 

NCLER. 

To determine the usefulness of 

resource support provided: The NCLER 

contract performance indicators require 

the anticipated usefulness of resource 

support provided be measured through 

voluntary recipient feedback. The 

Contractor is required to assure that a 

set percentage of recipients of resource 

support responding to evaluative tools 

will agree or strongly agree that the 

assistance provided contributed to the 

successful resolution of a specific legal 

issue. 

The information collected on the 

usefulness of resource support received 

by target audiences will be analyzed by 

ACL and the COR to determine whether 

minimum performance standards are 

met and whether necessary actions need 

to be taken to improve the practical 

usefulness of resource support provided 

through NCLER. 

The data collected will be reviewed 

by the COR on monthly basis through 

contractually required monthly reports 

provided by NCLER. Review of the data 

will be the focus of monthly calls with 

the Contractor to guide ongoing program 

improvements and adjustments as 

directed by the COR. The data will also 

be incorporated into the contractually 

required Summary of Stakeholder Input 

Document (SSID) designed to guide the 

ongoing evolution and improvement of 

NCLER into subsequent contract option 

years. The data will also be compiled in 

a final annual report provided by the 

Contractor and reviewed by the COR 

against the QUASP to determine 

contractual compliance. 

This IC does not collect demographic 

data from grantees receiving programs 

and services funded by HHS. This 

includes guidance specific to the 

collection of sexual orientation and 

gender identity items that align with 

Executive Order 13985 on Advancing 

Racial Equity and Support for 

Underserved Communities Through the 

Federal Government, Executive Order 

14075 on Advancing Equality for 

Lesbian, Gay, Bisexual, Transgender, 

Queer, and Intersex Individuals, and 

Executive Order 13988 on Preventing 

and Combating Discrimination on the 

Basis of Gender Identity and Sexual 

Orientation, and the updated Statistical 

Policy Directive No. 15: Standards for 

Maintaining, Collecting, and Presenting 

Federal Data on Race and Ethnicity 

(effective March 28, 2024). 

The proposed data collection tools 

may be found on the ACL website for 

review at: https://www.acl.gov/aboutacl/public-input. 

Estimates of Burden: Burden 

calculation for each category of 

information: 

Respondent/data collection activity Number of 

respondents Minutes per response Annual burden hours 

Resource Support Requests .......................................................... 80 2 .................................................................. 2.53 

Legal Training, Case Consultation, Technical Assistance Requests-User Satisfaction.14,000 2 .................................................................. 397 

Total ........................................................................................ 14,080 4 min 39 sec ............................................... 399.53 hours 

Dated: November 4, 2024. 

Maura Calsyn, 

Principal Deputy Administrator for the 

Administration for Community Living, 

performing the delegable duties of the 

Administrator and the Assistant Secretary for 

Aging. 

[FR Doc. 2024–25931 Filed 11–7–24; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4776] 

Export Lists for Human Food: Request 

for Information 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for information. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) invites comment relating to the 

listing requirements of other countries 

and FDA’s approach to facilitating U.S. 

industry compliance with these 

requirements through the issuance of 

export certification for human food 

products provided in the form of lists 

(export lists). 

DATES: Submit either electronic or 

written comments on the request for 


ddrumheller on DSK120RN23PROD with NOTICES1
88786 Federal Register / Vol. 89, No. 217 / Friday, November 8, 2024 / Notices 

information by January 7, 2025 to 

ensure that the Agency considers your 

comment. 

ADDRESSES: You may submit comments 

in the following way: 

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– 

2024–N–4776 for ‘‘Export Lists for 

Human Food: Request for Information.’’ 

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.’’ We 

will review this copy, including the 

claimed confidential information, in our 

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: 

Peter Fricke, Human Foods Program, 

Office of International Engagement, 

Food and Drug Administration, 5001 

Campus Dr., College Park, MD 20740, 

240–402–2307. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under section 801(e)(4)(A) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 381(e)(4)(A)), any 

person who exports a food, drug, animal 

drug, or device may request that FDA: 

• certify in writing that the exported 

food, drug, animal drug, or device meets 

the requirements of section 801(e)(1) or 

section 802 of the FD&C Act (21 U.S.C. 

382) or 

• certify in writing that the food, 

drug, animal drug, or device being 

exported meets the applicable 

requirements of the FD&C Act upon a 

showing that the food, drug, or device 

meets the applicable requirements of the 

FD&C Act. 

If we issue a written export 

certification within 20 days, we may 

then charge a fee up to $175 for each 

certification (see section 801(e)(4)(B) of 

the FD&C Act). The statute also 

authorizes us to issue certifications on 

a basis and in a form that we determine 

to be appropriate and expressly 

mentions publicly available listing as a 

form of certification (see section 

801(e)(4)(C) of the FD&C Act). 

Regarding export certification for 

human foods, FDA issues various types 

of export certificates and certification in 

the form of export lists. (For more 

information on the types of export 

certificates we issue for human foods, 

see https://www.fda.gov/food/exportingfood-products-united-states/foodexport-certificates.) To request inclusion 

on an export list, parties can use our 

Export Listing Module, which can be 

accessed through our website at https:// 

www.access.fda.gov/. Certification in 

the form of export lists is an intensive 

process due to both the development of 

a mutually acceptable listing procedure 

with foreign countries and then the 

maintenance of the export lists. FDA 

provides such certification to help 

ensure foreign market access for U.S. 

exporters of FDA-regulated food 

products. FDA export certification 

provides information concerning a 

product’s regulatory status, often 

including information about the 

establishment in which the product was 

manufactured, packaged, prepared and/ 

or held, based on available information 

at the time FDA issues the certification 

(including, as appropriate, attestations 

provided by the person seeking the 

export certification). In many cases, 

foreign governments are seeking official 

assurance that products exported from 

the United States to their countries can 

be marketed in the United States or that 

the products meet specific U.S. 

regulations, for example, as applicable, 

current good manufacturing practice 

regulations. A foreign government may 

also require export certification as part 

of the process to register or import a 

product into that country. 

FDA does not currently charge firms 

to be included on export lists for human 

food, but as authorized by the FD&C 

Act, we are considering charging fees for 

our export list services to offset our 

costs. As of August 2024, we provide 

certification in the form of export lists 

that cover 19 categories of products for 

six destinations: Chile, China, the 

European Union, Saudi Arabia, Taiwan, 

and the United Kingdom. 

To better inform the continuing 

development of our export list program 

for human foods, we invite public 

comment on the following: 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 217 / Friday, November 8, 2024 / Notices 88787 

• There are many different types of 

establishment listing and certification 

procedures for establishments that 

produce human food products. Please 

share your experience with other 

countries’ establishment listing, 

certification, and registration 

requirements. 

• FDA requires those on export lists 

to reapply regularly if they wish to 

remain listed. Do reapplicants 

experience any challenges with the 

renewal process? If you have 

experienced challenges, how were those 

challenges resolved? 

• For those included on export lists, 

please describe any challenges you have 

experienced with exporting human food 

products included on the export lists. 

• FDA is authorized to collect up to 

$175 per certification for each company 

and its human food products that FDA 

certifies through inclusion on an export 

list. For those that would be charged a 

fee, do you have any specific 

suggestions about how FDA should 

approach the implementation of fees? 

Please provide details relating to any 

suggestions you might have. 

Dated: November 4, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–26040 Filed 11–7–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4734] 

Amending Over-the-Counter 

Monograph M012: Cold, Cough, 

Allergy, Bronchodilator, and 

Antiasthmatic Drug Products for Overthe-Counter Human Use 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability on its website of the 

proposed administrative order 

(proposed order) (OTC000036) entitled 

‘‘Amending Over-the-Counter 

Monograph M012: Cold, Cough, Allergy, 

Bronchodilator, and Antiasthmatic Drug 

Products for Over-the-Counter Human 

Use.’’ This proposed order, if finalized, 

will amend Final Administrative Order 

OTC000026, to remove orally 

administered phenylephrine 

hydrochloride and phenylephrine 

bitartrate in an effervescent dosage as 

nasal decongestant active ingredients 

because they are not effective. 

DATES: Submit electronic comments on 

the proposed administrative order by 

May 7, 2025. 

ADDRESSES: The https://

www.regulations.gov electronic filing 

system will accept comments until 

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

May 7, 2025. Please note that late, 

untimely filed comments will not be 

considered. Instructions for submitting 

comments are contained in the 

proposed order OTC000036, which can 

be viewed in the OTC Monographs@

FDA portal at https://dps.fda.gov/omuf. 

Comments must be submitted 

electronically. 

FOR FURTHER INFORMATION CONTACT: Dan 

Brum, Center for Drug Evaluation and 

Research (HFD–600), Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–0578. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is issuing this proposed order 

OTC000036 to amend the requirements 

for cold, cough, allergy, bronchodilator, 

and antiasthmatic drug products for 

over-the-counter (OTC) human use, as 

currently described in Over-the-Counter 

Monograph M012: Cold, Cough, Allergy, 

Bronchodilator, and Antiasthmatic Drug 

Products for Over-the-Counter Human 

Use (OTC Monograph M012), as set 

forth in the Final Administrative Order 

OTC000026. FDA is issuing the 

proposed order pursuant to section 

505G(b)(1) of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

355h(b)(1)). 

OTC Monograph M012 describes the 

conditions under which OTC cold, 

cough, allergy, bronchodilator, and 

antiasthmatic drug products are 

generally recognized as safe and 

effective. OTC Monograph M012 is set 

forth in Final Administrative Order 

OTC000026, which was deemed 

established by section 505G(b)(8) of the 

FD&C Act, and was effective upon 

enactment of the Coronavirus Aid, 

Relief, and Economic Security Act (Pub. 

L. 116–136) on March 27, 2020. The 

conditions described in OTC 

Monograph M012, as set forth in final 

order(s), may be amended, revoked, or 

otherwise modified in accordance with 

the procedures of section 505G(b) of the 

FD&C Act. 

The proposed order, if finalized, will 

amend the conditions described in OTC 

Monograph M012 as set forth in the 

Final Administrative Order OTC000026 

to remove orally administered 

phenylephrine hydrochloride and 

phenylephrine bitartrate in an 

effervescent dosage from OTC 

Monograph M012 as nasal decongestant 

active ingredients because they are not 

effective. This proposed order also 

includes minor stylistic and formatting 

changes to improve the readability and 

presentation of OTC Monograph M012, 

including removing references to 

historical Federal Register documents 

because OTC monographs are no longer 

modified through notice and comment 

rulemaking. 

The proposed order can be viewed in 

the OTC Monographs@FDA portal at 

https://dps.fda.gov/omuf. The proposed 

order contains instructions for 

commenting on the proposed order. 

Comments to the proposed order must 

be submitted electronically to the 

Federal eRulemaking Portal at https://

www.regulations.gov. 

OTC Monographs@FDA provides a 

resource for the public to view 

Administrative Orders (Proposed, Final, 

and Interim Final Orders) for OTC 

Monograph Drugs and view OTC 

Monographs. In the future, OTC 

Monographs@FDA will facilitate the 

public’s ability to submit, search, and 

view comments and data for Proposed 

and Interim Final Orders. 

II. Paperwork Reduction Act of 1995 

The proposed order is issued under 

section 505G(b)(1) of the FD&C Act. 

Under section 505G(o) of the FD&C Act, 

the Paperwork Reduction Act of 1995 

(PRA) (Chapter 35 of title 44, United 

States Code) does not apply to 

collections of information made under 

section 505G of the FD&C Act. 

Therefore, clearance by the Office of 

Management and Budget under the PRA 

is not required for collections of 

information, if any, in a final order 

issued under section 505G of the FD&C 

Act that results from this proposed 

order. 

Dated: October 31, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–25910 Filed 11–7–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–new] 

Agency Information Collection 

Request; 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 


ddrumheller on DSK120RN23PROD with NOTICES1