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. 


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