65172 Federal Register / Vol. 88, No. 182 / Thursday, September 21, 2023 / Notices 

9The applicant has 15 days from the submittal of 

a motion to intervene to file a written objection to 

the intervention. 

10 18 CFR 385.214(c)(1). 

11 18 CFR 385.214(b)(3) and (d). 

your interest in the proceeding. For an 

individual, this could include your 

status as a landowner, ratepayer, 

resident of an impacted community, or 

recreationist. You do not need to have 

property directly impacted by the 

project in order to intervene. For more 

information about motions to intervene, 

refer to the FERC website at https://

www.ferc.gov/resources/guides/how-to/ 

intervene.asp. 

There are two ways to submit your 

motion to intervene. In both instances, 

please reference the Project docket 

number CP23–536–000 in your 

submission. 

(1) You may file your motion to 

intervene by using the Commission’s 

eFiling feature, which is located on the 

Commission’s website (www.ferc.gov) 

under the link to Documents and 

Filings. New eFiling users must first 

create an account by clicking on 

‘‘eRegister.’’ You will be asked to select 

the type of filing you are making; first 

select ‘‘General’’ and then select 

‘‘Intervention.’’ The eFiling feature 

includes a document-less intervention 

option; for more information, visit 

https://www.ferc.gov/docs-filing/efiling/ 

document-less-intervention.pdf.; or 

(2) You can file a paper copy of your 

motion to intervene, along with three 

copies, by mailing the documents to the 

address below. Your motion to 

intervene must reference the Project 

docket number CP23–536–000. 

To file via USPS: Kimberly D. Bose, 

Secretary, Federal Energy Regulatory 

Commission, 888 First Street NE, 

Washington, DC 20426. 

To file via any other courier: Kimberly 

D. Bose, Secretary, Federal Energy 

Regulatory Commission, 12225 Wilkins 

Avenue, Rockville, Maryland 20852. 

The Commission encourages 

electronic filing of motions to intervene 

(option 1 above) and has eFiling staff 

available to assist you at (202) 502–8258 

or FercOnlineSupport@ferc.gov. 

Protests and motions to intervene 

must be served on the applicant either 

by mail or email at: Matt Everngam, 

Director, Regulatory Affairs, Eastern 

Shore Natural Gas Company, 500 Energy 

Lane, Suite 200, Dover, DE 19901 or by 

email to meverngam@chpk.com. Any 

subsequent submissions by an 

intervenor must be served on the 

applicant and all other parties to the 

proceeding. Contact information for 

parties can be downloaded from the 

service list at the eService link on FERC 

Online. Service can be via email with a 

link to the document. 

All timely, unopposed 9 motions to 

intervene are automatically granted by 

operation of Rule 214(c)(1).10 Motions to 

intervene that are filed after the 

intervention deadline are untimely, and 

may be denied. Any late-filed motion to 

intervene must show good cause for 

being late and must explain why the 

time limitation should be waived and 

provide justification by reference to 

factors set forth in Rule 214(d) of the 

Commission’s Rules and Regulations.11

A person obtaining party status will be 

placed on the service list maintained by 

the Secretary of the Commission and 

will receive copies (paper or electronic) 

of all documents filed by the applicant 

and by all other parties. 

Tracking the Proceeding 

Throughout the proceeding, 

additional information about the project 

will be available from the Commission’s 

Office of External Affairs, at (866) 208– 

FERC, or on the FERC website at 

www.ferc.gov using the ‘‘eLibrary’’ link 

as described above. The eLibrary link 

also provides access to the texts of all 

formal documents issued by the 

Commission, such as orders, notices, 

and rulemakings. 

In addition, the Commission offers a 

free service called eSubscription which 

allows you to keep track of all formal 

issuances and submittals in specific 

dockets. This can reduce the amount of 

time you spend researching proceedings 

by automatically providing you with 

notification of these filings, document 

summaries, and direct links to the 

documents. For more information and to 

register, go to www.ferc.gov/docs-filing/ 

esubscription.asp. 

Intervention Deadline: 5:00 p.m. 

Eastern Time on October 6, 2023. 

Dated: September 15, 2023. 

Kimberly D. Bose, 

Secretary. 

[FR Doc. 2023–20456 Filed 9–20–23; 8:45 am] 

BILLING CODE 6717–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–0001] 

Menopause: Potential Impact on 

Clinical Pharmacology and 

Opportunities for Future Research; 

Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA) Office of 

Women’s Health and Office of Clinical 

Pharmacology is announcing the 

following public workshop: 

‘‘Menopause: Potential Impact on 

Clinical Pharmacology and 

Opportunities for Future Research.’’ The 

purpose of the public workshop is to 

discuss the current understanding of the 

impact of menopause on the 

pharmacokinetics (PK), 

pharmacodynamics (PD), and exposureresponse relationships of FDA-regulated 

drugs and biologics used by menopausal 

women for non-menopause-related 

indications. Researchers, educators, 

clinicians, and patients may benefit 

from attending this scientific workshop. 

Presentations will discuss whether 

changes in drug absorption, 

distribution, metabolism, and 

elimination, if any, could be affected by 

hormonal changes of menopause 

(independent of age), or other nonhormonal influences (including agerelated renal and hepatic changes). The 

discussion is further intended to 

identify the research and data gaps 

regarding the potential impact of 

menopause on PK/PD. Speakers will 

highlight areas with the greatest need 

for further research and exploration. 

DATES: The public workshop will be 

held virtually on October 11, 2023, from 

10 a.m. to 2 p.m. Eastern Time. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public workshop will 

be held virtually using the Zoom 

platform. The link for the public 

workshop will be sent to registrants 

upon registration. 

FOR FURTHER INFORMATION CONTACT: Lisa 

Lineberger, Food and Drug 

Administration, Office of the 

Commissioner, Office of Women’s 

Health, Bldg. 32, Rm. 2333, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993, 301–796–8751, OWHmeetings@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 182 / Thursday, September 21, 2023 / Notices 65173 

I. Background 

Menopause is often a time of 

tremendous transition and change for 

women. The effects of menopause on 

the PK and PD of drugs are largely 

unknown. Sex hormone changes during 

menopause may affect the metabolic 

pathways of drugs by affecting drug 

metabolizing enzymes. Hormone 

changes may also affect other pathways 

that play an important role for drug 

disposition and excretion. In addition, 

many women experience weight gain at 

menopause. Together, these changes 

associated with menopausal transition 

have the potential to affect the PK of 

medications used for indications not 

related to menopause. Furthermore, 

physiologic changes in menopause may 

result in altered sensitivity to drug 

response independent of changes in PK. 

This public workshop will provide 

insight into identifying the research and 

data gaps regarding the potential impact 

of menopause on PK/PD, highlighting 

areas with the greatest need for further 

research and exploration. 

II. Topics for Discussion at the Public 

Workshop 

This public workshop will include 

presentations and session discussions 

by experts in the fields of clinical 

pharmacology, obstetrics and 

gynecology, endocrinology, and clinical 

care. Each session will include a Q&A 

session to respond to questions from 

attendees. 

III. Participating in the Public 

Workshop 

Registration: To register for the public 

workshop, please visit the following 

website: https://www.fda.gov/ 

consumers/public-meetings-workshopsand-webinars/menopause-potentialimpact-clinical-pharmacology-andopportunities-future-research-10112023. 

Please provide complete contact 

information for each attendee, including 

name, title, affiliation, address, email, 

and telephone. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Registrants will receive 

confirmation when they have been 

accepted. If you need special 

accommodations due to a disability, 

please contact Lisa Lineberger at 

OWHmeetings@fda.hhs.gov no later 

than October 10, 2023. 

Dated: September 18, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20454 Filed 9–20–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–0908] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Submission of 

Petitions: Food Additive, Color 

Additive (Including Labeling), 

Submission of Information to a Master 

File in Support of Petitions; and 

Electronic Submission Using Food and 

Drug Administration Form 3503 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) 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. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by October 23, 

2023. 

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 0910–0016. 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. 

Submission of Petitions: Food 

Additive, Color Additive (Including 

Labeling), Submission of Information to 

a Master File in Support of Petitions; 

and Electronic Submission Using Form 

FDA 3503–21 CFR 70.25, 71.1, and 

171.1 and 21 CFR parts 172, 173, 179, 

and 180 OMB Control Number 0910– 

0016—Extension. 

Section 409(a) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 348(a)) provides that a food 

additive shall be deemed to be unsafe, 

unless: (1) the additive and its use, or 

intended use, are in conformity with a 

regulation issued under section 409 that 

describes the condition(s) under which 

the additive may be safely used; (2) the 

additive and its use, or intended use, 

conform to the terms of an exemption 

for investigational use; or (3) a food 

contact notification submitted under 

section 409(h) is effective. Food 

Additive Petitions (FAPs) are submitted 

by individuals or companies to obtain 

approval of a new food additive or to 

amend the conditions of use permitted 

under an existing food additive 

regulation. Section 171.1 of FDA’s 

regulations (21 CFR 171.1) specifies the 

information that a petitioner must 

submit in order to establish that the 

proposed use of a food additive is safe 

and to secure the publication of a food 

additive regulation describing the 

conditions under which the additive 

may be safely used. Parts 172, 173, 179, 

and 180 (21 CFR parts 172, 173, 179, 

and 180) contain labeling requirements 

for certain food additives to ensure their 

safe use. 

Section 721(a) of the FD&C Act (21 

U.S.C. 379e(a)) provides that a color 

additive shall be deemed to be unsafe 

unless the additive and its use are in 

conformity with a regulation that 

describes the condition(s) under which 

the additive may safely be used, or the 

additive and its use conform to the 

terms of an exemption for 

investigational use issued under section 

721(f). Color Additive Petitions (CAPs) 

are submitted by individuals or 

companies to obtain approval of a new 

color additive or a change in the 

conditions of use permitted for a color 

additive that is already approved. 

Section 71.1 of the Agency’s regulations 

(21 CFR 71.1) specifies the information 

that a petitioner must submit to 

establish the safety of a color additive 

and to secure the issuance of a 

regulation permitting its use. FDA’s 

color additive labeling requirements in 

§ 70.25 (21 CFR 70.25) require that color 

additives that are to be used in food, 

drugs, cosmetics, or medical devices be 

labeled with sufficient information to 

ensure their safe use. 

FDA scientific personnel review FAPs 

to ensure the safety of the intended use 

of the additive in or on food, or that may 

be present in food as a result of its use 

in articles that contact food. Likewise, 

FDA personnel review CAPs to ensure 

the safety of the color additive prior to 

its use in food, drugs, cosmetics, or 

medical devices. 


ddrumheller on DSK120RN23PROD with NOTICES1