76478 Federal Register / Vol. 89, No. 181 / Wednesday, September 18, 2024 / Notices 

2024 NSECE LONGITUDINAL FOLLOW-UPS (NEW REQUEST UNDER THIS OMB NUMBER) 

Instrument 

Number of 

respondents 

(total over 

request 

period) 

Number of 

responses per 

respondent 

(total over 

request 

period) 

Average 

burden 

per response 

(in hours) 

Total/annual 

burden 

(in hours) 

2024 NSECE Household Follow-up Questionnaire ......................................... 3,750 1 .36 1,350 

2024 NSECE Workforce Follow-up Questionnaire (Classroom Staff) ............ 5,550 1 .33 1,832 

2024 NSECE Household Longitudinal Follow-up Quality Assurance Questionnaire ........................................................................................................ 38 1 .05 1.9 

2024 NSECE Workforce Longitudinal Follow-up Quality Assurance Questionnaire ........................................................................................................ 56 1 .05 2.8 

Estimated Total Annual Burden 

Hours: 3,187. 

CURRENTLY APPROVED AND ONGOING UNDER THIS OMB NUMBER

Instrument 

Number of 

respondents 

(total over 

request 

period) 

Number of 

responses per 

respondent 

(total over 

request 

period) 

Average 

burden 

per response 

(in hours) 

Total/annual 

burden 

(in hours) 

2024 NSECE Household Screener ................................................................. 17,187 1 .1 1,719 

2024 NSECE Household Questionnaire ......................................................... 4,231 1 1 4,231 

2024 NSECE Home-based Provider Screener (listed home-based providers) ........................................................................................................... 264 1 .03 8 

2024 NSECE Home-based Provider Screener and Questionnaire (listed 

home-based providers) ................................................................................ 946 1 .67 634 

2024 NSECE Home-based Provider Screener and Questionnaire (unlisted 

home-based providers) ................................................................................ 175 1 .33 58 

2024 NSECE Center-based Provider Screener .............................................. 4,401 1 .1 440 

2024 NSECE Center-based Provider Screener and Questionnaire ............... 3,602 1 .75 2,702 

2024 NSECE Workforce (Classroom Staff) Questionnaire ............................. 3,794 1 .33 1,252 

Estimated Total Annual Burden 

Hours: 11,044. 

Authority: Child Care and 

Development Block Grant Act of 1990, 

as amended by the CCDBG Act of 2014 

(Pub. L. 113–186). Social Security Act, 

section 418 as extended by the 

Continuing Appropriations Act of 2017 

and the TANF Extension Act of 2019. 

Section 3507 of the Paperwork 

Reduction Act of 1995, 44 U.S.C. 

chapter 35. 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–21210 Filed 9–17–24; 8:45 am] 

BILLING CODE 4184–23–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4188] 

Pharmacy Compounding Advisory 

Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments—Bulk Drug 

Substances Nominated for Inclusion 

on the Section 503A Bulk Drug 

Substances List; Revisions to the 

Withdrawn or Removed List 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Pharmacy Compounding 

Advisory Committee (the Committee). 

The general function of the Committee 

is to provide advice and 

recommendations to FDA on regulatory 

issues. The meeting will be open to the 

public. FDA is establishing a docket for 

public comment on this document. 

DATES: The meeting will be held on 

October 29, 2024, from 8 a.m. to 5 p.m. 

eastern time. 

ADDRESSES: The meeting will be held at 

the FDA White Oak Campus, 10903 

New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

The public will also have the option to 

participate via an online 

teleconferencing and/or video 

conferencing platform, and the advisory 

committee meeting will be heard, 

viewed, captioned, and recorded 

through an online teleconferencing and/ 

or video conferencing platform. 

Answers to commonly asked 

questions about FDA advisory 

committee meetings, including 

information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: https://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2024–N–4188. 


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Federal Register / Vol. 89, No. 181 / Wednesday, September 18, 2024 / Notices 76479 

The docket will close on October 28, 

2024. 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 

on October 28, 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. 

Comments received on or before 

October 15, 2024, will be provided to 

the Committee. Comments received after 

that date will be taken into 

consideration by FDA. In the event that 

the meeting is canceled, FDA will 

continue to evaluate any relevant 

information, and consider any 

comments submitted to the docket, as 

appropriate. 

You may submit comments as 

follows: 

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–4188 for ‘‘Pharmacy 

Compounding Advisory Committee; 

Notice of Meeting; Establishment of a 

Public Docket; Request for Comments— 

Bulk Drug Substances Nominated for 

Inclusion on the Section 503A Bulk 

Drug Substances List; Revisions to the 

Withdrawn or Removed List.’’ 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.’’ FDA 

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 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 the 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: 

Takyiah Stevenson, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 240– 

402–2507, email: PCAC@fda.hhs.gov, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area). A notice in 

the Federal Register about last-minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check 

FDA’s website at https://www.fda.gov/ 

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before the meeting. 

SUPPLEMENTARY INFORMATION: 

Background: Section 503A of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 353a) describes 

the conditions that must be satisfied for 

human drug products compounded by a 

licensed pharmacist in a State licensed 

pharmacy or a Federal facility, or a 

licensed physician, to be exempt from 

the following three sections of the FD&C 

Act: (1) section 501(a)(2)(B) (21 U.S.C. 

351(a)(2)(B)) (concerning current good 

manufacturing practice requirements); 

(2) section 502(f)(1) (21 U.S.C. 352(f)(1)) 

(concerning the labeling of drugs with 

adequate directions for use); and (3) 

section 505 (21 U.S.C. 355) (concerning 

the approval of human drug products 

under new drug applications (NDAs) or 

abbreviated new drug applications 

(ANDAs)). 

Section 503B of the FD&C Act 

describes the conditions that must be 

satisfied for drug products compounded 

in an outsourcing facility to be exempt 

from: (1) section 502(f)(1), (2) section 

505, and (3) section 582 (21 U.S.C. 

360eee-1) (concerning drug supply 

chain security requirements) of the 

FD&C Act. 

One of the conditions that must be 

satisfied for a drug product to qualify for 

the exemptions under section 503A of 

the FD&C Act is that the licensed 

pharmacist or licensed physician 

compounds the drug product using bulk 

drug substances (as defined in 21 CFR 

207.3) that: (1) comply with the 

standards of an applicable United States 

Pharmacopoeia (USP) or National 

Formulary monograph, if a monograph 

exists, and the USP chapter on 

pharmacy compounding; (2) if an 

applicable monograph does not exist, 

are drug substances that are components 


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76480 Federal Register / Vol. 89, No. 181 / Wednesday, September 18, 2024 / Notices 

of drugs approved by the Secretary of 

Health and Human Services (the 

Secretary); or (3) if such a monograph 

does not exist and the drug substance is 

not a component of a drug approved by 

the Secretary, that appear on a list 

developed by the Secretary through 

regulations issued by the Secretary 

under section 503A(c) of the FD&C Act 

(the 503A Bulks List) (see section 

503A(b)(1)(A)(i) of the FD&C Act). 

One of the conditions that must be 

satisfied for the compounded drug to 

qualify for the exemptions under section 

503A or section 503B of the FD&C Act 

is that the drug that is compounded 

does not appear on a list published by 

the Secretary of drugs that have been 

withdrawn or removed from the market 

because such drug products or 

components of such drug products have 

been found to be unsafe or not effective 

(Withdrawn or Removed List) (see 

sections 503A(b)(1)(C) and 503B(a)(4) of 

the FD&C Act). The Withdrawn or 

Removed List is codified at § 216.24 (21 

CFR 216.24). 

Agenda: FDA, invited attendees, and 

the public will be able to attend the 

meeting in-person at FDA’s White Oak 

Campus (see ADDRESSES). The meeting 

presentations will also be heard, 

viewed, captioned, and recorded 

through an online teleconferencing and/ 

or video conferencing platform. The 

Committee will discuss the following 

bulk drug substances being considered 

for inclusion on the 503A Bulks List: 

ibutamoren mesylate, L-theanine, 

ipamorelin-related bulk drug substances 

(ipamorelin acetate and ipamorelin (free 

base)), and kisspeptin-10. The chart 

below identifies the use(s) FDA 

reviewed for each of the bulk drug 

substances being discussed at this 

advisory committee meeting. For 

nominated bulk drug substances, the 

nominators of these substances will be 

invited to make a short presentation 

supporting the nomination. 

Bulk drug 

substance Uses evaluated 

Ibutamoren 

mesylate.

Treatment of growth hormone deficiency (GHD), 

osteoporosis, hip fracture, 

sarcopenia, obesity, and 

Alzheimer’s disease. 

L-theanine ...... Sleep disorders and anxiety 

disorders. 

Ipamorelin acetate.

Ipamorelin 

(free base).

GHD and postoperative 

ileus. 

Kisspeptin-10 Treatment of secondary 

hypogonadism in men. 

The Committee will also discuss a 

revision FDA is considering to the 

Withdrawn or Removed List. 

Specifically, FDA is considering 

whether to amend § 216.24 to add an 

entry to the list: hydroxyprogesterone 

caproate: all drug products containing 

hydroxyprogesterone caproate to reduce 

the risk of preterm birth in women with 

a singleton pregnancy who have a 

history of singleton spontaneous birth. 

As previously explained in the Federal 

Register of July 2, 2014 (79 FR 37687 at 

37689 through 37690), the list entry may 

specify that a drug may not be 

compounded in any form. Alternatively, 

the list entry may expressly exclude a 

particular formulation, indication, 

dosage form, or route of administration 

from an entry on the list, or a drug may 

be listed only with regard to certain 

formulations, indications, routes of 

administration, or dosage forms. FDA 

plans to seek the Committee’s advice 

concerning the inclusion of this entry 

on the list. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting. Background 

material and the link to the online 

teleconference and/or video conference 

meeting will be available at the location 

of the advisory committee meeting and 

at https://www.fda.gov/Advisory

Committees/Calendar/default.htm. 

Scroll down to the appropriate advisory 

committee meeting link. The meeting 

will include slide presentations with 

audio and video components to allow 

the presentation of materials for online 

participants in a manner that most 

closely resembles an in-person advisory 

committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the Committee. All electronic and 

written submissions to the Docket (see 

ADDRESSES) on or before October 15, 

2024, will be provided to the 

Committee. Oral presentations from the 

public will be scheduled following FDA 

presentations. FDA has allotted 

approximately 1 hour for open public 

hearing presentations, which will be 

split to allow for public remarks on each 

substance. The sessions will begin at 

approximately 9:10 a.m., 11 a.m., 1:50 

p.m., 3:15 p.m., and 4:30 p.m. Those 

individuals interested in making formal 

oral presentations should notify the 

contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, whether they 

would like to present online or inperson, and an indication of the 

approximate amount of time requested 

to make their presentation on or before 

October 4, 2024. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. FDA may also extent 

the time scheduled for open public 

hearing presentations depending on 

interest. Similarly, room for interested 

persons to participate in-person may be 

limited. If the number of registrants 

requesting to speak in-person during the 

open public hearing is greater than can 

be reasonably accommodated in the 

venue for the in-person portion of the 

advisory committee meeting, FDA may 

conduct a lottery to determine the 

speakers who will be invited to 

participate in-person. The contact 

person will notify interested persons 

regarding their request to speak and the 

timeframe for the presentation by 

October 7, 2024. Persons attending 

FDA’s advisory committee meetings are 

advised that FDA is not responsible for 

providing access to electrical outlets. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Takyiah 

Stevenson (see FOR FURTHER

INFORMATION CONTACT) at least 7 days in 

advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.). This meeting notice 

also serves as notice that, pursuant to 21 

CFR 10.19, the requirements in 21 CFR 

14.22(b), (f), and (g) relating to the 

location of advisory committee meetings 

are hereby waived to allow for this 

meeting to take place using an online 

meeting platform in conjunction with 

the physical meeting room (see 

location). This waiver is in the interest 

of allowing greater transparency and 

opportunities for public participation, 

in addition to convenience for advisory 


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Federal Register / Vol. 89, No. 181 / Wednesday, September 18, 2024 / Notices 76481 

committee members, speakers, and 

guest speakers. The conditions for 

issuance of a waiver under 21 CFR 10.19 

are met. 

Dated: September 12, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21241 Filed 9–17–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–2870] 

Conducting Clinical Trials With 

Decentralized Elements; Guidance for 

Industry, Investigators, and Other 

Interested Parties Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry, investigators, and 

other interested parties entitled 

‘‘Conducting Clinical Trials With 

Decentralized Elements.’’ This guidance 

provides recommendations regarding 

the implementation of decentralized 

elements in clinical trials for drugs, 

biological products, and devices. 

Decentralized elements allow trialrelated activities to occur remotely at 

locations convenient for trial 

participants (e.g., telehealth visits with 

investigators or visits with local 

healthcare providers (HCPs)). FDA’s 

regulatory requirements are the same for 

trials that include decentralized 

elements and trials that do not include 

decentralized elements. To help ensure 

the appropriate oversight trials with 

decentralized elements, the integrity of 

trial data, and the safety of trial 

participants, this guidance covers the 

responsibilities of sponsors and 

investigators. This guidance finalizes 

the draft guidance entitled 

‘‘Decentralized Clinical Trials for Drugs, 

Biological Products, and Devices’’ 

issued on May 3, 2023. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on September 18, 2024. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

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– 

2022–D–2870 for ‘‘Conducting Clinical 

Trials With Decentralized Elements.’’ 

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.’’ 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 this 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; 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; or 

the Office of Policy, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Ryan Robinson, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 3342, 

Silver Spring, MD 20993, 240–402– 

9756; James Myers, Center for Biologics 

Evaluation and Research, Food and 


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