Federal Register / Vol. 86, No. 151 / Tuesday, August 10, 2021 / Notices 43667 

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: 

Marieann Brill, Office of Pediatric 

Therapeutics, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5154, Silver Spring, 

MD 20993–0002, 240–402–3838, 

Marieann.Brill@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 coming to the meeting. 

SUPPLEMENTARY INFORMATION: Agenda: 

The meeting presentations will be 

heard, viewed, captioned, and recorded 

through an online teleconferencing 

platform. On September 17, 2021, the 

Pediatric Advisory Committee (PAC) 

will discuss pediatric-focused safety 

reviews, as mandated by the Best 

Pharmaceuticals for Children Act (Pub. 

L. 107–109) and the Pediatric Research 

Equity Act of 2003 (Pub. L. 108–155). 

The PAC will meet to discuss the 

following product: Center for Devices 

and Radiological Health FLOURISHTM

Pediatric Esophageal Atresia Device 

(humanitarian device exemption). 

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 at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s website after 

the meeting. Background material is 

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

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. All electronic and 

written submissions submitted to the 

Docket (see ADDRESSES) on or before 

September 10. 2021, will be provided to 

the committee. Oral presentations from 

the public will be scheduled between 

approximately 11:30 a.m. and 12:30 

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, and an 

indication of the approximate time 

requested to make their presentation on 

or before September 2, 2021. 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. The contact 

person will notify interested persons 

regarding their request to speak by 

September 2, 2021. 

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 Marieann Brill 

(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/ 

AdvisoryCommittees/ 

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. app. 2). 

Dated: August 4, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16984 Filed 8–9–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0834] 

Post-Marketing Pediatric-Focused 

Product Safety Reviews; 

Establishment of a Public Docket; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is establishing a 

public docket to collect comments 

related to the post-marketing pediatricfocused safety reviews of products 

posted between September 2, 2020, and 

September 2, 2021, on FDA’s website 

but not presented at the September 17, 

2021, Pediatric Advisory Committee 

(PAC) meeting. These reviews are 

intended to be available for review and 

comment by members of the PAC, 

interested parties (such as academic 

researchers, regulated industries, 

consortia, and patient groups), and the 

general public. 

DATES: Submit either electronic or 

written comments by September 24, 

2021. 

ADDRESSES: FDA is establishing a docket 

for public comment on this document. 

The docket number is FDA–2021–N– 

0834. The docket will close on 

September 24, 2021. Submit either 

electronic or written comments by that 


jbell on DSKJLSW7X2PROD with NOTICES
43668 Federal Register / Vol. 86, No. 151 / Tuesday, August 10, 2021 / Notices 

date. Please note that late, untimely 

comments will not be considered. 

Electronic comments must be submitted 

on or before September 24, 2021. The 

https://www.regulations.gov electronic 

filing system will accept comments 

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

of September 24, 2021. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

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– 

2021–N–0834 for ‘‘Post-Marketing 

Pediatric-Focused Product Safety 

Reviews; Establishment of a Public 

Docket; Request for Comments.’’ 

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, September18, 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: 

Marieann Brill, Office of the 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5154, Silver Spring, 

MD 20993, 240–402–3838, 

marieann.brill@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

responsible for protecting the public 

health by assuring the safety, efficacy, 

and security of human and veterinary 

drugs, biological products, medical 

devices, our Nation’s food supply, 

cosmetics, and products that emit 

radiation. FDA also has responsibility 

for regulating the manufacturing, 

marketing, and distribution of tobacco 

products to protect the public health 

and to reduce tobacco use by minors. 

FDA is establishing a public docket, 

Docket No. FDA–2021–N–0834, to 

receive input on post-marketing 

pediatric-focused safety reviews of 

products posted between September 2, 

2020, and September 2, 2021, available 

on FDA’s website at https://

www.fda.gov/AdvisoryCommittees/ 

CommitteesMeetingMaterials/ 

PediatricAdvisoryCommittee/ 

ucm510701.htm but not presented at the 

September 17, 2021, PAC meeting. FDA 

welcomes comments by members of the 

PAC, as mandated by the Best 

Pharmaceuticals for Children Act (Pub. 

L. 107–109) and the Pediatric Research 

Equity Act of 2003 (Pub. L. 108–155), 

interested parties (such as academic 

researchers, regulated industries, 

consortia, and patient groups), and the 

general public. The docket number is 

FDA–2021–N–0834. The docket will 

open on September 3, 2021, and remain 

open until September 24, 2021. The 

post-marketing pediatric-focused safety 

reviews are for the following products 

from the following centers at FDA: 

Center for Biologics Evaluation and 

Research 

1. CUVITRU (immune globulin 

subcutaneous (human), 20 percent 

solution) 

2. EPICEL (cultured epidermal 

autografts) 

3. JIVI (antihemophilic factor 

(recombinant), PEGylated-aucl) 

4. T.R.U.E. TEST (thin-layer rapid use 

epicutaneous patch test) 

5. REBINYN (nonacog beta pegol (N9– 

GP)) 

6. RUBBER PANEL T.R.U.E. TEST 

(Rubber Panel thin-layer rapid use 

epicutaneous patch test) 

7. ROTATEQ (Rotavirus vaccine, live, 

oral, pentavalent) 

Center for Drug Evaluation and 

Research 

1. APTIOM (eslicarbazepine acetate) 

2. CIALIS (tadalafil) 

3. COTEMPLA XR–ODT 

(methylphenidate extended release 

orally disintegrating tablets) 

4. EMEND (fosaprepitant dimeglumine) 

5. ENBREL (etanercept), ERELZI 

(etanercept-szzs), ETICOVO 

(etanercept-ykro) 

6. FASENRA (benralizumab) 

7. INTELENCE (etravirine) 

8. PEGASYS (peginterferon alfa-2a) 


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Federal Register / Vol. 86, No. 151 / Tuesday, August 10, 2021 / Notices 43669 

9. TEKTURNA (aliskiren hemifumarate) 

10. VIMOVO (naproxen/esomeprazole 

magnesium) 

11. VIREAD (tenofovir disoproxil 

fumarate) 

12. XOFLUZA (baloxavir marboxil) 

Center for Devices and Radiological 

Health 

1. CONTEGRA PULMONARY VALVED 

CONDUIT (Humanitarian Device 

Exemption (HDE)) 

2. ELANA SURGICAL KIT (HDE) 

3. ENTERRA THERAPY SYSTEM (HDE) 

4. LIPOSORBER LA–15 SYSTEM (HDE) 

5. MEDTRONIC ACTIVA DYSTONIA 

THERAPY (HDE) 

6. MINIMALLY INVASIVE DEFORMITY 

CORRECTION (MID–C) SYSTEM 

7. PLEXIMMUNE IN–VITRO 

DIAGNOSTIC TEST (HDE) 

8. PULSERIDER ANEURYSM NECK 

RECONSTRUCTION DEVICE (HDE) 

9. THE TETHER—VERTEBRAL BODY 

TETHERING SYSTEM 

Dated: August 5, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–17041 Filed 8–9–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, National 

Institutes of Health; Notice of Meeting 

Notice is hereby given of a meeting of 

the HEAL (Helping to End Addiction 

Long-Term) Multi-Disciplinary Working 

Group. 

The meeting will be open to the 

public as indicated below via NIH 

Videocast. Individuals who need special 

assistance, such as sign language 

interpretation or other reasonable 

accommodations, should notify the 

Contact Person listed below in advance 

of the meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The program documents 

and the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the program 

documents, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: HEAL MultiDisciplinary Working Group (MDWG) 

Meeting. 

Date: September 1–2, 2021. 

Open: September 01, 2021, 10:30 a.m. to 

11:30 a.m. 

Closed: September 02, 2021, 11:30 a.m. to 

4:30 p.m. 

Closed: September 02, 2021, 10:30 a.m. to 

3:45 p.m. 

Agenda: Provide an update on Helping to 

End Addiction Long-Term (HEAL) Initiative 

projects and obtain expertise from MDWG 

relevant to the NIH HEAL Initiative and to 

specific HEAL projects. 

Videocast: The open portion of the meeting 

will be live webcast at: https://

videocast.nih.gov/. 

Place: National Institutes of Health, 

Building 1, Wilson Hall, 1 Center Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Rebecca G Baker, Ph.D., 

Office of the Director, National Institutes of 

Health, 1 Center Drive, Room 103A, 

Bethesda, MD 20892, (301) 402–1994, 

Rebecca.baker@nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the Office 

of the Director for the NIH HEAL Initiative 

website: https://heal.nih.gov/news where an 

agenda and any additional information for 

the meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.853, Clinical Research 

Related to Neurological Disorders; 93.854, 

Biological Basis Research in the 

Neurosciences, National Institutes of Health, 

HHS) 

Dated: August 5, 2021. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–17012 Filed 8–9–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the Center for Scientific 

Review Advisory Council. 

The meeting will be open to the 

public, with attendance limited to space 

available. Individuals who plan to 

attend and need special assistance, such 

as sign language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

URL for virtual access:—https://

videocast.nih.gov/watch=42556 

Name of Committee: Center for Scientific 

Review Advisory Council. 

Date: September 27, 2021. 

Time: 1:00 p.m. to 4:30 p.m. 

Agenda: Provide advice to the Director, 

Center for Scientific Review (CSR), on 

matters related to planning, execution, 

conduct, support, review, evaluation, and 

receipt and referral of grant applications at 

CSR. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892, (Virtual Meeting). 

Contact Person: Bruce Reed, Ph.D., Deputy 

Director, Center for Scientific Review, 

National Institutes of Health, 6701 Rockledge 

Drive, Bethesda, MD 20892, (301) 594–9159, 

reedbr@mail.nih.gov. 

Information is also available on the 

Institute’s/Center’s home page: https://

public.csr.nih.gov/AboutCSR/Organization/ 

CSRAdvisoryCouncil, where an agenda and 

any additional information for the meeting 

will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: August 5, 2021. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–17043 Filed 8–9–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Notice of Listing of Members of the 

National Institutes of Health’s Senior 

Executive Service 2021 Performance 

Review Board (PRB) 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The National Institutes of 

Health (NIH) announces the persons 

who will serve on the National 

Institutes of Health’s Senior Executive 

Service 2021 Performance Review 

Board. 

FOR FURTHER INFORMATION CONTACT: For 

further information about the NIH 

Performance Review Board, contact Mr. 

Kha Nguyen, Director, Division of 

Senior and Scientific Executive 

Management, Office of Human 

Resources, National Institutes of Health, 

Building 31, Room 1C31P, Bethesda, 

Maryland 20892, telephone 

301.594.3022 (not a toll-free number), 

email kha.nguyen@nih.gov. 

SUPPLEMENTARY INFORMATION: This 

action is being taken in accordance with 


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