Federal Register / Vol. 87, No. 88 / Friday, May 6, 2022 / Notices 27163 

1ANDA 080911 for TESTOPEL is currently held 

by Endo Pharmaceuticals, Inc. 

I. Background 

In the Federal Register of June 11, 

2010 (75 FR 33311), FDA announced the 

availability of a guidance for industry 

entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products,’’ which explained the process 

that would be used to make productspecific guidances available to the 

public on FDA’s website at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs. 

As described in that guidance, FDA 

adopted this process to develop and 

disseminate product-specific guidances 

and to provide a meaningful 

opportunity for the public to consider 

and comment on the guidances. This 

notice announces the availability of a 

revised draft guidance on a generic 

testosterone pellet. 

FDA initially approved ANDA 080911 

for TESTOPEL (testosterone pellet) in 

July 1972. FDA issued a draft guidance 

for industry on generic testosterone 

pellet in August 2011. We are now 

issuing a revised draft guidance for 

industry on generic testosterone pellet 

(‘‘Draft Guidance for Testosterone’’). 

In July 2012, Actient Pharmaceuticals, 

manufacturer, at that time, of 

TESTOPEL, ANDA 080911,1 submitted 

a citizen petition requesting, among 

other things, that FDA refrain from 

approving any ANDA referencing 

TESTOPEL unless certain conditions are 

satisfied, including conditions related to 

demonstrating BE (Docket No. FDA– 

2012–P–0737, available at https://

www.regulations.gov). FDA is reviewing 

the issues raised in the petition and will 

consider any comments on the draft 

guidance entitled ‘‘Draft Guidance for 

Testosterone’’ before responding to the 

citizen petition. 

This revised draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The revised draft guidance, 

when finalized, will represent the 

current thinking of FDA on the 

information and data to demonstrate BE 

to support ANDAs for testosterone 

pellet. It does not establish any rights 

for any person and is not binding on 

FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

draft guidance contains no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: May 2, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09737 Filed 5–5–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0357] 

Pharmacy Compounding Advisory 

Committee; Notice of Meeting; 

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) announces a 

forthcoming public advisory committee 

meeting of the Pharmacy Compounding 

Advisory 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 June 

8, 2022, from 9:30 a.m. to 5:15 p.m. 

Eastern Time. 

ADDRESSES: Please note that due to the 

impact of this COVID–19 pandemic, all 

meeting participants will be joining this 

advisory committee meeting via an 

online teleconferencing platform. 

Answers to commonly asked questions 

about FDA advisory committee meetings 

may be accessed at: https://

www.fda.gov/AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2021–N–0357. 

The docket will close on June 7, 2022. 

Submit either electronic or written 

comments on this public meeting by 

June 7, 2022. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before June 7, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of June 7, 2022. 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. 

Comments received on or before May 

24, 2022, 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 cancelled, FDA will 

continue to evaluate any relevant 

applications or 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 


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27164 Federal Register / Vol. 87, No. 88 / Friday, May 6, 2022 / Notices 

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–0357 for ‘‘Pharmacy 

Compounding Advisory Committee; 

Notice of Meeting; 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, 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, Fax: 301–847–8533, 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 the 

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: 

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); (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 

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 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 21 CFR 216.24. 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. The 

committee will discuss the following 

four bulk drug substances nominated for 

inclusion on the 503A Bulks List: 

Ammonium tetrathiomolybdate, 

enclomiphene citrate, ferric subsulfate, 

and glutathione. The chart below 

identifies the use(s) FDA reviewed for 

each of the four bulk drug substances 

being discussed at this advisory 

committee meeting. The nominators of 

these substances or another interested 

party will be invited to make a short 

presentation supporting the nomination. 

Bulk drug substance Uses evaluated 

Ammonium Tetrathiomolybdate .. Wilson disease, use as copper (Cu) chelation therapy for the treatment of breast cancer, kidney cancer, 

prostate cancer, colorectal cancer, esophageal cancer, and malignant pleural mesothelioma. 

Enclomiphene Citrate .................. To increase serum testosterone, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) to normal 

levels in the treatment of secondary hypogonadism. 

Ferric Subsulfate ......................... For use as an astringent and hemostatic agent during minor surgical procedures. 


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Federal Register / Vol. 87, No. 88 / Friday, May 6, 2022 / Notices 27165 

Bulk drug substance Uses evaluated 

Glutathione .................................. Skin lightening, cystic fibrosis, asthma, chronic obstructive pulmonary disease, chronic lung disease, 

oxidative stress, reduction of the side effects of chemotherapy, inhibition of chemical induced carcinogenesis, prevention of radiation injury, treatment of heavy metal poisoning (cadmium and mercury), acetaminophen toxicity, autism spectrum disorder, Alzheimer’s disease, Parkinson’s disease, major depressive 

disorder, schizophrenia, helicobacter pylori infection, human immunodeficiency virus infection, tuberculosis, 

otitis media, peripheral obstructive arterial disease, anemia, diabetes, and septic shock. 

The committee will also discuss 

revisions FDA is considering to the 

Withdrawn or Removed List. FDA now 

is considering whether to amend the 

rule to add one more entry to the list: 

Lorcaserin Hydrochloride: All drug 

products containing lorcaserin 

hydrochloride. As previously explained 

in the Federal Register of July 2, 2014 

(79 FR 37687 at 37689 through 37690), 

the list may specify that a drug may not 

be compounded in any form, or, 

alternatively, may expressly exclude a 

particular formulation, indication, 

dosage form, or route of administration 

from an entry on the list. Moreover, a 

drug may be listed only with regard to 

certain formulations, indications, routes 

of administration, or dosage forms 

because it has been found to be unsafe 

or not effective in those particular 

formulations, indications, routes of 

administration, or dosage forms. FDA 

plans to seek the committee’s advice 

concerning the inclusion of this drug 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 meeting room will be 

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

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. The meeting will include slide 

presentations with audio components to 

allow the presentation of materials 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 submitted to the 

Docket (see ADDRESSES) on or before 

May 24, 2022, will be provided to the 

committee. Oral presentations from the 

public will be scheduled between 

approximately 10:35 a.m. to 10:50 a.m., 

12:15 p.m. to 12:30 p.m., 2:25 p.m. to 

2:40 p.m., 3:45 p.m. to 4 p.m., and 4:50 

p.m. to 5:05 p.m. Eastern Time. 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 May 16, 2022. 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 May 17, 2022. 

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/ 

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: May 3, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09797 Filed 5–5–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0109] 

Fostering Medical Device 

Improvement: Food and Drug 

Administration Activities and 

Engagement With the Voluntary 

Improvement Program; Draft Guidance 

for Industry and Food and Drug 

Administration Staff; Availability; 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of the draft 

guidance entitled ‘‘Fostering Medical 

Device Improvement: FDA Activities 

and Engagement with the Voluntary 

Improvement Program.’’ FDA is issuing 

this draft guidance to describe its policy 

regarding FDA’s participation in the 

Voluntary Improvement Program (VIP). 

The VIP is a voluntary program 

facilitated through the Medical Device 

Innovation Consortium (MDIC) that 

evaluates the capability and 

performance of a medical device 

manufacturer’s practices using thirdparty appraisals, and is intended to 

guide improvement to enhance the 

quality of devices. The VIP builds on 

the framework piloted through FDA’s 

2018 Case for Quality Voluntary 

Medical Device Manufacturing and 

Product Quality Pilot Program (CfQ 

Pilot Program) and incorporates some of 

the successes and learnings from the 

pilot. This draft guidance is not final 

nor is it in effect at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by July 5, 2022 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

Submit electronic or written comments 

on the proposed collection of 

information in the draft guidance by 

July 5, 2022. 


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