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Withdrawn or Removed List.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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27166 Federal Register / Vol. 87, No. 88 / Friday, May 6, 2022 / Notices 

ADDRESSES: You may submit comments 

on any guidance 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–0109 for ‘‘Fostering Medical 

Device Improvement: FDA Activities 

and Engagement with the Voluntary 

Improvement Program.’’ 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)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Fostering Medical 

Device Improvement: FDA Activities 

and Engagement with the Voluntary 

Improvement Program’’ to the Office of 

Policy, Guidance and Policy 

Development, 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 request. 

FOR FURTHER INFORMATION CONTACT: 

With regard to the draft guidance: 

Francisco Vicenty, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1534, Silver Spring, 

MD 20993–0002, 301–796–5577. 

With regard to the proposed collection 

of information: 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: 

I. Background 

As part of Center for Devices and 

Radiological Health’s (CDRH) 2016– 

2017 strategic priority to ‘‘Promote a 

Culture of Quality and Organizational 

Excellence,’’ CDRH envisions a future 

where the medical device ecosystem is 

inherently focused on device features 

and manufacturing practices that have 

the greatest impact on product quality 

and patient safety. Among its other 

regulatory activities, FDA evaluates 

manufacturers’ compliance with 

regulations governing the design and 

production of devices. Compliance with 

21 CFR part 820, ‘‘Quality System 

Regulation,’’ is a baseline requirement 

for medical device manufacturing firms. 

In an effort to elevate and enhance 

manufacturing practices and behaviors 

through which quality and safety of 

medical devices can be improved, FDA 

has collaborated with various 

stakeholders, brought together through 

the MDIC public-private partnership, to 

develop the CfQ Pilot Program. FDA 

announced the voluntary CfQ Pilot 

Program in the Federal Register on 

December 28, 2017 (82 FR 61575). 

As in the CfQ Pilot Program, the VIP 

oversees third-party appraisers who 

evaluate voluntary industry 

participants, and the VIP assesses the 

capability and performance of key 

business processes using a series of 

integrated best practices. Those 

practices are detailed in the Information 

Systems Audit and Control Association 

Capability Maturity Model Integration 

(CMMI) system. CMMI provides a 

roadmap that guides improvement 

towards disciplined and consistent 

processes for achieving key business 

objectives, including quality and 

performance. VIP uses a version of the 

CMMI appraisal appropriate for the 

medical device industry. This appraisal 

tool is referred to as the Medical Device 

Discovery Appraisal Program (MDDAP) 

model. The baseline appraisal using the 

MDDAP model covers 11 practices 

areas, including Estimating, Planning, 

and Configuration Management. As part 

of the VIP, and as in the CfQ Pilot 

Program, the VIP provides firms and 

FDA with information about the firm’s 

capability and performance for activities 

covered in the third-party appraisal. 


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Federal Register / Vol. 87, No. 88 / Friday, May 6, 2022 / Notices 27167 

Details and results from the 2018 CfQ 

Pilot Program are outlined in MDIC’s 

Case for Quality Pilot Report, available 

at https://www.fda.gov/medical-devices/ 

quality-and-compliance-medicaldevices/case-quality-pilot-activities. 

This voluntary program is currently 

only available to eligible manufacturers 

of medical devices regulated by CDRH 

and whose marketing applications are 

reviewed under the applicable 

provisions of the Federal Food, Drug, 

and Cosmetic Act (including under 

sections 510(k), 513, 515, and 520). The 

voluntary CfQ Pilot Program was 

implemented for devices regulated by 

CDRH, and products regulated by the 

Center for Biologics Evaluation and 

Research (CBER) were not part of the 

CfQ Pilot Program. CBER is interested in 

hearing from manufacturers of device 

products regulated by CBER under 

sections 510(k), 513, 515, and 520 (21 

U.S.C. 360(k), 360c, 360e, and 360j) 

about their interest in participating in 

such a program. CBER requests 

comments from stakeholders regarding 

the possible application of this program 

to CBER-regulated devices. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Fostering Medical Device 

Improvement: FDA Activities and 

Engagement with the Voluntary 

Improvement Program.’’ 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. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

CDRH guidance documents is available 

at https://www.fda.gov/medical-devices/ 

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This 

guidance document is also available at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments and https://

www.regulations.gov. Persons unable to 

download an electronic copy of 

‘‘Fostering Medical Device 

Improvement: FDA Activities and 

Engagement with the Voluntary 

Improvement Program’’ may send an 

email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number 20039 and complete 

title to identify the guidance you are 

requesting. 

III. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

of 1995 (PRA) (44 U.S.C. 3501–3521), 

Federal Agencies must obtain approval 

from the Office of Management and 

Budget (OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Medical Devices; Voluntary 

Improvement Program 

OMB Control Number 0910–NEW 

The VIP is a voluntary program 

facilitated through the MDIC publicprivate partnership that evaluates the 

capability and performance of a medical 

device manufacturer’s practices using 

third-party appraisals and is intended to 

guide improvement to enhance the 

quality of devices. FDA is issuing the 

draft guidance entitled ‘‘Fostering 

Medical Device Improvement: FDA 

Activities and Engagement with the 

Voluntary Improvement Program’’ to 

describe its policy regarding FDA’s 

participation in the VIP. As part of the 

VIP process, FDA receives information 

about participating device 

manufacturers’ capability and 

performance for activities covered in 

third-party appraisals. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses Average burden per response Total hours 

Site manufacturer application ........... 1 400 400 0.08 (5 minutes) ............................... 33 

Aggregate data reporting .................. 1 4 4 8 ....................................................... 32 

Summary of site appraisal ................ 1 400 400 20 ..................................................... 8,000 

Total ........................................... ........................ ........................ ........................ ........................................................... 8,065 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2 Numbers in table have been rounded. 

Based on device registration and 

listing data and informal feedback from 

stakeholders, we anticipate 

approximately 400 sites may participate 

in the VIP annually. 

The estimated Average Burdens per 

Response are largely based on our 

experience with the voluntary CfQ Pilot 

Program and were determined in 

consultation with our subject matter 

experts who are familiar with this 

program. 

Site Manufacturer Application 

Third-party appraisers forward 

participating site manufacturers’ 


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27168 Federal Register / Vol. 87, No. 88 / Friday, May 6, 2022 / Notices 

applications to FDA. FDA confirms 

whether certain information in the 

application is consistent with FDA’s 

existing records. This helps the thirdparty appraiser to determine the 

manufacturers’ eligibility for 

participation in the VIP. We expect each 

application will take approximately 5 

minutes to submit. 

Aggregate Data Reporting 

The third-party appraiser provides 

FDA with aggregated data across all 

participating manufacturer sites 

quarterly. The aggregate data is used to 

identify broad industry trends and 

patterns that FDA may consider in the 

benefit-risk considerations FDA 

routinely uses to inform planning, 

improve FDA resource allocations, 

improve review efficiency, and inform 

risk-based inspection planning. We 

expect that it will take approximately 8 

hours to prepare and submit the 

aggregate data. 

Summary of Site Appraisal 

The third-party appraiser provides 

FDA with a summary of the appraisal 

result for each participating site. FDA 

intends to consider this information in 

the benefit-risk considerations FDA 

routinely uses to inform planning, 

improve FDA resource allocations, 

improve review efficiency, and inform 

risk-based inspection planning for firms 

that demonstrate capability and 

transparency around their 

manufacturing and product 

performance. We expect it will take 

approximately 20 hours to complete 

each summary. 

The VIP and Certain Regulatory 

Submissions 

FDA expects to gain insights into a 

participant’s manufacturing processes 

and control capabilities intended to 

satisfy recommendations for certain 

PMA or HDE submissions (e.g., PMA/ 

HDE 30-Day Change Notices, PMA/HDE 

Manufacturing Site Change 

Supplements, PMA/HDE Manufacturing 

Modules). Thus, participants in the VIP 

may be able to avail themselves of 

efficiencies that would prevent 

duplicate information and/or allow for 

least burdensome submissions to FDA. 

FDA plans to improve stakeholder 

opportunities to use modified templates 

for such submissions. 

The draft guidance also refers to 

previously approved collections of 

information. These collections of 

information are subject to review by the 

OMB under the PRA. The collections of 

information in the following FDA 

regulations have been approved by OMB 

as listed in the following table: 

21 CFR part Topic OMB control No. 

814, subparts A through E ...................................................... Premarket approval ................................................................. 0910–0231 

814, subpart H ......................................................................... Humanitarian Device Exemption ............................................. 0910–0332 

820 ........................................................................................... Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation.0910–0073 

7 ............................................................................................... Recalls ..................................................................................... 0910–0432 

803 ........................................................................................... Medical Device Reporting ....................................................... 0910–0437 

807, subparts A through D ...................................................... Establishment Registration and Listing ................................... 0910–0625 

Dated: April 29, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09734 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–N–0576] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Investigational 

Device Exemptions 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection associated with 

investigational device exemptions. 

DATES: Submit either electronic or 

written comments on the collection of 

information by July 5, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before July 5, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of July 5, 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. 

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 


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