Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices 41475 

and non-biological parents such as 

adoptive, foster, or stepparents. 

The types of information collection 

activities included in this generic 

package are: 

(1) Quantitative data collection 

through electronic, telephone, or paper 

questionnaires to gather information 

about programmatic and service 

activities related to the prevention of 

HIV and other STDs among adolescents 

of middle- and high-school age. 

(2) Qualitative data collection through 

electronic, telephone, or paper means to 

gather information about programmatic 

and service activities related to the 

prevention of HIV and other STDs 

among adolescents of middle- and highschool age. Qualitative data collection 

may involve focus groups and in-depth 

interviewing through group interviews, 

and cognitive interviewing. 

For adolescents, data collection 

instruments will include questions on 

demographic characteristics; 

experiences with programs and services 

to reduce the risk of HIV and other STD 

transmission; and knowledge, attitudes, 

behaviors, and skills related to sexual 

risk and protective factors on the 

individual, interpersonal, and 

community levels. 

For parents and caregivers, data 

collection instruments will include 

questions on demographic 

characteristics as well as parents’/ 

caregivers’ (1) perceptions about 

programs and services provided to 

adolescents; (2) knowledge, attitudes, 

and perceptions about their adolescents’ 

health risk and protective behaviors; 

and (3) parenting knowledge, attitudes, 

behaviors, and skills. 

Any data collection request put 

forward under this generic clearance 

will identify the programs and/or 

services to be informed or refined, and 

will include a cross-walk of data 

elements to the aspects of the program 

the project team seeks to inform or 

refine. Because this request includes a 

wide range of possible data collection 

instruments, specific requests will 

include items of information to be 

collected and copies of data collection 

instruments. It is expected that all data 

collection instruments will be pilottested, and will be culturally, 

developmentally, and age appropriate 

for the adolescent populations included. 

Similarly, parent data collection 

instruments will be pilot-tested, and the 

data collection instruments will reflect 

the culture, developmental stage, and 

age of the parents’ adolescent children. 

All data collection procedures will 

receive review and approval by an 

Institutional Review Board for the 

Protection of Human Subjects and 

follow appropriate consent and assent 

procedures as outlined in the IRBapproved protocols. These will be 

described in the individual information 

collection requests put forward under 

this Generic package. 

The table below provides the 

estimated annualized response burden 

for up to 15 individual data collections 

per year under this generic clearance at 

57,584 hours. Participation of 

respondents is voluntary. There is no 

cost to participants other than their 

time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Middle and High School Age Adolescents.Youth Questionnaire ........................ 20,000 1 50/60 16,667 

Middle and High School Age Adolescents.Pre/Post youth questionnaire ........... 10,000 2 50/60 16,667 

Middle and High School Age Adolescents.Youth interview/focus group guide ... 3,000 2 90/60 9,000 

Parents/caregivers of adolescents .... Parent/Caregiver questionnaire ....... 7,500 2 25/60 6,250 

Parents/caregivers of adolescents .... Parent/Caregiver interview/focus 

group guide.

3,000 2 90/60 9,000 

Total ........................................... ........................................................... ........................ ........................ ........................ 57,584 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2021–16376 Filed 7–30–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0758] 

Antimicrobial Drugs Advisory 

Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments 

AGENCY: Food and Drug Administration, 

Health and Human Services (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 Antimicrobial Drugs 

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 

October 7, 2021, from 9 a.m. to 5 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–0758. 

The docket will close on October 6, 

2021. Submit either electronic or 

written comments on this public 

meeting by October 6, 2021. Please note 

that late, untimely filed comments will 

not be considered. Electronic comments 

must be submitted on or before October 

6, 2021. The https://

www.regulations.gov electronic filing 


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41476 Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices 

system will accept comments until 

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

October 6, 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. 

Comments received on or before 

September 23, 2021, 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 

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–0758 for ‘‘Antimicrobial Drugs 

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: 

Moon Hee V. Choi, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

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

Silver Spring, MD 20993–0002, 301– 

796–2894, Fax: 301–847–8533, email: 

AMDAC@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. The 

committee will discuss new drug 

application (NDA) 215596, for maribavir 

oral tablets, submitted by Takeda 

Pharmaceuticals USA, Inc., for the 

treatment of adults with post-transplant 

cytomegalovirus infection and/or 

disease, including infections resistant 

and/or refractory to ganciclovir, 

valganciclovir, cidofovir, or foscarnet. 

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 

September 23, 2021, will be provided to 

the committee. Oral presentations from 

the public will be scheduled between 

approximately 1 p.m. and 2 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 


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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices 41477 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before September 15, 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 16, 2021. 

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 Moon Hee V. 

Choi (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/AboutAdvisory

Committees/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: July 27, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16356 Filed 7–30–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0659] 

Medical Device User Fee Rates for 

Fiscal Year 2022 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

fee rates and payment procedures for 

medical device user fees for fiscal year 

(FY) 2022. The Federal Food, Drug, and 

Cosmetic Act (FD&C Act), as amended 

by the Medical Device User Fee 

Amendments of 2017 (MDUFA IV), 

authorizes FDA to collect user fees for 

certain medical device submissions and 

annual fees both for certain periodic 

reports and for establishments subject to 

registration. This notice establishes the 

fee rates for FY 2022, which apply from 

October 1, 2021, through September 30, 

2022, and provides information on how 

the fees for FY 2022 were determined, 

the payment procedures you should 

follow, and how you may qualify for 

reduced small business fees. 

FOR FURTHER INFORMATION CONTACT:

For information on Medical Device 

User Fees: https://www.fda.gov/ 

industry/fda-user-fee-programs/ 

medical-device-user-fee-amendmentsmdufa. 

For questions relating to the MDUFA 

Small Business Program, please visit the 

Center for Devices and Radiological 

Health’s website: https://www.fda.gov/ 

medical-devices/premarketsubmissions/reduced-medical-deviceuser-fees-small-business-determinationsbd-program. 

For questions relating to this notice: 

Andrew Bank, Office of Financial 

Management, Food and Drug 

Administration, 4041 Powder Mill Rd., 

Rm. 62019A, Beltsville, MD 20705, 301– 

796–0292. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 738 of the FD&C Act (21 

U.S.C. 379j) establishes fees for certain 

medical device applications, 

submissions, supplements, notices, and 

requests (for simplicity, this document 

refers to these collectively as 

‘‘submissions’’ or ‘‘applications’’); for 

periodic reporting on class III devices; 

and for the registration of certain 

establishments. Under statutorily 

defined conditions, a qualified 

applicant may receive a fee waiver or 

may pay a lower small business fee (see 

21 U.S.C. 379j(d) and (e)). 

Under the FD&C Act, the fee rate for 

each type of submission is set at a 

specified percentage of the standard fee 

for a premarket application (a premarket 

application is a premarket approval 

application (PMA), a product 

development protocol (PDP), or a 

biologics license application (BLA)). 

The FD&C Act specifies the base fee for 

a premarket application for each year 

from FY 2018 through FY 2022; the base 

fee for a premarket application received 

by FDA during FY 2022 is $329,000. 

From this starting point, this document 

establishes FY 2022 fee rates for certain 

types of submissions, and for periodic 

reporting, by applying criteria specified 

in the FD&C Act. 

The FD&C Act specifies the base fee 

for establishment registration for each 

year from FY 2018 through FY 2022; the 

base fee for an establishment 

registration in FY 2022 is $4,978. There 

is no reduction in the registration fee for 

small businesses. Each establishment 

that is registered (or is required to 

register) with the Secretary of Health 

and Human Services under section 510 

of the FD&C Act (21 U.S.C. 360) because 

such establishment is engaged in the 

manufacture, preparation, propagation, 

compounding, or processing of a device 

is required to pay the annual fee for 

establishment registration. 

II. Revenue Amount for FY 2022 

The total revenue amount for FY 2022 

is $213,687,660, as set forth in the 

statute prior to the inflation adjustment 

(see 21 U.S.C. 379j(b)(3)). MDUFA 

directs FDA to use the yearly total 

revenue amount as a starting point to set 

the standard fee rates for each fee type. 

The fee calculations for FY 2022 are 

described in this document. 

Inflation Adjustment 

MDUFA specifies that the 

$213,687,660 is to be adjusted for 

inflation increases for FY 2022 using 

two separate adjustments—one for 

payroll costs and one for non-payroll 

costs (see 21 U.S.C. 379j(c)(2)). The base 

inflation adjustment for FY 2022 is the 

sum of one plus the two separate 

adjustments and is compounded as 

specified in the statute (see 21 U.S.C. 

379j(c)(2)(C) and 379j(c)(2)(B)). 

The component of the inflation 

adjustment for payroll costs is the 

average annual percent change in the 

cost of all personnel compensation and 

benefits (PC&B) paid per full-time 

equivalent position (FTE) at FDA for the 

first 3 of the 4 preceding FYs, 

multiplied by 0.60, or 60 percent (see 21 

U.S.C. 379j(c)(2)(C)). 

Table 1 summarizes the actual cost 

and FTE data for the specified FYs, and 

provides the percent change from the 

previous FY and the average percent 

change over the first 3 of the 4 FYs 

preceding FY 2022. The 3-year average 

is 2.7383 percent (rounded). 


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