47314 Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / Notices 

The total burden is estimated to be 

235.5 hours. 

Exhibit 2 shows the estimated 

annualized cost burden based on the 

respondents’ time to submit their data. 

The cost burden is estimated to be 

$12,312 annually. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name 

Number of 

respondents/ 

POCs 

Number of 

responses 

per POC 

Hours per 

response 

Total burden 

hours 

Eligibility/Registration Form ............................................................................. 85 1 3/60 4.25 

Data Use Agreement ....................................................................................... 85 1 3/60 4.25 

Medical Office Information Form ..................................................................... 85 20 5/60 142 

Data Files Submission ..................................................................................... 85 1 1 85 

Total .......................................................................................................... NA NA NA 235.5 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name 

Number of 

respondents/ 

POCs 

Total burden 

hours 

Average 

hourly wage 

rate * 

Total cost 

burden 

Registration Form ............................................................................................ 85 4.25 $52.28 $222 

Data Use Agreement ....................................................................................... 85 4.25 52.28 222 

Medical Office Information Form ..................................................................... 85 142 52.28 7,424 

Data Files Submission ..................................................................................... 85 85 52.28 4,444 

Total .......................................................................................................... NA 235.5 NA 12,312 

* Mean hourly wage rate of $52.28 for Medical and Health Services Managers (SOC code 11–9111) was obtained from the May 2019 National 

Industry-Specific Occupational Employment and Wage Estimates, NAICS 621100—Offices of Physicians located at https://www.bls.gov/oes/current/naics4_621100.htm. 

Request for Comments 

In accordance with the Paperwork 

Reduction Act, comments on AHRQ’s 

information collection are requested 

with regard to any of the following: (a) 

Whether the proposed collection of 

information is necessary for the proper 

performance of AHRQ’s health care 

research and health care information 

dissemination functions, including 

whether the information will have 

practical utility; (b) the accuracy of 

AHRQ’s estimate of burden (including 

hours and costs) of the proposed 

collection(s) of information; (c) ways to 

enhance the quality, utility and clarity 

of the information to be collected; and 

(d) ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: August 18, 2021. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2021–18126 Filed 8–23–21; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0856] 

Vaccines and Related Biological 

Products 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 or Agency) 

announces a forthcoming public 

advisory committee meeting of the 

Vaccines and Related Biological 

Products Advisory Committee 

(VRBPAC). The general function of the 

committee is to provide advice and 

recommendations to FDA on regulatory 

issues. Members will participate via 

teleconference. At least one portion of 

the meeting will be closed to the public. 

FDA is establishing a docket for public 

comment on this document. 

DATES: The meeting will be held on 

September 30, 2021, from 8:30 a.m. to 

3:40 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. The 

online web conference meeting will be 

available at the following link on the 

day of the meeting: https://youtu.be/ 

VeknygU5MKM. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2021–N–0856. 

The docket will close on September 29, 

2021. Submit either electronic or 

written comments on this public 

meeting by September 29, 2021. Please 

note that late, untimely filed comments 

will not be considered. Electronic 

comments must be submitted on or 

before September 29, 2021. The https:// 

www.regulations.gov electronic filing 

system will accept comments until 

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

September 29, 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 

September 23, 2021, and by September 

29, 2021, will be taken into 

consideration by FDA. In the event that 

the meeting is canceled, FDA will 

continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 


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Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / Notices 47315 

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–0856 for ‘‘Vaccines and Related 

Biological Products; 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: 

Kathleen Hayes or Monique Hill, Center 

for Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

6307C, Silver Spring, MD 20993–0002, 

301–796–7864, Kathleen.Hayes@

fda.hhs.gov, or 301–796–4620, 

Monique.Hill@fda.hhs.gov, respectively; 

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 Agency’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 30, 2021, under Topic I, the 

committee will meet in open session to 

hear an overview of the research 

programs in the Laboratory of Bacterial 

Polysaccharides, Division of Bacterial, 

Parasitic, and Allergenic Products, 

Office of Vaccines Research and Review, 

and the Center for Biologics Evaluation 

and Research (CBER). Also, on 

September 30, 2021, under Topic II, 

CBER’s VRBPAC will meet in open 

session to discuss and make 

recommendations on the selection of 

strains to be included in the influenza 

virus vaccines for the 2021 to 2022 

southern hemisphere influenza season. 

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, 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/ 

advisory-committees/advisorycommittee-calendar. 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: On September 30, 2021, 

under Topic I, from 8:30 a.m. to 10:45 

a.m. the meeting is open to the public. 

On September 30, 2021, under Topic II, 

from 12:15 p.m. to 3:40 p.m. the meeting 

is open to the public. 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 10:15 a.m. and 10:45 a.m. 

under Topic I and from 2:10 p.m. and 

2:40 p.m. under Topic II. 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 


lotter on DSK11XQN23PROD with NOTICES1
47316 Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / Notices 

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. 

Closed Committee Deliberations: On 

September 30, 2021, from 10:45 a.m. to 

11:45 a.m., the meeting will be closed to 

permit discussion where disclosure 

would constitute a clearly unwarranted 

invasion of personal privacy (5 U.S.C. 

552b(c)(6)). The recommendations of the 

advisory committee regarding the 

progress of the individual investigator’s 

research programs along with other 

information, will be discussed during 

this session. We believe that public 

discussion of these recommendations on 

individual scientists would constitute 

an unwarranted invasion of personal 

privacy. 

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 Kathleen 

Hayes (CBERVRBPAC@fda.hhs.gov) 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/about-advisory-committees/ 

public-conduct-during-fda-advisorycommittee-meetings 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 18, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–18107 Filed 8–23–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0891] 

Reauthorization of the Prescription 

Drug User Fee Act; Public Meeting; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is hosting a virtual public meeting 

entitled ‘‘Reauthorization of the 

Prescription Drug User Fee Act.’’ The 

purpose of the public meeting is to 

discuss proposed recommendations for 

the reauthorization of the Prescription 

Drug User Fee Act (PDUFA) for fiscal 

years (FYs) 2023 through 2027. PDUFA 

authorizes FDA to collect user fees to 

support the process for the review of 

human drug applications. The current 

legislative authority for PDUFA expires 

in September 2022. At that time, new 

legislation will be required for FDA to 

continue collecting prescription drug 

user fees in future fiscal years. 

Following discussions with the 

regulated industry and periodic 

consultations with public stakeholders, 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) directs FDA to publish 

the recommendations for the 

reauthorized program in the Federal 

Register, hold a meeting at which the 

public may present its views on such 

recommendations, and provide for a 

period of 30 days for the public to 

provide written comments on such 

recommendations. FDA will then 

consider such public views and 

comments and revise such 

recommendations, as necessary. 

DATES: The public meeting will be held 

on September 28, 2021, from 9 a.m. to 

2 p.m. Eastern Time, and will be held 

by webcast only. Submit either 

electronic or written comments on this 

public meeting by October 28, 2021. 

ADDRESSES: Registration to attend the 

virtual meeting and other information 

can be found at https://pdufaviireauthorization.eventbrite.com. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

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 October 28, 2021. The 

https://www.regulations.gov electronic 

filing system will accept comments 

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

of October 28, 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. 

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–0891 for ‘‘Reauthorization of 

the Prescription Drug User Fee Act; 

Public Meeting; 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 


lotter on DSK11XQN23PROD with NOTICES1