51902 Federal Register / Vol. 86, No. 178 / Friday, September 17, 2021 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN

FDA form; survey Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(hours) 

Total hours 

Biosimilar User Fee Cover Sheet (Form FDA 3792) .......... 60 1 60 0.5 (30 minutes).30 

Annual Survey ..................................................................... 60 1 60 1 ..................... 60 

Request for discontinuation from BPD program ................. 10 1 10 1 ..................... 10 

Request to move products to discontinued section of the 

Biosimilar List.

5 1 5 0.5 (30 minutes).2.5 

Biosimilar product applications (351(k)(2)(A)) ..................... 4 2.25 9 860 ................. 7,740 

Interchangeable product applications (351(k)(2)(B) ............ 2 1 2 860 ................. 1,720 

Patent infringement notifications ......................................... 4 2.25 9 2 ..................... 18 

Formal Meetings GFI Recommendations ........................... 69 2.30 159 21.42 .............. 3,405 

Total .............................................................................. ........................ ........................ 314 ........................ 12,985.5 

In anticipation of increased 

participation in the BPD program, we 

have increased our estimate to reflect an 

increase in the number of respondents 

since last OMB review. We have also 

made adjustments to reflect information 

collection consolidated from OMB 

control number 0910–0719. We invite 

comment on our estimates and 

assumptions. 

Dated: September 9, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–20060 Filed 9–16–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–0313] 

Agency Information Collection 

Request; 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, Health 

and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before October 18, 2021. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: 

Sherrette Funn, Sherrette.Funn@hhs.gov 

or (202) 795–7714. When submitting 

comments or requesting information, 

please include the document identifier 

0990–0313–30D and project title for 

reference. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: 2021 National 

Blood Collection & Utilization Survey. 

Type of Collection: Revision. 

OMB No. 0990–0313: Office of the 

Assistant Secretary for Health. 

Abstract: The 2021 National Blood 

Collection and Utilization Survey is a 

biennial survey of the blood collection 

and utilization community to produce 

reliable and accurate estimates of 

national and regional collections, 

utilization and safety of all blood 

products. The survey includes a core of 

standard questions on blood collection, 

processing, and utilization practices. 

The rapidly changing environment in 

blood supply and demand makes it 

important to have regular, periodic data 

describing the state of U.S. blood 

collections and transfusions for 

understanding the dynamics of blood 

safety and availability. Two sections 

were added to the survey to capture 

information on the impact of the 

COVID–19 pandemic on the blood 

supply during the course of 2020. The 

COVID–19 supplemental sections will 

only be included on the survey once. 

Survey respondents will consist of 

blood collection centers, cord blood 

banks, and hospitals that perform blood 

transfusions, except those reporting 

fewer than 100 inpatient surgeries per 

year. For the purposes of this ICR, 

federal burden is only being placed on 

facilities located within the fifty states 

and the District of Columbia. 

OMB approval is requested for three 

years. The total estimated annual 

burden is 4,532 hours. 

ESTIMATED ANNUALIZED BURDEN TABLE

Type of respondent Number of 

respondents 

Number 

responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Transfusing Hospitals ...................................................................................... 2,140 1 2 4,280 

Hospital Blood Banks ...................................................................................... 76 1 2 152 

Community-based blood center ....................................................................... 50 1 2 100 

Federal Register / Vol. 86, No. 178 / Friday, September 17, 2021 / Notices 51903 

ESTIMATED ANNUALIZED BURDEN TABLE—Continued 

Type of respondent Number of 

respondents 

Number 

responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Total .......................................................................................................... 2,266 ........................ ........................ 4,532 

Sherrette A. Funn, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. 2021–20183 Filed 9–16–21; 8:45 am] 

BILLING CODE 4150–41–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following 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 grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Initial 

Review Group; Neurological Sciences and 

Disorders C Study Section: Neurological 

Sciences and Disorders Panel–C (NSD–C). 

Date: October 6, 2021. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate 

cooperative agreement applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Virtual 

Meeting). 

Contact Person: Diana M. Cummings, 

Ph.D., Scientific Review Officer, Scientific 

Review Branch, National Institute of 

Neurological Disorders and Stroke, NIH, 

NSC, 6001 Executive Blvd., Suite 3208, 

Rockville, MD 20852, cummingsdi@

ninds.nih.gov. 

(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: September 13, 2021. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–20113 Filed 9–16–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; 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 National Cancer Institute 

Council of Research Advocates. 

The meeting will be held as a virtual 

meeting and is open to the public. 

Individuals who plan to view the virtual 

meeting and need special assistance or 

other reasonable accommodations to 

view the meeting, should notify the 

Contact Person listed below in advance 

of the meeting. The meeting will be 

videocast and can be accessed from the 

NIH Videocasting and Podcasting 

website (http://videocast.nih.gov). 

Name of Committee: National Cancer 

Institute Council of Research Advocates. 

Date: September 29, 2021. 

Time: 12:00 p.m. to 4:00 p.m. EST. 

Agenda: Welcome and Chairwoman’s 

Remarks, NCI Updates, Legislative Update, 

and Director’s Update. 

Place: National Institutes of Health, 9000 

Rockville Pike, Building 31, Bethesda, MD 

20892–2580 (Virtual Meeting). 

Contact Person: Amy Williams, NCI Office 

of Advocacy Relations, National Cancer 

Institute, NIH, 31 Center Drive, Building 31, 

Room 10A28, Bethesda, MD 20892–2850, 

(301) 496–9723, williaam@mail.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 

Institute’s/Center’s home page: NCRA: http:// 

deainfo.nci.nih.gov/advisory/ncra/ncra.htm, 

where an agenda and any additional 

information for the meeting will be posted 

when available. 

This notice is being published less than 15 

days prior to the meeting due to scheduling 

difficulties. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: September 13, 2021. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–20075 Filed 9–16–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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 grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Aging Special Emphasis Panel; Multi-site 

Clinical Trial Implementation. 

Date: November 2, 2021. 

Time: 10:00 a.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, 7201 Wisconsin Avenue, 

Bethesda, MD 20892 (Video Meeting). 

Contact Person: Isis S. Mikhail, MD, MPH, 

DrPH, Scientific Review Officer, Scientific 

Review Branch, National Institute on Aging, 

National Institutes of Health, Gateway 

Building 2C212, 7201 Wisconsin Avenue, 

Bethesda, MD 20892, (301) 402–7704, 

mikhaili@mail.nih.gov. 

Name of Committee: National Institute on 

Aging Special Emphasis Panel Triadic Care.