Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices 30963 

HRSA specifically requests comments 

on (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. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2021–12150 Filed 6–9–21; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–XXXX] 

Agency Information Collection 

Request; 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, 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 July 12, 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–New–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: Family 

Planning Annual Report 2.0. 

Type of Collection: New. 

OMB No.: 0990–NEW—Office of 

Population Affairs. 

Abstract: The Office of Population 

Affairs (OPA), within the Office of the 

Assistant Secretary for Health, seeks 

approval for a new 3-year encounter 

level data collection for the Family 

Planning Annual Report (FPAR). 

Currently collected in aggregate under 

OMB No. 0990–0221, this new data 

collection, ‘‘FPAR 2.0’’, will collect 

information at the encounter level and 

build on the existing data collection and 

reporting system. This annual reporting 

requirement is for competitively 

awarded grants authorized and funded 

by the Title X Family Planning Program. 

ESTIMATED ANNUALIZED BURDEN TABLE

Type of respondent Number of 

respondents 

Number 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden 

hours 

Grantees .......................................................................................................... 70 1 102 7140

Total .......................................................................................................... 70 1 102 7140 

Sherrette A. Funn, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. 2021–12113 Filed 6–9–21; 8:45 am] 

BILLING CODE 4150–34–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; 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 Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Clinical Trials SEP (UG3, U24, R61, R34). 

Date: July 21, 2021. 


khammond on DSKJM1Z7X2PROD with NOTICES
30964 Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6705 

Rockledge Drive, Bethesda, MD 20817 

(Virtual Meeting). 

Contact Person: Zhihong Shan, Ph.D., MD, 

Scientific Review Officer, Office of Scientific 

Review/DERA, National Heart, Lung, and 

Blood Institute, National Institutes of Health, 

6705 Rockledge Drive, Room 205–J, 

Bethesda, MD 20892, (301) 827–7085, 

zhihong.shan@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: June 4, 2021. 

David W. Freeman, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–12138 Filed 6–9–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; 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 Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Understanding and Reducing Cardiovascular 

Disease in Type 1 Diabetes Mellitus. 

Date: July 15, 2021. 

Time: 11:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6705 

Rockledge Drive, Bethesda, MD 20817 

(Virtual Meeting). 

Contact Person: Susan Wohler Sunnarborg, 

Ph.D., Scientific Review Officer, Office of 

Scientific Review/DERA, National Heart, 

Lung, and Blood Institute, National Institutes 

of Health, 6705 Rockledge Drive, Room 208– 

Z, Bethesda, MD 20892, (301) 827–7987, 

susan.sunnarborg@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: June 4, 2021. 

David W. Freeman, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–12142 Filed 6–9–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The invention listed below is 

owned by an agency of the U.S. 

Government and is available for 

licensing to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

FOR FURTHER INFORMATION CONTACT: 

Benjamin Hurley; tel. 240–669–5092; 

benjamin.hurley@nih.gov. Licensing 

information may be obtained by 

communicating with the Technology 

Transfer and Intellectual Property 

Office, National Institute of Allergy and 

Infectious Diseases, 5601 Fishers Lane, 

Rockville, MD 20852; tel. 301–496– 

2644. A signed Confidential Disclosure 

Agreement will be required to receive 

copies of unpublished information 

related to the invention. 

SUPPLEMENTARY INFORMATION: 

Technology description follows: 

FRugally Optimized DNA Octamer 

(FRODO): DNA Vector and Uses 

Thereof for Detecting HIV and SIV 

Description of Technology 

Quantitative polymerase chain 

reactions (qPCRs) are commonly 

employed to enumerate genes of interest 

among particular biological samples. 

Insertion of PCR amplicons into plasmid 

DNA is a mainstay for creation of 

known quantities of target sequences to 

standardize quantitative PCRs. 

Typically, one amplicon is inserted into 

one plasmid construct, the plasmid is 

then amplified, purified, serially 

diluted, and then quantified to be used 

to enumerate target sequences in 

unknown samples. As qPCR is often 

used to detect multiple amplicons 

simultaneously, individual qPCR 

standards are often desired to be 

normalized one to another. Unlike prior 

methods using separate plasmid 

constructs for each target sequence, 

FRODO incorporates eight amplicons 

into one plasmid construct ensuring 

equivalent template copy numbers for 

all amplicons. Amplifying, purifying, 

diluting and quantifying one plasmid 

construct rather than eight individual 

constructs streamlines standard curve 

qPCR analyses, reducing reagents and 

simplifying normalization between 

amplicons. 

This technology is available for 

licensing for commercial development 

in accordance with 35 U.S.C. 209 and 37 

CFR part 404, as well as for further 

development and evaluation under a 

research collaboration. 

Potential Commercial Applications 

• Clinical Detection, Monitoring of 

Nucleic Acid Markers of HIV and 

Immunological Health: FRODO may be 

used to efficiently quantify target 

sequences in unknown samples. 

• FRODO is a single plasmid 

containing 8 amplicons which can be 

used to quantify several different strains 

of SIV and HIV, cell number equivalents 

for humans and nonhuman primates, T 

cell receptor excision circles (humans 

and nonhuman primates), and bacterial 

16S and ampicillin resistance DNA. 

• FRODO may offer improved, more 

affordable, highly-sensitive nucleic 

acid-based HIV quantification and/or 

diagnostic response times, enhancing 

patient treatment and interventions. 

• FRODO can be used to quantify 

levels of bacterial DNA in clinical 

samples to determine potential sepsis. 

• This technology is especially useful 

in translational HIV research in which 

human and nonhuman primate models 

are used to study HIV pathogenesis, 

informing public health responses. 

Competitive Advantages 

• A simplified workflow for qPCR 

testing. Amplifying, purifying, diluting 

and quantifying one plasmid construct 

rather than multiple, individual 

constructs streamlines standard curve 

qPCR analyses, reducing reagents and 

simplifying normalization between 

amplicons. 

• At present, there are a number of 

antibody-based clinical tools that may 

be used for diagnosing/detecting HIV, 

but there are fewer products that 

affordably detect/monitor nucleic acids 

of HIV within cells, and immunological 

health, and efficacy of medicaments 


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