44428 Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices 

be used if they contain all of the 

required information and are retained 

for the required time period. 

Section 101 of the FDA Food Safety 

Modernization Act (FSMA) (Pub. L. 

111–353) amended section 414(a) of the 

FD&C Act and expanded our access to 

records. Specifically, FSMA expanded 

our access to records beyond records 

relating to the specific suspect article of 

food to records relating to any other 

article of food that we reasonably 

believe is likely to be affected in a 

similar manner. In addition, we can 

access records if we believe that there is 

a reasonable probability that the use of 

or exposure to an article of food, and 

any other article of food that we 

reasonably believe is likely to be 

affected in a similar manner, will cause 

serious adverse health consequences or 

death to humans or animals. To gain 

access to these records, our officer or 

employee must present appropriate 

credentials and a written notice, at 

reasonable times and within reasonable 

limits and in a reasonable manner. 

On February 23, 2012, we issued an 

interim final rule in the Federal 

Register (77 FR 10658) (the 2012 IFR) 

amending § 1.361 to be consistent with 

the current statutory language in section 

414(a) of the FD&C Act, as amended by 

section 101 of FSMA. In the 2012 IFR, 

we concluded that the information 

collection provisions of § 1.361 were 

exempt from OMB review under 44 

U.S.C. 3518(c)(1)(B)(ii) and 5 CFR 

1320.4(a)(2) as collections of 

information obtained during the 

conduct of a civil action to which the 

United States or any official or agency 

thereof is a party, or during the conduct 

of an administrative action, 

investigation, or audit involving an 

agency against specific individuals or 

entities (77 FR 10658 at 10661). The 

interim final rule was made final, 

without change, on April 4, 2014 (79 FR 

18799). The regulations at 5 CFR 

1320.3(c) provide that the exception in 

5 CFR 1320.4(a)(2) applies during the 

entire course of the investigation, audit, 

or action, but only after a case file or 

equivalent is opened with respect to a 

particular party. Such a case file would 

be opened as part of the request to 

access records under § 1.361. 

Accordingly, we have not included an 

estimate of burden hours associated 

with § 1.361 in table 1. 

Description of Respondents: Persons 

that manufacture, process, pack, hold, 

receive, distribute, transport, or import 

food in the United States are required to 

establish and maintain records, 

including persons that engage in both 

interstate and intrastate commerce. 

In the Federal Register of June 14, 

2017 (82 FR 27263), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received one 

comment. The comment was supportive 

of the information collection but 

requested that FDA coordinate with the 

U.S. Department of Agriculture. FDA 

addresses issues regarding duplication 

of information collection in question 4 

of the Agency’s supporting statement. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

1.337, 1.345, and 1.352 (Records maintenance) ............................................. 379,493 1 379,493 13.228 5,020,000 

1.337, 1.345, and 1.352 (Learning for 

new firms) ........................................... 18,975 1 18,975 4.790 90,890 

Total ................................................ .............................. .............................. .............................. .............................. 5,110,890 

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

This estimate is based on our estimate 

of the number of facilities affected by 

the final rule entitled ‘‘Establishment 

and Maintenance of Records Under the 

Public Health Security and Bioterrorism 

Preparedness and Response Act of 

2002,’’ published in the Federal 

Register of December 9, 2004 (69 FR 

71562 at 71650). With regard to records 

maintenance, we estimate that 

approximately 379,493 facilities will 

spend 13.228 hours collecting, 

recording, and checking for accuracy the 

limited amount of additional 

information required by the regulations, 

for a total of 5,020,000 hours annually. 

In addition, we estimate that new firms 

entering the affected businesses will 

incur a burden from learning the 

regulatory requirements and 

understanding the records required for 

compliance. In this regard, we estimate 

the number of new firms entering the 

affected businesses to be 5 percent of 

379,493, or 18,975 firms. Thus, we 

estimate that approximately 18,975 

facilities will spend 4.790 hours 

learning about the recordkeeping and 

records access requirements, for a total 

of 90,890 hours annually. We estimate 

that approximately the same number of 

firms (18,975) will exit the affected 

businesses in any given year, resulting 

in no growth in the number of total 

firms reported on line 1 of table 1. 

Therefore, the total annual 

recordkeeping burden is estimated to be 

5,110,890 hours. 

Dated: September 15, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–20239 Filed 9–21–17; 8:45 am] 

BILLING CODE 4164–01–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 inventions listed below 

are owned by an agency of the U.S. 

Government and are 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: 

Chris Kornak, 240–627–3705, 

chris.kornak@nih.gov. Licensing 

Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices 44429 

information and copies of the U.S. 

patent applications listed below may be 

obtained by communicating with the 

indicated licensing contact at the 

Technology Transfer and Intellectual 

Property Office (TTIPO), 5601 Fishers 

Lane, Suite 6D, MSC 9804, Rockville, 

MD 20892, tel: 301–496–2644, fax: 240– 

627–3117. A signed Confidential 

Disclosure Agreement will be required 

to receive copies of unpublished patent 

applications. 

SUPPLEMENTARY INFORMATION: 

Technology descriptions follow. 

Research Material: A Potent, BroadlyNeutralizing, Anti-HIV Antibody 

(35O22) That Binds a Novel Epitope 

Description of Technology: Millions of 

people are infected with HIV–1 

worldwide. In the U.S., there are about 

30,000 new cases of HIV infection 

reported annually. Researchers at NIAID 

are actively investigating broadly 

neutralizing anti-HIV–1 antibodies 

which can be used as therapeutics or 

prophylactics for HIV infection. 

NIAID and Scripps researchers have 

discovered a potent anti-HIV antibody 

(35O22) that binds a novel HIV epitope. 

This antibody neutralizes at least 80% 

of HIV isolates tested so far. The unique 

binding of 35O22 makes it an attractive 

candidate to combine with other HIV 

antibodies or antivirals in treating or 

preventing HIV infection. 

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: 

• HIV–1 therapeutics 

• HIV–1 prophylactics 

Competitive Advantages: 

• Unique epitope 

• Broad neutralization of HIV isolates 

Development Stage: Pre-Clinical. 

Inventors: Mark Connors, John 

Mascola, Peter Kwong, Tongqing Zhou, 

Jinghe Huang, Byong Ha Kang, all of 

NIAID, NIH; Andrew Ward, Scripps 

Research Institute. 

Publications: Huang, J et al., Broad 

and potent HIV–1 neutralization by a 

human antibody that binds the gp41– 

gp120 interface. Nature 515, 138–142. 

Intellectual Property: Not applicable. 

Licensing Contact: Chris Kornak, 240– 

627–3705, chris.kornak@nih.gov. 

Collaborative Research Opportunity: 

The Technology Transfer and 

Intellectual Property Office (TTIPO) is 

seeking parties interested in 

collaborative research to further develop 

35O22 in combination with other NIAID 

antibodies. For collaboration 

opportunities, please contact Chris 

Kornak, 240–627–3705, chris.kornak@

nih.gov. 

Dated: September 12, 2017. 

Suzanne Frisbie, 

Deputy Director, Technology Transfer and 

Intellectual Property Office, National Institute 

of Allergy and Infectious Diseases. 

[FR Doc. 2017–20232 Filed 9–21–17; 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 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 on 

Aging Special Emphasis Panel; Drug 

Repurposing for Alzheimer’s Disease. 

Date: October 17, 2017. 

Time: 10:30 a.m. to 12:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, Suite 2W200, 7201 

Wisconsin Avenue, Bethesda, MD 20814 

(Telephone Conference Call). 

Contact Person: Anita H. Undale, Ph.D., 

MD, Scientific Review Branch, National 

Institute on Aging, Gateway Building, Suite 

2W200, 7201 Wisconsin Avenue, Bethesda, 

MD 20892, 240–747–7825, anita.undale@

nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: September 18, 2017. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–20230 Filed 9–21–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Eye 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 Eye Institute 

Special Emphasis Panel NEI; Institutional 

Training Grant Applications. 

Date: October 16, 2017. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Garden Inn Bethesda, 7301 

Waverly Street, Bethesda, MD 20814. 

Contact Person: Jeanette M. Hosseini, 

Ph.D., Scientific Review Officer, NEI/DEA/ 

SRB, National Institutes of Health, 5635 

Fishers Lane, Suite 1300, Bethesda, MD 

20892, 301–451–2020, jeanetteh@

mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.867, Vision Research, 

National Institutes of Health, HHS) 

Dated: September 18, 2017. 

Natasha M. Copeland, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–20178 Filed 9–21–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

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National Institutes of Health 

National Cancer Institute; 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,