Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices 44427 

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 Web site 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: On November 7, 2017, the 

committee will meet in an open session 

to discuss and make recommendations 

on the clinical development plan for 

Pfizer’s investigational Staphylococcus 

aureus vaccine intended for pre-surgical 

prophylaxis in elective orthopedic 

surgical populations. 

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 Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before October 31, 2017. 

Oral presentations from the public will 

be scheduled between approximately 

1:15 p.m. and 2:15 p.m. 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 

requested to make their presentation on 

or before October 23, 2017. 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 

October 24, 2017. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

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 Serina HunterThomas at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at: 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/

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: September 15, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–20240 Filed 9–21–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0016] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Recordkeeping 

and Records Access Requirements for 

Food Facilities 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by October 23, 

2017. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0560. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Recordkeeping and Records Access 

Requirements for Food Facilities—21 

CFR 1.337, 1.345, and 1.352 

OMB Control Number 0910–0560— 

Extension 

The Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002 (the Bioterrorism 

Act) added section 414 of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 350c), which 

requires that persons who manufacture, 

process, pack, hold, receive, distribute, 

transport, or import food in the United 

States establish and maintain records 

identifying the immediate previous 

sources and immediate subsequent 

recipients of food. Sections 1.326 

through 1.363 of our regulations (21 

CFR 1.326 through 1.363) set forth the 

requirements for recordkeeping and 

records access. The requirement to 

establish and maintain records improves 

our ability to respond to, and further 

contain, threats of serious adverse 

health consequences or death to humans 

or animals from accidental or deliberate 

contamination of food. 

Information maintained under these 

regulations will help us identify and 

locate quickly contaminated or 

potentially contaminated food and 

inform the appropriate individuals and 

food facilities of specific terrorist 

threats. Our regulations require that 

records for non-transporters include the 

name and full contact information of 

sources, recipients, and transporters; an 

adequate description of the food, 

including the quantity and packaging; 

and the receipt and shipping dates 

(§§ 1.337 and 1.345). Required records 

for transporters include the names of 

consignor and consignee, points of 

origin and destination, date of 

shipment, number of packages, 

description of freight, route of 

movement and name of each carrier 

participating in the transportation, and 

transfer points through which shipment 

moved (§ 1.352). Existing records may 

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