Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping and Records Access Requirements for Food Facilities, 44427-44428 [2017-20239]

Download as PDF Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices 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. VerDate Sep<11>2014 18:11 Sep 21, 2017 Jkt 241001 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. 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 SUMMARY: PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 44427 include the FDA docket number found in brackets in the heading of this document. 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. FOR FURTHER INFORMATION CONTACT: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: 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 E:\FR\FM\22SEN1.SGM 22SEN1 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 Number of recordkeepers 21 CFR section 1.337, 1.345, and 1.352 (Records maintenance) ............................................. 1.337, 1.345, and 1.352 (Learning for new firms) ........................................... Total ................................................ 1 There Number of records per recordkeeper Average burden per recordkeeping Total annual records Total hours 379,493 1 379,493 13.228 5,020,000 18,975 1 18,975 4.790 90,890 .............................. .............................. .............................. .............................. 5,110,890 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 VerDate Sep<11>2014 18:11 Sep 21, 2017 Jkt 241001 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 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. 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 SUMMARY: E:\FR\FM\22SEN1.SGM 22SEN1

Agencies

[Federal Register Volume 82, Number 183 (Friday, September 22, 2017)]
[Notices]
[Pages 44427-44428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20239]


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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 (Sec. Sec.  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 (Sec.  1.352). Existing records may

[[Page 44428]]

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 Sec.  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 Sec.  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 Sec.  1.361. Accordingly, 
we have not included an estimate of burden hours associated with Sec.  
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Number of      Number of records     Total annual      Average burden
                      21 CFR section                         recordkeepers     per recordkeeper       records       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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There 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
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