82 FR 27263 - Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping and Records Access Requirements for Food Facilities
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 113 (June 14, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 113 (June 14, 2017)
| Page Range | 27263-27265 | |
| FR Document | 2017-12327 |
[Federal Register Volume 82, Number 113 (Wednesday, June 14, 2017)] [Notices] [Pages 27263-27265] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-12327] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0016] Agency Information Collection Activities; Proposed Collection; 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 or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of our recordkeeping and records access requirements for food facilities. DATES: Submit either electronic or written comments on the collection of information by August 14, 2017. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 14, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of August 14, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov/. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov/ will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov/. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2011-N-0016 for ``Recordkeeping and Records Access Requirements for Food Facilities.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov/ or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov/. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov/ and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. [[Page 27264]] With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. 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 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 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. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average burden 21 CFR section Number of records per Total annual per Total hours recordkeepers recordkeeper records recordkeeping ---------------------------------------------------------------------------------------------------------------- 1.337, 1.345, and 1.352 (Records 379,493 1 379,493 13.228 5,020,000 maintenance)................... 1.337, 1.345, and 1.352 18,975 1 18,975 4.790 90,890 (Learning for new firms)....... ------------------------------------------------------------------------------- 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 of 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 [[Page 27265]] 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: June 9, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-12327 Filed 6-13-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Notices 27263
5630 Fishers Lane, Rm. 1061, Rockville, the instructions for submitting claimed confidential information, in our
MD 20852. comments. Comments submitted consideration of comments. The second
Dated: June 9, 2017. electronically, including attachments, to copy, which will have the claimed
Anna K. Abram,
https://www.regulations.gov/ will be confidential information redacted/
posted to the docket unchanged. blacked out, will be available for public
Deputy Commissioner for Policy, Planning,
Because your comment will be made viewing and posted on https://
Legislation, and Analysis.
public, you are solely responsible for www.regulations.gov/. Submit both
[FR Doc. 2017–12323 Filed 6–13–17; 8:45 am]
ensuring that your comment does not copies to the Division of Dockets
BILLING CODE 4164–01–P
include any confidential information Management. If you do not wish your
that you or a third party may not wish name and contact information to be
to be posted, such as medical made publicly available, you can
DEPARTMENT OF HEALTH AND
information, your or anyone else’s provide this information on the cover
HUMAN SERVICES Social Security number, or confidential sheet and not in the body of your
Food and Drug Administration business information, such as a comments and you must identify this
manufacturing process. Please note that information as ‘‘confidential.’’ Any
[Docket No. FDA–2011–N–0016] if you include your name, contact information marked as ‘‘confidential’’
information, or other information that will not be disclosed except in
Agency Information Collection identifies you in the body of your accordance with 21 CFR 10.20 and other
Activities; Proposed Collection; comments, that information will be applicable disclosure law. For more
Comment Request; Recordkeeping posted on https://www.regulations.gov/. information about FDA’s posting of
and Records Access Requirements for If you want to submit a comment with comments to public dockets, see 80 FR
Food Facilities confidential information that you do not 56469, September 18, 2015, or access
AGENCY: Food and Drug Administration, wish to be made available to the public, the information at: https://www.gpo.gov/
HHS. submit the comment as a written/paper fdsys/pkg/FR-2015-09-18/pdf/2015-
submission and in the manner detailed 23389.pdf.
ACTION: Notice.
(see ‘‘Written/Paper Submissions’’ and Docket: For access to the docket to
SUMMARY: The Food and Drug ‘‘Instructions’’).
read background documents or the
Administration (FDA or Agency) is Written/Paper Submissions electronic and written/paper comments
announcing an opportunity for public received, go to https://
comment on the proposed collection of Submit written/paper submissions as
follows: www.regulations.gov/ and insert the
certain information by the Agency. docket number, found in brackets in the
• Mail/Hand delivery/Courier (for
Under the Paperwork Reduction Act of heading of this document, into the
written/paper submissions): Division of
1995 (PRA), Federal Agencies are ‘‘Search’’ box and follow the prompts
Dockets Management (HFA–305), Food
required to publish notice in the and/or go to the Division of Dockets
and Drug Administration, 5630 Fishers
Federal Register concerning each Management, 5630 Fishers Lane, Rm.
Lane, Rm. 1061, Rockville, MD 20852.
proposed collection of information, • For written/paper comments 1061, Rockville, MD 20852.
including each proposed extension of an submitted to the Division of Dockets
existing collection of information, and FOR FURTHER INFORMATION CONTACT:
Management, FDA will post your JonnaLynn Capezzuto, Office of
to allow 60 days for public comment in comment, as well as any attachments,
response to the notice. This notice Operations, Food and Drug
except for information submitted, Administration, Three White Flint
solicits comments on the information marked and identified, as confidential,
collection provisions of our North, 10A63, 11601 Landsdown St.,
if submitted as detailed in North Bethesda, MD 20852, 301–796–
recordkeeping and records access ‘‘Instructions.’’
requirements for food facilities. 3794.
Instructions: All submissions received
DATES: Submit either electronic or must include the Docket No. FDA– SUPPLEMENTARY INFORMATION: Under the
written comments on the collection of 2011–N–0016 for ‘‘Recordkeeping and PRA (44 U.S.C. 3501–3520), Federal
information by August 14, 2017. Records Access Requirements for Food Agencies must obtain approval from the
ADDRESSES: You may submit comments Facilities.’’ Received comments, those Office of Management and Budget
as follows. Please note that late, filed in a timely manner (see (OMB) for each collection of
untimely filed comments will not be ADDRESSES), will be placed in the docket information they conduct or sponsor.
considered. Electronic comments must and, except for those submitted as ‘‘Collection of information’’ is defined
be submitted on or before August 14, ‘‘Confidential Submissions,’’ publicly in 44 U.S.C. 3502(3) and 5 CFR
2017. The https://www.regulations.gov viewable at https:// 1320.3(c) and includes Agency requests
electronic filing system will accept www.regulations.gov/ or at the Division or requirements that members of the
comments until midnight Eastern Time of Dockets Management between 9 a.m. public submit reports, keep records, or
at the end of August 14, 2017. and 4 p.m., Monday through Friday. provide information to a third party.
Comments received by mail/hand • Confidential Submissions—To Section 3506(c)(2)(A) of the PRA (44
delivery/courier (for written/paper submit a comment with confidential U.S.C. 3506(c)(2)(A)) requires Federal
submissions) will be considered timely information that you do not wish to be Agencies to provide a 60-day notice in
if they are postmarked or the delivery made publicly available, submit your the Federal Register concerning each
service acceptance receipt is on or comments only as a written/paper proposed collection of information,
mstockstill on DSK30JT082PROD with NOTICES
before that date. submission. You should submit two including each proposed extension of an
copies total. One copy will include the existing collection of information,
Electronic Submissions information you claim to be confidential before submitting the collection to OMB
Submit electronic comments in the with a heading or cover note that states for approval. To comply with this
following way: ‘‘THIS DOCUMENT CONTAINS requirement, FDA is publishing notice
• Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ We of the proposed collection of
https://www.regulations.gov/. Follow will review this copy, including the information set forth in this document.
VerDate Sep<11>2014 17:36 Jun 13, 2017 Jkt 241001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\14JNN1.SGM 14JNN1](https://thefederalregister.org/doc/82_FR_27376/page/1.svg)
![Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Notices 27265
379,493, or 18,975 firms. Thus, we nominations should be sent to Margaret III. Selection Procedure
estimate that approximately 18,975 Ames (see FOR FURTHER INFORMATION
facilities will spend 4.790 hours CONTACT). All nominations for Any industry organization interested
learning about the recordkeeping and nonvoting industry representatives in participating in the selection of an
records access requirements, for a total should be submitted electronically by appropriate nonvoting member to
of 90,890 hours annually. We estimate accessing FDA’s Advisory Committee represent industry interests should send
that approximately the same number of Membership Nomination Portal at a letter stating that interest to the FDA
firms (18,975) will exit the affected https://www.accessdata.fda.gov/scripts/ contact (see FOR FURTHER INFORMATION
businesses in any given year, resulting FACTRSPortal/FACTRS/index.cfm or by CONTACT) within 30 days of publication
in no growth in the number of total mail to Advisory Committee Oversight of this document (see DATES). Within the
firms reported on line 1 of table 1. and Management Staff, Food and Drug subsequent 30 days, FDA will send a
Therefore, the total annual Administration, 10903 New Hampshire letter to each organization that has
recordkeeping burden is estimated to be Ave., Bldg. 32, Rm. 5103, Silver Spring, expressed an interest, attaching a
5,110,890 hours. MD 20993–0002. Information about complete list of all such organizations,
Dated: June 9, 2017. becoming a member of an FDA advisory and a list of all nominees along with
Anna K. Abram,
committee can also be obtained by their current resumes. The letter will
visiting FDA’s Web site at https:// also state that it is the responsibility of
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
www.fda.gov/AdvisoryCommittees/ the interested organizations to confer
default.htm. with one another and to select a
[FR Doc. 2017–12327 Filed 6–13–17; 8:45 am]
BILLING CODE 4164–01–P FOR FURTHER INFORMATION CONTACT: candidate, within 60 days after the
Margaret Ames, Office of Management, receipt of the FDA letter, to serve as the
Center for Devices and Radiological nonvoting member to represent industry
DEPARTMENT OF HEALTH AND Health, Food and Drug Administration, interests for the committee. The
HUMAN SERVICES 10903 New Hampshire Ave., Bldg. 66, interested organizations are not bound
Rm. 5264, Silver Spring, MD 20993, by the list of nominees in selecting a
Food and Drug Administration 301–796–5960, FAX: 301–847–8505, candidate. However, if no individual is
[Docket No. FDA–2017–N–2463] email: margaret.ames@fda.hhs.gov. selected within the 60 days, the
SUPPLEMENTARY INFORMATION: Section Commissioner of Food and Drugs will
Request for Nominations on Device 520 of the Federal Food, Drug and select the nonvoting member to
Good Manufacturing Practice Advisory Cosmetic Act (21 U.S.C. 360j), as represent industry interests.
Committee amended, provides that DGMPAC shall
be composed of two representatives of IV. Application Procedure
AGENCY: Food and Drug Administration,
interests of the device manufacturing
HHS. Individuals may self-nominate and/or
industry. The Agency is requesting
ACTION: Notice. nominations for a nonvoting industry an organization may nominate one or
representative on DGMPAC. FDA is more individuals to serve as a nonvoting
SUMMARY: The Food and Drug industry representative. Contact
Administration (FDA) is requesting that publishing a separate document
announcing the request for notification information, a current curriculum vitae,
any industry organization interested in and the name of the committee of
participating in the selection of a for voting members on DGMPAC.
interest should be sent to the FDA
nonvoting industry representative to I. Function of DGMPAC Advisory Committee Membership
serve on the Device Good
DGMPAC reviews proposed Nomination Portal (see ADDRESSES)
Manufacturing Practice Advisory
regulations issuance regarding good within 30 days of publication of this
Committee (DGMPAC) in the Center for
manufacturing practices governing the document (see DATES). FDA will forward
Devices and Radiological Health notify
methods used in, and the facilities and all nominations to the organizations
FDA in writing. FDA is also requesting
controls used for, the manufacture, expressing interest in participating in
nominations for a nonvoting industry
packaging, storage, installation, and the selection process for the committee.
representative to serve on DGMPAC. A
servicing of devices, and makes (Persons who nominate themselves as
nominee may either be self-nominated
recommendations regarding the nonvoting industry representatives will
or nominated by an organization to
feasibility and reasonableness of those not participate in the selection process).
serve as a nonvoting industry
proposed regulations. The committee
representative. Nominations will be FDA seeks to include the views of
also reviews and makes
accepted for the upcoming vacancy women and men, members of all racial
recommendations on proposed
effective with this notice. and ethnic groups, and individuals with
guidelines developed to assist the
DATES: Any industry organizations medical device industry in meeting the and without disabilities on its advisory
interested in participating in the good manufacturing practice committees and, therefore, encourages
selection of an appropriate nonvoting requirements, and provides advice with nominations of appropriately qualified
member to represent industry interests regard to any petition submitted by a candidates from these groups.
must send a letter stating that interest to manufacturer for an exemption or Specifically, in this document,
FDA by July 14, 2017 (see sections I and variance from good manufacturing nominations for nonvoting
III of this document for further details). practice regulations.
mstockstill on DSK30JT082PROD with NOTICES
representatives of industry interests are
Concurrently, nomination materials for encouraged from the device
prospective candidates should be sent to II. Qualifications
manufacturing industry.
FDA by July 14, 2017. Persons nominated for DGMPAC
ADDRESSES: All statements of interest should possess appropriate This notice is issued under the
from industry organizations interested qualifications to understand and Federal Advisory Committee Act (5
in participating in the selection process contribute to the committee’s work as U.S.C. app. 2) and 21 CFR part 14,
of nonvoting industry representative described in the committee’s function. relating to advisory committees.
VerDate Sep<11>2014 17:36 Jun 13, 2017 Jkt 241001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\14JNN1.SGM 14JNN1](https://thefederalregister.org/doc/82_FR_27376/page/3.svg)
Document Created: 2017-06-14 01:23:46
Document Modified: 2017-06-14 01:23:46
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by August 14, 2017. | |
| Contact | JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794. | |
| FR Citation | 82 FR 27263 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR