82 FR 26489 - Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 108 (June 7, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 108 (June 7, 2017)
| Page Range | 26489-26492 | |
| FR Document | 2017-11821 |
[Federal Register Volume 82, Number 108 (Wednesday, June 7, 2017)] [Notices] [Pages 26489-26492] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-11821] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0501] Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) 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 FDA's third party disclosure and recordkeeping requirements for reportable food. DATES: Submit either electronic or written comments on the collection of information by August 7, 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 7, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of August 7, 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. [[Page 26490]] 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-2009-N-0501 for ``Third Party Disclosure and Recordkeeping Requirements for Reportable Food.'' 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.'' The Agency will review this copy, including the claimed confidential information, in its 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: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]. 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. 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. Third Party Disclosure and Recordkeeping Requirements for Reportable Food--21 U.S.C. 350f; OMB Control Number 0910-0643--Extension The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110-85), requires the establishment of a Reportable Food Registry (the Registry) by which instances of reportable food must be submitted to FDA by responsible parties and may be submitted by public health officials. Section 417 of the FD&C Act (21 U.S.C. 350f) defines ``reportable food'' as an ``article of food (other than infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.'' (Section 417(a)(2) of the FD&C Act.) We believe that the most efficient and cost effective means to implement the Registry is by utilizing our electronic Safety Reporting Portal. The information collection provisions associated with the submission of reportable food reports has been approved under OMB control number 0910-0643. In conjunction with the reportable foods requirements, section 417 of the FD&C Act also establishes third party disclosure and recordkeeping burdens. Specifically, we may require the responsible party to notify the immediate previous source(s) and/or immediate subsequent recipient(s) of a reportable food (section 417(d)(6)(B)(i) to (ii) of the FD&C Act). Similarly, we may also require the responsible party that is notified (i.e., the immediate [[Page 26491]] previous source and/or immediate subsequent recipient) to notify their own immediate previous source(s) and/or immediate subsequent recipient(s) of a reportable food (section 417(d)(7)(C)(i) to (ii) of the FD&C Act). Notification to the immediate previous source(s) and immediate subsequent recipient(s) of the article of food may be accomplished by electronic communication methods such as email, fax, or text messaging or by telegrams, mailgrams, or first-class letters. Notification may also be accomplished by telephone call or other personal contacts but we recommend that such notifications also be confirmed by one of the previous methods and/or documented in an appropriate manner. We may require that the notification include any or all of the following data elements: (1) The date on which the article of food was determined to be a reportable food; (2) a description of the article of food including the quantity or amount; (3) the extent and nature of the adulteration; (4) the results of any investigation of the cause of the adulteration if it may have originated with the responsible party, if known; (5) the disposition of the article of food, when known; (6) product information typically found on packaging including product codes, use-by dates, and the names of manufacturers, packers, or distributors sufficient to identify the article of food; (7) contact information for the responsible party; (8) contact information for parties directly linked in the supply chain and notified under section 417(d)(6)(B) or 417(d)(7)(C) of the FD&C Act, as applicable; (9) the information required by FDA to be included in the notification provided by the responsible party involved under section 417(d)(6)(B) or 417(d)(7)(C) of the FD&C Act or required to report under section 417(d)(7)(A) of the FD&C Act; and (10) the unique number described in section 417(d)(4) of the FD&C Act (section 417(d)(6)(B)(iii)(I), (d)(7)(C)(iii)(I), and (e) of the FD&C Act). We may also require that the notification provides information about the actions that the recipient of the notification will perform and/or any other information we may require (section 417(d)(6)(B)(iii)(II) and (III), (d)(7)(C)(iii)(II) and (III) of the FD&C Act). Section 417(g) of the FD&C Act requires that responsible persons maintain records related to reportable foods for a period of 2 years. The congressionally identified purpose of the Registry is to provide ``a reliable mechanism to track patterns of adulteration in food [which] would support efforts by the Food and Drug Administration to target limited inspection resources to protect the public health'' (FDAAA, section 1005(a)(4)). The reporting and recordkeeping requirements described previously are designed to enable FDA to quickly identify and track an article of food (other than infant formula) for which there is a reasonable probability that the use of or exposure to such article of food will cause serious adverse health consequences or death to humans or animals. We use the information collected under these regulations to help ensure that such products are quickly and efficiently removed from the market. As required under section 1005(f) of FDAAA and to assist industry, we have issued the guidance document entitled, ``Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007,'' which is available at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm180761.htm. The guidance contains questions and answers relating to the requirements under section 417 of the FD&C Act, including: (1) How, when and where to submit reports to FDA; (2) who is required to submit reports to FDA; (3) what is required to be submitted to FDA; and (4) what may be required when providing notifications to other persons in the supply chain of an article of food. The guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in questions 20 and 21 of the guidance have been approved under OMB control number 0910-0249. Description of Respondents: Mandatory respondents to this collection of information are the owners, operators, or agents in charge of a domestic or foreign facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States (``responsible parties'') who have information on a reportable food. Voluntary respondents to this collection of information are Federal, State, and local public health officials who have information on a reportable food. We estimate the burden of this collection of information as follows: Table 1--Estimated Annual Third-Party Disclosure Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Activity/Section Number of disclosures Total annual Average burden Total hours respondents per respondent disclosures per disclosure ---------------------------------------------------------------------------------------------------------------- Notifying immediate previous 1,200 1 1,200 0.6 (36 minutes) 720 source of the article of food under section 417(d)(6)(B)(i) of the FD&C Act (mandatory reporters only). Notifying immediate subsequent 1,200 1 1,200 0.6 (36 minutes) 720 recipient of the article of food under section 417(d)(6)(B)(ii) of the FD&C Act (mandatory reporters only). Notifying immediate previous 1,200 1 1,200 0.6 (36 minutes) 720 source of the article of food under section 417(d)(7)(C)(i) of the FD&C Act (mandatory reporters only). Notifying immediate subsequent 1,200 1 1,200 0.6 (36 minutes) 720 recipient of the article of food under section 417(d)(7)(C)(ii) of the FD&C Act (mandatory reporters only). --------------------------------------------------------------------------------- Total..................... .............. .............. .............. ................ 2,880 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Third Party Disclosure: We estimate that approximately 1,200 reportable food events with mandatory reporters will occur annually. Based on past FDA experiences, we estimate that we could receive 200 to 1,200 ``reportable'' food [[Page 26492]] reports annually from 200 to 1,200 mandatory and voluntary users of the electronic reporting system. We utilized the upper-bound estimate of 1,200 for these calculations. We estimate that notifying the immediate previous source(s) will take 0.6 hours per reportable food and notifying the immediate subsequent recipient(s) will take 0.6 hours per reportable food. We also estimate that it will take 0.6 hours for the immediate previous source and/or the immediate subsequent recipient to also notify their immediate previous source(s) and/or immediate subsequent recipient(s). The Agency bases its estimate on its experience with mandatory and voluntary reports submitted to FDA. Although it is not mandatory under FDAAA, section 1005 that responsible persons notify the sources and recipients of instances of reportable food, for purposes of the burden estimate we are assuming FDA would exercise its authority and require such notifications in all such instances for mandatory reporters. This notification burden will not affect voluntary reporters of reportable food events. Therefore, we estimate that the total burden of notifying the immediate previous source(s) and immediate subsequent recipient(s) under section 417(d)(6)(B)(i) and (ii), (d)(7)(C)(i) and (ii) of the FD&C Act for 1,200 reportable foods will be 2,880 hours annually (1,200 x 0.6 hours) + (1,200 x 0.6 hours) + (1,200 x 0.6 hours) + (1,200 x 0.6 hours). This annual burden is shown in table 1. Table 2--Estimated Annual Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average burden Activity/Section Number of records per Total annual per Total hours recordkeepers recordkeeper records recordkeeping ---------------------------------------------------------------------------------------------------------------- Maintenance of reportable food 1,200 1 1,200 0.25 (15 300 records under section 417(g) minutes). of the FD&C Act--mandatory reports. Maintenance of reportable food 4 1 4 0.25 (15 1 records under section 417(g) minutes). of the FD&C Act--voluntary reports. --------------------------------------------------------------------------------- Total..................... .............. .............. .............. ................ 301 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Recordkeeping: As noted previously, section 417(g) of the FD&C Act requires that responsible persons maintain records related to reportable foods reports and notifications under section 417 of the FD&C Act for a period of 2 years. Based on past FDA experiences, we estimate that each mandatory report and its associated notifications will require 30 minutes of recordkeeping for the 2-year period, or 15 minutes per record per year. The annual recordkeeping burden for mandatory reportable food reports and their associated notifications is thus estimated to be 300 hours (1,200 x 0.25 hours). We do not expect that records will always be kept in relation to voluntary reportable food reports. Therefore, we estimate that records will be kept for four voluntary reports we expect to receive annually. The recordkeeping burden associated with voluntary reports is thus estimated to be 1 hour annually (4 x 0.25 hours). The estimated total annual recordkeeping burden will be 301 hours annually (1,200 x 0.25 hours) + (4 x 0.25 hours). This annual burden is shown in table 2. Dated: June 1, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-11821 Filed 6-6-17; 8:45 am] BILLING CODE 4164-01-P
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SUPPLEMENTARY INFORMATION: FDA intends to make background ucm111462.htm for procedures on
Agenda: During the morning session, material available to the public no later public conduct during advisory
the committee will discuss biologics than 2 business days before the meeting. committee meetings.
license application (BLA) 761028 for If FDA is unable to post the background Notice of this meeting is given under
ABP 215, a proposed biosimilar to material on its Web site prior to the the Federal Advisory Committee Act (5
Genentech/Roche’s AVASTIN meeting, the background material will U.S.C. app. 2).
(bevacizumab), submitted by Amgen be made publicly available at the
Inc. The proposed indications/uses for Dated: June 1, 2017.
location of the advisory committee
this product are: (1) For the first- or meeting, and the background material Anna K. Abram,
second-line treatment of patients with will be posted on FDA’s Web site after Deputy Commissioner for Policy, Planning,
metastatic carcinoma of the colon or the meeting. Background material is Legislation, and Analysis.
rectum in combination with intravenous available at https://www.fda.gov/ [FR Doc. 2017–11819 Filed 6–6–17; 8:45 am]
5-fluorouracil-based chemotherapy; (2) AdvisoryCommittees/Calendar/ BILLING CODE 4164–01–P
in combination with fluoropyrimidine- default.htm. Scroll down to the
irinotecan- or fluoropyrimidine- appropriate advisory committee meeting
oxaliplatin-based chemotherapy, for the link. DEPARTMENT OF HEALTH AND
second-line treatment of patients with Procedure: Interested persons may HUMAN SERVICES
metastatic colorectal cancer who have present data, information, or views,
progressed on a first-line ABP 215- Food and Drug Administration
orally or in writing, on issues pending
containing regimen; (3) for the first-line before the committee. All electronic and
treatment of unresectable, locally written submissions submitted to the [Docket No. FDA–2009–N–0501]
advanced, recurrent or metastatic non- docket (see the ADDRESSES section) on or
squamous, non-small cell lung cancer in before June 26, 2017, will be provided Agency Information Collection
combination with carboplatin and to the committee. Oral presentations Activities; Proposed Collection;
paclitaxel; (4) for the treatment of from the public will be scheduled Comment Request; Third Party
glioblastoma with progressive disease in between approximately 10:45 a.m. to Disclosure and Recordkeeping
adult patients following prior therapy as 11:15 a.m., and 3:45 p.m. to 4:15 p.m. Requirements for Reportable Food
a single agent; (5) for the treatment of Those individuals interested in making
metastatic renal cell carcinoma in AGENCY: Food and Drug Administration,
formal oral presentations should notify HHS.
combination with interferon alfa; and the contact person and submit a brief
(6) in combination with paclitaxel and statement of the general nature of the ACTION: Notice.
cisplatin or paclitaxel and topotecan for evidence or arguments they wish to
the treatment of persistent, recurrent, or present, the names and addresses of SUMMARY: The Food and Drug
metastatic carcinoma of the cervix. proposed participants, and an Administration (FDA or we) is
During the afternoon session, the indication of the approximate time announcing an opportunity for public
committee will discuss BLA 761074 for requested to make their presentation on comment on the proposed collection of
MYL–1401O, a proposed biosimilar to or before June 16, 2017. Time allotted certain information by the Agency.
Genentech Inc.’s HERCEPTIN for each presentation may be limited. If Under the Paperwork Reduction Act of
(trastuzumab), submitted by Mylan the number of registrants requesting to 1995 (PRA), Federal Agencies are
GmbH. The proposed indications/uses speak is greater than can be reasonably required to publish notice in the
for this product are: (1) For adjuvant accommodated during the scheduled Federal Register concerning each
treatment of HER2 overexpressing node open public hearing session, FDA may proposed collection of information,
positive or node negative (ER/PR conduct a lottery to determine the including each proposed extension of an
negative or with one high risk feature) speakers for the scheduled open public existing collection of information, and
breast cancer; (a) as part of a treatment hearing session. The contact person will to allow 60 days for public comment in
regimen consisting of doxorubicin, notify interested persons regarding their response to the notice. This notice
cyclophosphamide, and either request to speak by June 19, 2017. solicits comments on the information
paclitaxel or docetaxel; (b) with Persons attending FDA’s advisory collection provisions of FDA’s third
docetaxel and carboplatin; or (c) as a committee meetings are advised that the party disclosure and recordkeeping
single agent following multimodality Agency is not responsible for providing requirements for reportable food.
anthracycline based therapy; (2) in access to electrical outlets. DATES: Submit either electronic or
combination with paclitaxel for first- FDA welcomes the attendance of the written comments on the collection of
line treatment of HER2-overexpressing public at its advisory committee information by August 7, 2017.
metastatic breast cancer; (3) as a single meetings and will make every effort to
agent for treatment of HER2- ADDRESSES: You may submit comments
accommodate persons with disabilities.
overexpressing breast cancer in patients as follows. Please note that late,
If you require special accommodations
who have received one or more untimely filed comments will not be
due to a disability, please contact Jay R.
chemotherapy regimens for metastatic considered. Electronic comments must
Fajiculay at least 7 days in advance of
disease; and (4) in combination with be submitted on or before August 7,
the meeting.
cisplatin and capecitabine or 5- FDA is committed to the orderly 2017. The https://www.regulations.gov
fluorouracil, for the treatment of conduct of its advisory committee electronic filing system will accept
comments until midnight Eastern Time
sradovich on DSK3GMQ082PROD with NOTICES
patients with HER2 overexpressing meetings. Please visit our Web site at
metastatic gastric or gastroesophageal https://www.fda.gov/ at the end of August 7, 2017. Comments
junction adenocarcinoma who have not AdvisoryCommittees/ received by mail/hand delivery/courier
received prior treatment for metastatic AboutAdvisoryCommittees/ (for written/paper submissions) will be
disease.1 considered timely if they are
Orphan Drug Designations and Approvals database
postmarked or the delivery service
1 Thisindication is protected by orphan drug at http://www.accessdata.fda.gov/scripts/ acceptance receipt is on or before that
exclusivity expiring on October 20, 2017. See the opdlisting/oopd/index.cfm. date.
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![Federal Register / Vol. 82, No. 108 / Wednesday, June 7, 2017 / Notices 26491
previous source and/or immediate included in the notification provided by As required under section 1005(f) of
subsequent recipient) to notify their the responsible party involved under FDAAA and to assist industry, we have
own immediate previous source(s) and/ section 417(d)(6)(B) or 417(d)(7)(C) of issued the guidance document entitled,
or immediate subsequent recipient(s) of the FD&C Act or required to report ‘‘Questions and Answers Regarding the
a reportable food (section 417(d)(7)(C)(i) under section 417(d)(7)(A) of the FD&C Reportable Food Registry as Established
to (ii) of the FD&C Act). Act; and (10) the unique number by the Food and Drug Administration
Notification to the immediate described in section 417(d)(4) of the Amendments Act of 2007,’’ which is
previous source(s) and immediate FD&C Act (section 417(d)(6)(B)(iii)(I), available at https://www.fda.gov/Food/
subsequent recipient(s) of the article of (d)(7)(C)(iii)(I), and (e) of the FD&C Act). GuidanceRegulation/Guidance
food may be accomplished by electronic We may also require that the DocumentsRegulatoryInformation/
communication methods such as email, notification provides information about ucm180761.htm. The guidance contains
fax, or text messaging or by telegrams, the actions that the recipient of the questions and answers relating to the
mailgrams, or first-class letters. notification will perform and/or any requirements under section 417 of the
Notification may also be accomplished other information we may require FD&C Act, including: (1) How, when
by telephone call or other personal (section 417(d)(6)(B)(iii)(II) and (III), and where to submit reports to FDA; (2)
contacts but we recommend that such (d)(7)(C)(iii)(II) and (III) of the FD&C who is required to submit reports to
notifications also be confirmed by one Act). FDA; (3) what is required to be
of the previous methods and/or Section 417(g) of the FD&C Act submitted to FDA; and (4) what may be
documented in an appropriate manner. requires that responsible persons required when providing notifications
We may require that the notification maintain records related to reportable to other persons in the supply chain of
include any or all of the following data foods for a period of 2 years. an article of food. The guidance also
elements: (1) The date on which the The congressionally identified refers to previously approved
article of food was determined to be a purpose of the Registry is to provide ‘‘a collections of information found in FDA
reportable food; (2) a description of the reliable mechanism to track patterns of regulations. The collections of
article of food including the quantity or adulteration in food [which] would information in questions 20 and 21 of
amount; (3) the extent and nature of the support efforts by the Food and Drug the guidance have been approved under
adulteration; (4) the results of any Administration to target limited OMB control number 0910–0249.
investigation of the cause of the inspection resources to protect the Description of Respondents:
adulteration if it may have originated public health’’ (FDAAA, section Mandatory respondents to this
with the responsible party, if known; (5) 1005(a)(4)). The reporting and collection of information are the
the disposition of the article of food, recordkeeping requirements described owners, operators, or agents in charge of
when known; (6) product information previously are designed to enable FDA a domestic or foreign facility engaged in
typically found on packaging including to quickly identify and track an article manufacturing, processing, packing, or
product codes, use-by dates, and the of food (other than infant formula) for holding food for consumption in the
names of manufacturers, packers, or which there is a reasonable probability United States (‘‘responsible parties’’)
distributors sufficient to identify the that the use of or exposure to such who have information on a reportable
article of food; (7) contact information article of food will cause serious adverse food. Voluntary respondents to this
for the responsible party; (8) contact health consequences or death to humans collection of information are Federal,
information for parties directly linked in or animals. We use the information State, and local public health officials
the supply chain and notified under collected under these regulations to who have information on a reportable
section 417(d)(6)(B) or 417(d)(7)(C) of help ensure that such products are food.
the FD&C Act, as applicable; (9) the quickly and efficiently removed from We estimate the burden of this
information required by FDA to be the market. collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Total
Number of disclosures Average burden per
Activity/Section annual Total hours
respondents per disclosure
disclosures
respondent
Notifying immediate previous source of the arti- 1,200 1 1,200 0.6 (36 minutes) ........... 720
cle of food under section 417(d)(6)(B)(i) of the
FD&C Act (mandatory reporters only).
Notifying immediate subsequent recipient of the 1,200 1 1,200 0.6 (36 minutes) ........... 720
article of food under section 417(d)(6)(B)(ii) of
the FD&C Act (mandatory reporters only).
Notifying immediate previous source of the arti- 1,200 1 1,200 0.6 (36 minutes) ........... 720
cle of food under section 417(d)(7)(C)(i) of the
FD&C Act (mandatory reporters only).
Notifying immediate subsequent recipient of the 1,200 1 1,200 0.6 (36 minutes) ........... 720
article of food under section 417(d)(7)(C)(ii) of
the FD&C Act (mandatory reporters only).
sradovich on DSK3GMQ082PROD with NOTICES
Total ............................................................... ........................ ........................ ........................ ....................................... 2,880
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Third Party Disclosure: We estimate food events with mandatory reporters experiences, we estimate that we could
that approximately 1,200 reportable will occur annually. Based on past FDA receive 200 to 1,200 ‘‘reportable’’ food
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reports annually from 200 to 1,200 immediate previous source(s) and/or burden will not affect voluntary
mandatory and voluntary users of the immediate subsequent recipient(s). The reporters of reportable food events.
electronic reporting system. We utilized Agency bases its estimate on its Therefore, we estimate that the total
the upper-bound estimate of 1,200 for experience with mandatory and burden of notifying the immediate
these calculations. voluntary reports submitted to FDA. previous source(s) and immediate
We estimate that notifying the Although it is not mandatory under subsequent recipient(s) under section
immediate previous source(s) will take FDAAA, section 1005 that responsible 417(d)(6)(B)(i) and (ii), (d)(7)(C)(i) and
0.6 hours per reportable food and persons notify the sources and (ii) of the FD&C Act for 1,200 reportable
notifying the immediate subsequent recipients of instances of reportable
foods will be 2,880 hours annually
recipient(s) will take 0.6 hours per food, for purposes of the burden
(1,200 × 0.6 hours) + (1,200 × 0.6 hours)
reportable food. We also estimate that it estimate we are assuming FDA would
will take 0.6 hours for the immediate exercise its authority and require such + (1,200 × 0.6 hours) + (1,200 × 0.6
previous source and/or the immediate notifications in all such instances for hours). This annual burden is shown in
subsequent recipient to also notify their mandatory reporters. This notification table 1.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
Activity/Section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
Maintenance of reportable food records under 1,200 1 1,200 0.25 (15 minutes) ......... 300
section 417(g) of the FD&C Act—mandatory
reports.
Maintenance of reportable food records under 4 1 4 0.25 (15 minutes) ......... 1
section 417(g) of the FD&C Act—voluntary re-
ports.
Total ............................................................... ........................ ........................ ........................ ....................................... 301
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Recordkeeping: As noted previously, DEPARTMENT OF HEALTH AND AdvisoryCommittees/
section 417(g) of the FD&C Act requires HUMAN SERVICES AboutAdvisoryCommittees/
that responsible persons maintain ucm408555.htm.
records related to reportable foods Food and Drug Administration FDA is establishing a docket for
reports and notifications under section [Docket No. FDA–2017–N–2734] public comment on this meeting. The
417 of the FD&C Act for a period of 2 docket number is FDA–2017–N–2734.
years. Based on past FDA experiences, Oncologic Drugs Advisory Committee; The docket will close on July 10, 2017.
we estimate that each mandatory report Notice of Meeting; Establishment of a Submit either electronic or written
and its associated notifications will Public Docket; Request for Comments comments on this public meeting by
require 30 minutes of recordkeeping for July 10, 2017. Late, untimely filed
AGENCY: Food and Drug Administration, comments will not be considered.
the 2-year period, or 15 minutes per HHS.
record per year. The annual Electronic comments must be submitted
recordkeeping burden for mandatory ACTION: Notice; establishment of a on or before July 10, 2017. The https://
public docket; request for comments. www.regulations.gov electronic filing
reportable food reports and their
associated notifications is thus system will accept comments until
SUMMARY: The Food and Drug midnight eastern time, July 10, 2017.
estimated to be 300 hours (1,200 × 0.25 Administration (FDA or Agency)
hours). Comments received by mail/hand
announces a forthcoming public delivery/courier for written/paper
We do not expect that records will advisory committee meeting of the submissions will be considered timely if
always be kept in relation to voluntary Oncologic Drugs Advisory Committee. they are postmarked or the delivery
reportable food reports. Therefore, we The general function of the committee is service acceptance receipt is on or
estimate that records will be kept for to provide advice and recommendations before that date.
four voluntary reports we expect to to the Agency on FDA’s regulatory Comments received on or before June
receive annually. The recordkeeping issues. The meeting will be open to the 26, 2017, will be provided to the
burden associated with voluntary public. FDA is establishing a docket for committee. Comments received after
reports is thus estimated to be 1 hour public comment on this document. that date will be taken into
annually (4 × 0.25 hours). The estimated DATES: The public meeting will be held consideration by the Agency.
total annual recordkeeping burden will on July 12, 2017, from 8 a.m. to 5 p.m. You may submit comments as
be 301 hours annually (1,200 × 0.25 ADDRESSES: FDA White Oak Campus, follows:
hours) + (4 × 0.25 hours). This annual 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room Electronic Submissions
sradovich on DSK3GMQ082PROD with NOTICES
burden is shown in table 2.
Dated: June 1, 2017.
(Rm. 1503), Silver Spring, MD 20993– Submit electronic comments in the
0002. Answers to commonly asked following way:
Anna K. Abram, questions including information • Federal eRulemaking Portal:
Deputy Commissioner for Policy, Planning, regarding special accommodations due https://www.regulations.gov. Follow the
Legislation, and Analysis. to a disability, visitor parking, and instructions for submitting comments.
[FR Doc. 2017–11821 Filed 6–6–17; 8:45 am] transportation may be accessed at: Comments submitted electronically,
BILLING CODE 4164–01–P https://www.fda.gov/ including attachments, to
VerDate Sep<11>2014 20:16 Jun 06, 2017 Jkt 241001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\07JNN1.SGM 07JNN1](https://thefederalregister.org/doc/82_FR_26597/page/4.svg)
Document Created: 2017-06-07 02:00:59
Document Modified: 2017-06-07 02:00:59
| 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 7, 2017. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 82 FR 26489 |
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