83 FR 25466 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 106 (June 1, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 106 (June 1, 2018)
| Page Range | 25466-25468 | |
| FR Document | 2018-11801 |
[Federal Register Volume 83, Number 106 (Friday, June 1, 2018)] [Notices] [Pages 25466-25468] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-11801] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0920] Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food 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 requirements associated with current good manufacturing practice, hazard analysis, and risk-based preventive controls for human food. DATES: Submit either electronic or written comments on the collection of information by July 31, 2018. 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 July 31, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 31, 2018. 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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. [[Page 25467]] For written/paper comments submitted to the Dockets Management Staff, 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-0920 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.'' 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 Dockets Management Staff 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 Dockets Management Staff. 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, PRAStaff@fda.hhs.gov. 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. Current Good Manufacturing Practice and Hazard Analysis, and Risk-Based Preventive Controls for Human Food--21 CFR Part 117 OMB Control Number 0910-0751--Extension This information collection supports FDA regulations. As amended by the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), the Federal Food, Drug, and Cosmetic Act (FD&C Act) enables the Agency to better protect the public health by helping to ensure the safety and security of the food supply. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. FSMA recognizes the important role industry plays in ensuring the safety of the food supply, including the adoption of modern systems of preventive controls in food production. Specifically, section 418 of the FD&C Act (21 U.S.C. 350g) sets forth requirements for hazard analysis and risk-based preventive controls for facilities that produce food for human consumption. To implement these provisions, regulations were codified under 21 CFR part 117--Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. The regulations establish requirements for a written food safety plan; hazard analysis preventive controls; monitoring; corrective actions and corrections; verification; supply- chain program; recall plan; and associated records, and became effective November 16, 2015. Currently, we continue to evaluate burden associated with the information collection requirements; however, for purposes of extending the information collection we retain the currently approved figures as shown below. Our estimate of the burden for the information collection is as follows: Table 1--Estimated Annual Reporting Burden 1 -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR section Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- 117.201(e); qualified facility............... 37,134 0.5 18,567 0.5 (30 minutes)........................ 9,284 -------------------------------------------------------------------------------------------------------------------------------------------------------- 1 There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 25468]] Table 2--Estimated Annual Recordkeeping Burden 1 -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours recordkeepers recordkeeper records -------------------------------------------------------------------------------------------------------------------------------------------------------- 117.126(c) and 117.170(d); food safety plan 46,685 1 46,685 110..................................... 5,135,350 and reanalysis. 117.136; assurance records................... 16,285 1 16,285 0.25 (15 minutes)....................... 4,071 117.145(c); monitoring records............... 8,143 730 5,944,390 0.05 (3 minutes)........................ 297,220 117.150(d); corrective actions and 16,285 2 32,570 1....................................... 32,570 corrections records. 117.155(b); verification records............. 8,143 244 1,986,892 0.05 (3 minutes)........................ 99,345 117.160; validation records.................. 3,677 6 22,062 0.25 (15 minutes)....................... 5,515 117.475(c)(7)-(9); supplier records.......... 16,285 10 162,850 4....................................... 651,400 117.180(d); training records for preventive 46,685 1 46,685 0.25 (15 minutes)....................... 11,671 controls qualified individual. ---------------------------------------------------------------------------------------------------------- Total.................................... .............. ............... .............. ........................................ 6,237,142 -------------------------------------------------------------------------------------------------------------------------------------------------------- 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Table 3--Estimated Annual Third-Party Disclosure Burden 1 -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR section Number of disclosures per Total annual Average burden per disclosure Total hours respondents respondent disclosures -------------------------------------------------------------------------------------------------------------------------------------------------------- 117.201(e); disclosure of food manufacturing 37,134 1 37,134 0.25 (15 minutes)....................... 9,284 facility address. -------------------------------------------------------------------------------------------------------------------------------------------------------- 1 There are no capital costs or operating and maintenance costs associated with this collection of information. These figures are based on our regulatory impact analysis in support of the final rule on preventive controls for human food, which published in the Federal Register of September 17, 2015 (80 FR 55908). Using Agency data, we estimated the number of food facilities that we believe are subject to the regulations. We base our estimate of the time necessary for the individual reporting, recordkeeping, and third- party disclosure activities on our experience with similar information collections. Dated: May 25, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-11801 Filed 5-31-18; 8:45 am] BILLING CODE 4164-01-P
![25466 Federal Register / Vol. 83, No. 106 / Friday, June 1, 2018 / Notices
3600, Elaine.Lippmann@fda.hhs.gov; or II. Paperwork Reduction Act of 1995 including each proposed extension of an
Stephen Ripley, Center for Biologics This draft guidance refers to existing collection of information, and
Evaluation and Research, Food and collections of information that are to allow 60 days for public comment in
Drug Administration, 10903 New subject to review by the Office of response to the notice. This notice
Hampshire Ave., Bldg. 71, Rm. 7301, Management and Budget (OMB) under solicits comments on the information
Silver Spring, MD 20993–0002, 240– the Paperwork Reduction Act of 1995 collection requirements associated with
402–7911. (PRA) (44 U.S.C. 3501–3520). The current good manufacturing practice,
SUPPLEMENTARY INFORMATION: preparation and submission of waiver hazard analysis, and risk-based
requests (as described in 21 CFR 314.90 preventive controls for human food.
I. Background
for new drug application applicants and DATES: Submit either electronic or
FDA is announcing the availability of 314.99(b) for ANDA applicants) has written comments on the collection of
a draft guidance for industry entitled been approved under OMB control information by July 31, 2018.
‘‘Waivers of the Single, Shared System number 0910–0001. In accordance with ADDRESSES: You may submit comments
REMS Requirement.’’ This guidance the PRA, before publication of the final as follows. Please note that late,
describes how the Agency intends to guidance document, FDA intends to untimely filed comments will not be
consider granting a waiver of the solicit public comment and obtain OMB considered. Electronic comments must
requirement in section 505–1(i) of the approval for any information collections be submitted on or before July 31, 2018.
FD&C Act (21 U.S.C. 355–1(i)) that the recommended in this guidance that are The https://www.regulations.gov
applicant for an ANDA and its RLD use new or that would represent material electronic filing system will accept
a SSS for a required REMS with ETASU. modifications to previously approved comments until midnight Eastern Time
Section 505–l(i)(l)(B) of the FD&C Act collections of information found in FDA at the end of July 31, 2018. Comments
requires that a holder of an ANDA regulations. received by mail/hand delivery/courier
under section 505(j) use a ‘‘single, (for written/paper submissions) will be
shared system’’ with the RLD for any III. Electronic Access
considered timely if they are
ETASU, unless FDA waives this Persons with access to the internet postmarked or the delivery service
requirement. The statute permits a may obtain the draft guidance at either acceptance receipt is on or before that
waiver of the SSS requirement if FDA https://www.fda.gov/Drugs/ date.
finds that (1) ‘‘the burden of creating a GuidanceCompliance
[SSS] outweighs the benefit of a single, RegulatoryInformation/Guidances/ Electronic Submissions
system, taking into consideration the default.htm, https://www.fda.gov/ Submit electronic comments in the
impact on health care providers, BiologicsBloodVaccines/Guidance following way:
patients, the applicant for the [ANDA], ComplianceRegulatoryInformation/ • Federal eRulemaking Portal:
and the holder of the reference drug Guidances/default.htm, or https:// https://www.regulations.gov. Follow the
product,’’ or (2) an aspect of the ETASU www.regulations.gov. instructions for submitting comments.
for the applicable listed drug is claimed Dated: May 24, 2018. Comments submitted electronically,
by an unexpired patent or trade secret including attachments, to https://
Leslie Kux,
and the ANDA applicant certifies that it www.regulations.gov will be posted to
Associate Commissioner for Policy.
sought a license for use of the aspect, the docket unchanged. Because your
but was unable to obtain one. If a waiver [FR Doc. 2018–11784 Filed 5–31–18; 8:45 am]
comment will be made public, you are
of the SSS requirement is granted, the BILLING CODE 4164–01–P
solely responsible for ensuring that your
ANDA may use ‘‘a different, comparable comment does not include any
aspect of the [ETASU],’’ instead of confidential information that you or a
participating in a SSS with the RLD. DEPARTMENT OF HEALTH AND
third party may not wish to be posted,
This guidance is intended to explain HUMAN SERVICES
such as medical information, your or
the factors FDA will consider in Food and Drug Administration anyone else’s Social Security number, or
evaluating a request for waiver of the confidential business information, such
SSS requirement and provide [Docket No. FDA–2011–N–0920] as a manufacturing process. Please note
recommendations to ANDA applicants that if you include your name, contact
regarding the submission and content of Agency Information Collection
information, or other information that
waiver requests. The guidance also Activities; Proposed Collection;
identifies you in the body of your
addresses FDA’s interpretation of what Comment Request; Current Good
comments, that information will be
constitutes a different, comparable Manufacturing Practice, Hazard
posted on https://www.regulations.gov.
Analysis, and Risk-Based Preventive
aspect of the ETASU as described in • If you want to submit a comment
section 505–1(i)(1)(B). Controls for Human Food
with confidential information that you
This draft guidance is being issued AGENCY: Food and Drug Administration, do not wish to be made available to the
consistent with FDA’s good guidance HHS. public, submit the comment as a
practices regulation (21 CFR 10.115). ACTION: Notice. written/paper submission and in the
The draft guidance, when finalized, will manner detailed (see ‘‘Written/Paper
represent the current thinking of FDA SUMMARY: The Food and Drug Submissions’’ and ‘‘Instructions’’).
on ‘‘Waivers of the Single, Shared Administration (FDA or Agency) is
System REMS Requirement.’’ It does not announcing an opportunity for public Written/Paper Submissions
daltland on DSKBBV9HB2PROD with NOTICES
establish any rights for any person and comment on the proposed collection of Submit written/paper submissions as
is not binding on FDA or the public. certain information by the Agency. follows:
You can use an alternative approach if Under the Paperwork Reduction Act of • Mail/Hand delivery/Courier (for
it satisfies the requirements of the 1995 (PRA), Federal Agencies are written/paper submissions): Dockets
applicable statutes and regulations. This required to publish notice in the Management Staff (HFA–305), Food and
guidance is not subject to Executive Federal Register concerning each Drug Administration, 5630 Fishers
Order 12866. proposed collection of information, Lane, Rm. 1061, Rockville, MD 20852.
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![25468 Federal Register / Vol. 83, No. 106 / Friday, June 1, 2018 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
21 CFR section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
117.126(c) and 117.170(d); food safety plan and re- 46,685 1 46,685 110 ........................ 5,135,350
analysis.
117.136; assurance records ....................................... 16,285 1 16,285 0.25 (15 minutes) .. 4,071
117.145(c); monitoring records .................................. 8,143 730 5,944,390 0.05 (3 minutes) .... 297,220
117.150(d); corrective actions and corrections 16,285 2 32,570 1 ............................ 32,570
records.
117.155(b); verification records .................................. 8,143 244 1,986,892 0.05 (3 minutes) .... 99,345
117.160; validation records ........................................ 3,677 6 22,062 0.25 (15 minutes) .. 5,515
117.475(c)(7)-(9); supplier records ............................ 16,285 10 162,850 4 ............................ 651,400
117.180(d); training records for preventive controls 46,685 1 46,685 0.25 (15 minutes) .. 11,671
qualified individual.
Total .................................................................... ........................ .......................... ........................ ............................... 6,237,142
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of Total annual
21 CFR section disclosures burden per Total hours
respondents disclosures
per respondent disclosure
117.201(e); disclosure of food manufacturing facility 37,134 1 37,134 0.25 (15 minutes) .. 9,284
address.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
These figures are based on our announcing the availability of a draft such as medical information, your or
regulatory impact analysis in support of guidance for industry entitled anyone else’s Social Security number, or
the final rule on preventive controls for ‘‘Development of a Shared System confidential business information, such
human food, which published in the REMS.’’ This draft guidance provides as a manufacturing process. Please note
Federal Register of September 17, 2015 recommendations on the development that if you include your name, contact
(80 FR 55908). Using Agency data, we of a shared system risk evaluation and information, or other information that
estimated the number of food facilities mitigation strategy (REMS) for multiple identifies you in the body of your
that we believe are subject to the prescription drug (including biological) comments, that information will be
regulations. We base our estimate of the products. This guidance describes some posted on https://www.regulations.gov.
time necessary for the individual of the possible benefits of a shared • If you want to submit a comment
reporting, recordkeeping, and third- system REMS, and provides general with confidential information that you
party disclosure activities on our principles and recommendations to do not wish to be made available to the
experience with similar information assist industry with the development of public, submit the comment as a
collections. these programs. written/paper submission and in the
DATES: Submit either electronic or
manner detailed (see ‘‘Written/Paper
Dated: May 25, 2018.
written comments on the draft guidance Submissions’’ and ‘‘Instructions’’).
Leslie Kux,
Associate Commissioner for Policy. by July 31, 2018 to ensure that the Written/Paper Submissions
[FR Doc. 2018–11801 Filed 5–31–18; 8:45 am]
Agency considers your comment on this Submit written/paper submissions as
draft guidance before it begins work on follows:
BILLING CODE 4164–01–P
the final version of the guidance. • Mail/Hand delivery/Courier (for
ADDRESSES: You may submit comments written/paper submissions): Dockets
DEPARTMENT OF HEALTH AND on any guidance at any time as follows: Management Staff (HFA–305), Food and
HUMAN SERVICES Electronic Submissions Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Food and Drug Administration Submit electronic comments in the • For written/paper comments
following way: submitted to the Dockets Management
[Docket No. FDA–2018–D–1041] • Federal eRulemaking Portal: Staff, FDA will post your comment, as
https://www.regulations.gov. Follow the well as any attachments, except for
Development of a Shared System Risk
instructions for submitting comments. information submitted, marked and
Evaluation and Mitigation Strategy;
Comments submitted electronically, identified, as confidential, if submitted
Draft Guidance for Industry;
including attachments, to https:// as detailed in ‘‘Instructions.’’
daltland on DSKBBV9HB2PROD with NOTICES
Availability
www.regulations.gov will be posted to Instructions: All submissions received
AGENCY: Food and Drug Administration, the docket unchanged. Because your must include the Docket No. FDA–
HHS. comment will be made public, you are 2018–D–1041 for ‘‘Development of a
ACTION: Notice of availability. solely responsible for ensuring that your Shared System REMS; Draft Guidance
comment does not include any for Industry; Availability.’’ Received
SUMMARY: The Food and Drug confidential information that you or a comments will be placed in the docket
Administration (FDA or Agency) is third party may not wish to be posted, and, except for those submitted as
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Document Created: 2018-06-01 01:29:38
Document Modified: 2018-06-01 01:29:38
| 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 July 31, 2018. | |
| Contact | Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected] | |
| FR Citation | 83 FR 25466 |
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