83 FR 46499 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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 178 (September 13, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 178 (September 13, 2018)
| Page Range | 46499-46500 | |
| FR Document | 2018-19911 |
[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)] [Notices] [Pages 46499-46500] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19911] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0920] Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by October 15, 2018. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0751. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A- 12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. [[Page 46500]] Current Good Manufacturing Practice, 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 in the tables below. In the Federal Register of June 1, 2018 (83 FR 25466), FDA published a 60-day notice requesting public comment on the proposed collection of information. One comment was received stating that our estimate of burden associated with creating a food safety plan was too low and suggested a much higher figure. We appreciate this comment. However, because the annual burden is based on an industry average and because we continue to evaluate this relatively new collection, we are not adjusting our current estimate. At the same time, we continue to invite comment so that we might better refine our estimates for all elements of the collection. Our estimate of the burden for the information collection is as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Number of responses Total 21 CFR section respondents per annual Average burden per response Total hours 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. Table 2--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Total 21 CFR section Number of records per annual Average burden per recordkeeping Total hours recordkeepers recordkeeper records -------------------------------------------------------------------------------------------------------------------------------------------------------- 117.126(c) and 117.170(d); food safety plan and 46,685 1 46,685 110.......................................... 5,135,350 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 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 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 Number of disclosures Total Average 21 CFR section respondents per annual burden per Total hours respondent disclosures disclosure ---------------------------------------------------------------------------------------------------------------- 117.201(e); disclosure of food manufacturing 37,134 1 37,134 0.25 (15 9,284 facility address.............................. minutes) ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. As stated previously, we retain the currently approved burden for the information collection. 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: September 7, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-19911 Filed 9-12-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices 46499
must send a letter stating that interest to small business tobacco manufacturing This notice is issued under the
FDA by October 15, 2018, (see sections industry, which may be filled on a Federal Advisory Committee Act (5
I and II of this document for further rotating, sequential basis by U.S.C. app. 2) and 21 CFR part 14,
details). Concurrently, nomination representatives of different small relating to advisory committees.
materials for prospective candidates business tobacco manufacturers based Dated: September 7, 2018.
should be sent to FDA by October 15, on areas of expertise relevant to the
Leslie Kux,
2018. topics being considered by the Advisory
Committee. Associate Commissioner for Policy.
ADDRESSES: All statements of interest
With this notice, nominations are [FR Doc. 2018–19922 Filed 9–12–18; 8:45 am]
from small business tobacco
manufacturing industry organizations sought for a pool of individuals, with BILLING CODE 4164–01–P
interested in participating in the varying areas of expertise, to represent
selection process of nonvoting industry the interests of the small business
tobacco manufacturing industry on a DEPARTMENT OF HEALTH AND
representative nominations should be
rotating, sequential basis. HUMAN SERVICES
sent to Caryn Cohen (see FOR FURTHER
INFORMATION CONTACT). All nominations II. Selection Procedure Food and Drug Administration
for nonvoting industry representatives
may be submitted electronically by Any industry organization interested
in participating in the selection of an [Docket No. FDA–2011–N–0920]
accessing the FDA Advisory Committee
appropriate nonvoting member to
Membership Nomination Portal at: Agency Information Collection
represent industry interests should send
https://www.accessdata.fda.gov/scripts/ Activities; Submission for Office of
a letter stating that interest to the FDA
FACTRSPortal/FACTRS/index.cfm or by Management and Budget Review;
contact (see FOR FURTHER INFORMATION
mail to Advisory Committee Oversight Comment Request; Current Good
CONTACT) within 30 days of publication
and Management Staff, Food and Drug Manufacturing Practice, Hazard
of this document (see DATES). Within the
Administration, 10903 New Hampshire Analysis, and Risk-Based Preventive
subsequent 30 days, FDA will send a
Ave., Bldg. 32, Rm. 5103, Silver Spring, Controls for Human Food
letter to each organization that has
MD 20993–0002. Information about
expressed an interest, attaching a
becoming a member of an FDA advisory AGENCY: Food and Drug Administration,
complete list of all such organizations;
committee can also be obtained by and a list of all nominees along with HHS.
visiting FDA’s website at: https:// their current resumes. The letter will
www.fda.gov/AdvisoryCommittees/ ACTION: Notice.
also state that it is the responsibility of
default.htm. the interested organizations to confer
FOR FURTHER INFORMATION CONTACT:
SUMMARY: The Food and Drug
with one another and to select a Administration (FDA) is announcing
Caryn Cohen, Office of Science, Center candidate, within 60 days after the
for Tobacco Products, Food and Drug that a proposed collection of
receipt of the FDA letter, to serve as the information has been submitted to the
Administration, Center for Tobacco nonvoting member to represent industry
Products Document Control Center, Office of Management and Budget
interests for the committee. The (OMB) for review and clearance under
10903 New Hampshire Ave., Bldg. 71, interested organizations are not bound
Rm. G335, Silver Spring, MD 20993– the Paperwork Reduction Act of 1995.
by the list of nominees in selecting a
0002, 1–877–287–1373 (choose Option candidate. However, if no individual is DATES: Fax written comments on the
5), TPSAC@fda.hhs.gov. selected within 60 days, the collection of information by October 15,
SUPPLEMENTARY INFORMATION: The Commissioner will select the nonvoting 2018.
Agency intends to add a nonvoting member to represent industry interests.
ADDRESSES: To ensure that comments on
industry representative to represent the
III. Application Procedure the information collection are received,
interests of the small business tobacco
Individuals may self-nominate and/or OMB recommends that written
manufacturing industry to the following
an organization may nominate one or comments be faxed to the Office of
advisory committee:
more individuals to serve as a nonvoting Information and Regulatory Affairs,
I. Tobacco Products Scientific Advisory industry representative. Contact OMB, Attn: FDA Desk Officer, Fax: 202–
Committee information, a current curriculum vitae, 395–7285, or emailed to oira_
The Tobacco Products Scientific and the name of the committee of submission@omb.eop.gov. All
Advisory Committee (the Committee) interest should be sent to the FDA comments should be identified with the
advises the Commissioner of Food and Advisory Committee Membership OMB control number 0910–0751. Also
Drugs (the Commissioner) or designee in Nomination Portal (see ADDRESSES) include the FDA docket number found
discharging responsibilities related to within 30 days of publication of this in brackets in the heading of this
the regulation of tobacco products. The document (see DATES). FDA will forward document.
Committee reviews and evaluates safety, all nominations to the organizations FOR FURTHER INFORMATION CONTACT:
dependence, and health issues relating expressing interest in participating in JonnaLynn Capezzuto, Office of
to tobacco products and provides the selection process for the committee. Operations, Food and Drug
appropriate advice, information, and (Persons who nominate themselves as Administration, Three White Flint
recommendations to the Commissioner. nonvoting industry representatives will North, 10A–12M, 11601 Landsdown St.,
The Committee includes three not participate in the selection process).
daltland on DSKBBV9HB2PROD with NOTICES
North Bethesda, MD 20852, 301–796–
nonvoting members who represent FDA seeks to include the views of
3794, PRAStaff@fda.hhs.gov.
industry interests. These members women, and men, members of all racial
include one representative of the and ethnic groups and individuals with SUPPLEMENTARY INFORMATION: In
interests of the tobacco manufacturing and without disabilities on its advisory compliance with 44 U.S.C. 3507, FDA
industry; one representative of the committees and, therefore encourages has submitted the following proposed
interests of tobacco growers; and one nominations of appropriately qualified collection of information to OMB for
representative of the interests of the candidates from these groups. review and clearance.
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![46500 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices
Current Good Manufacturing Practice, in food production. Specifically, section information collection, we retain the
Hazard Analysis, and Risk-Based 418 of the FD&C Act (21 U.S.C. 350g) currently approved figures as shown in
Preventive Controls for Human Food— sets forth requirements for hazard the tables below.
21 CFR Part 117 analysis and risk-based preventive In the Federal Register of June 1, 2018
OMB Control Number 0910–0751— controls for facilities that produce food (83 FR 25466), FDA published a 60-day
Extension for human consumption. To implement notice requesting public comment on
these provisions, regulations were the proposed collection of information.
This information collection supports codified under 21 CFR part 117—
FDA regulations. As amended by the One comment was received stating that
Current Good Manufacturing Practice, our estimate of burden associated with
FDA Food Safety Modernization Act
Hazard Analysis, and Risk-Based creating a food safety plan was too low
(FSMA) (Pub. L. 111–353), the Federal
Food, Drug, and Cosmetic Act (FD&C Preventive Controls for Human Food. and suggested a much higher figure. We
Act) enables the Agency to better protect The regulations establish requirements appreciate this comment. However,
the public health by helping to ensure for a written food safety plan; hazard because the annual burden is based on
the safety and security of the food analysis preventive controls; an industry average and because we
supply. It enables FDA to focus more on monitoring; corrective actions and continue to evaluate this relatively new
preventing food safety problems rather corrections; verification; supply-chain collection, we are not adjusting our
than relying primarily on reacting to program; recall plan; and associated current estimate. At the same time, we
problems after they occur. FSMA records, and became effective November continue to invite comment so that we
recognizes the important role industry 16, 2015. Currently, we continue to might better refine our estimates for all
plays in ensuring the safety of the food evaluate burden associated with the elements of the collection.
supply, including the adoption of information collection requirements; Our estimate of the burden for the
modern systems of preventive controls however, for purposes of extending the information collection is as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of responses Total annual Average
21 CFR section Total hours
respondents per responses burden per response
respondent
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.
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 reanalysis ...................... 46,685 1 46,685 110 .................................. 5,135,350
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 records .............................. 16,285 2 32,570 1 ...................................... 32,570
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 qualified individual ..... 46,685 1 46,685 0.25 (15 minutes) ........... 11,671
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 disclosures Total annual
21 CFR section burden per Total hours
respondents per disclosures disclosure
respondent
117.201(e); disclosure of food manufacturing facility address ................................................. 37,134 1 37,134 0.25 (15 9,284
minutes)
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
As stated previously, we retain the Using Agency data, we estimated the Dated: September 7, 2018.
currently approved burden for the number of food facilities that we believe Leslie Kux,
information collection. These figures are are subject to the regulations. We base Associate Commissioner for Policy.
based on our regulatory impact analysis our estimate of the time necessary for [FR Doc. 2018–19911 Filed 9–12–18; 8:45 am]
daltland on DSKBBV9HB2PROD with NOTICES
in support of the final rule on the individual reporting, recordkeeping, BILLING CODE 4164–01–P
preventive controls for human food, and third-party disclosure activities on
which published in the Federal Register our experience with similar information
of September 17, 2015 (80 FR 55908). collections.
VerDate Sep<11>2014 19:20 Sep 12, 2018 Jkt 244001 PO 00000 Frm 00025 Fmt 4703 Sfmt 9990 E:\FR\FM\13SEN1.SGM 13SEN1](https://thefederalregister.org/doc/83_FR_46677/page/2.svg)
Document Created: 2018-09-13 01:01:13
Document Modified: 2018-09-13 01:01:13
| 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 | Fax written comments on the collection of information by October 15, 2018. | |
| Contact | JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A- 12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, [email protected] | |
| FR Citation | 83 FR 46499 |
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