83 FR 27330 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Qualified Facility Attestation
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 113 (June 12, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 113 (June 12, 2018)
| Page Range | 27330-27332 | |
| FR Document | 2018-12615 |
[Federal Register Volume 83, Number 113 (Tuesday, June 12, 2018)] [Notices] [Pages 27330-27332] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12615] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-1164] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Qualified Facility Attestation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) 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 June 12, 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--NEW and title ``Qualified Facility Attestation.'' Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three [[Page 27331]] White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [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. Qualified Facility Attestation OMB Control Number 0910--NEW The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) enables FDA to better protect 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. Section 103 of FSMA amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding section 418 (21 U.S.C. 350g) with requirements for hazard analysis and risk-based preventive controls for facilities that produce food for humans or animals. We have established regulations to implement these requirements primarily within subparts C and G, with associated requirements in subparts A, D, E, and F, of the rule entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food'' (Preventive Controls for Human Food Rule) (21 CFR part 117) and primarily within subparts C and E, with associated requirements in subparts A, D, and F, of the rule entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals'' (Preventive Controls for Animal Food Rule) (21 CFR part 507). A business that meets the definition of a ``qualified facility'' (see 21 CFR 117.3 or 21 CFR 507.3) is subject to modified requirements in Sec. 117.201 of the Preventive Controls for Human Food Rule or in Sec. 507.7 of the Preventive Controls for Animal Food Rule. These modified requirements require the business to submit a form to FDA, attesting to its status as a qualified facility. Section 418(l)(2)(B)(ii) of the FD&C Act directs FDA to issue guidance on the documents a business is required to submit to FDA to show its status as a qualified facility. FDA issued a draft guidance for industry entitled, ``Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food): Guidance for Industry.'' This draft guidance explains FDA's current thinking on how to determine whether a business is a qualified facility, and describes FDA procedures regarding the submission of attestations as established under both the Preventive Controls for Human Food Rule and the Preventive Controls for Animal Food Rule. FDA has developed proposed Forms FDA 3942a and FDA 3942b for use by a business in reporting its status as a ``qualified facility'' under the applicable regulations. Description of Respondents: Respondents to the collection of information are owners, operators, or agents in charge of domestic or foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States, are required to register with FDA, and attest that a facility is a ``qualified facility'' under applicable FDA regulations. In the Federal Register of May 16, 2016 (81 FR 30219), FDA published a 60-day notice requesting public comment on the proposed collection of information. One individual submitted several comments. (Comment 1) One comment suggests that Forms FDA 3942a and FDA 3942b could be organized differently to help respondents. Specifically, the suggestion offered that the forms themselves should follow the submission type order as provided in section 2 of both forms so that the ``Status Change'' section is at the end of each form. (Response) FDA agrees and will reorganize Forms FDA 3942a and FDA 3942b so that the ``Status Change'' section will now be section 6. (Comment 2) One comment recommends changing the term ``Biennial Submission'' to ``Biennial (Renewal) Submission'' or in some way to indicate that biennial submission happens in the years after the ``Initial Submission.'' (Response) FDA agrees and will change ``Biennial Submission'' to ``Biennial (Renewal) Submission'' for both forms. (Comment 3) One comment suggests that any revisions applied to either the forms or instructions should be consistent between all the documents. (Response) FDA agrees and will make sure that revisions to the forms and instructions are consistent. (Comment 4) One comment suggests that, for clarity, the instructions direct respondents to the guidance for additional reference. (Response) FDA agrees and will include a reference to the guidance document in each section of the instruction document. (Comment 5) One comment suggests that, for clarity, Question II.A.1 (and III.A. 1) of the guidance should advise respondents that the definition for ``very small business'' is forthcoming in the next question. (Response) FDA agrees, and for clarity, will revise the final guidance to indicate that the definition for ``very small business'' is provided in the next question in the guidance. (Comment 6) One comment suggests that Question II.A. 2 (and III.A.2) in the guidance should provide clarity as to the two options for meeting the qualified facility definition. (Response) FDA agrees and will revise the final guidance to provide clarity as to the two options for meeting the qualified facility definition. (Comment 7) One comment suggests that the guidance should provide more details about what other documentation FDA would accept as to support the first and second attestation options. (Response) FDA agrees and will provide more details about the types of documentation FDA would accept to support the first attestation option. FDA will also include a list of examples of documents that FDA would accept to support the second attestation option consistent with the preamble discussions for Sec. Sec. 117.201(a)(2)(ii) and 507.7(a)(2)(ii). (Comment 8) One comment suggests that Question II.C.6 (and III.C.6) of the guidance oversimplifies the definition of farm and should clarify that farms that satisfy FDA's definition of ``farm'' need not submit Form FDA 3942a. (Response) FDA agrees and will revise our responses to clarify that farms that satisfy FDA's definition of ``farm'' need not submit Form FDA 3942a or Form FDA 3942b. (Comment 9) One comment suggests that Question II.C.7 (and III.C 7) of the guidance related to farm mixed-type facilities is missing certain information to assist farm mixed-type facilities to determine their level of coverage and compliance under regulations. (Response) FDA agrees and will revise our response to provide greater clarity for farm mixed-type facilities to determine their level of coverage and compliance under the regulations. FDA estimates the burden of this collection of information as follows: [[Page 27332]] Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Guidance section FDA form Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- Section II; Human Food.................... 3942a 37,134 .5 18,567 .5 (30 minutes)............. 9,284 Section III; Animal Food.................. 3942b 1,120 .5 560 .5 (30 minutes)............. 280 ------------------------------------------------------------------------------------------------------------- Total................................. .............. .............. .............. .............. ............................ 9,564 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Consistent with the estimates found in our Preventive Controls for Human Food Rule, we estimate that approximately 37,134 human food facilities will each spend approximately 30 minutes (0.5 hour) reporting their status as a qualified facility to FDA every 2 years. Thus, dividing this figure by two to determine the annual burden, we estimate there will be 18,567 responses and 9,284 burden hours associated with this information collection element. Similarly, and consistent with the estimates found in our Preventive Controls for Animal Food Rule, we estimate that approximately 1,120 animal food facilities will each spend approximately 30 minutes (0.5 hour) reporting their status as a qualified facility to FDA every 2 years. Thus, dividing this figure by two to determine the annual burden, we estimate there will be 560 responses and 280 burden hours associated with this information collection element. The draft guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in 21 CFR part 117 have been approved under OMB control number 0910- 0751. The collections of information in 21 CFR part 507 have been approved under OMB control number 0910-0789. Dated: June 7, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-12615 Filed 6-11-18; 8:45 am] BILLING CODE 4164-01-P
![27330 Federal Register / Vol. 83, No. 113 / Tuesday, June 12, 2018 / Notices
actions. It should be noted that the 1997 (12 U.S.C. 1843). Unless otherwise A. Federal Reserve Bank of Richmond
policy statement was created at a time noted, nonbanking activities will be (Adam M. Drimer, Assistant Vice
when electronic communication was conducted throughout the United States. President) 701 East Byrd Street,
much less common than it is today and Unless otherwise noted, comments Richmond, Virginia 23219. Comments
no longer reflects the current practices regarding each of these applications can also be sent electronically to or
of the federal banking agencies in must be received at the Reserve Bank Comments.applications@rich.frb.org:
coordinating formal enforcement indicated or the offices of the Board of 1. CBM Bancorp Inc., Parkville,
actions. Importantly, the formal Governors not later than July 5, 2018. Maryland; to become a savings and loan
enforcement actions taken by the federal A. Federal Reserve Bank of Kansas holding company by merging with
banking agencies are now published on City (Dennis Denney, Assistant Vice Banks of Chesapeake, M.H.C. Parkville,
the individual agencies’ public President) 1 Memorial Drive, Kansas Maryland, and thereby indirectly
websites, making it no longer necessary City, Missouri 64198–0001: acquire Chesapeake Bank of Maryland,
for the agencies to provide written 1. Midwest Banc Holding Co., Pierce, Parkville, Maryland.
notice of all such actions to each other. Nebraska; to acquire up to 100 percent In connection with the proposal,
Moreover, the FRB, FDIC, and OCC have of the voting shares of Redstone Bank, Banks of Chesapeake M.H.C will convert
adopted a new policy that encourages Centennial, Colorado. from mutual to stock form.
notification to other interested federal Board of Governors of the Federal Reserve Board of Governors of the Federal Reserve
banking agencies at the earliest System, June 6, 2018. System, June 6, 2018.
practicable date and promotes Ann Misback, Ann Misback,
coordination among the FBAs related to Secretary of the Board. Secretary of the Board.
formal enforcement actions as [FR Doc. 2018–12596 Filed 6–11–18; 8:45 am]
appropriate. For the above reasons, the [FR Doc. 2018–12537 Filed 6–11–18; 8:45 am]
BILLING CODE 6210–01–P
1997 Policy Statement is being BILLING CODE 6210–01–P
rescinded.
Dated at Washington, DC, this 22nd day of FEDERAL RESERVE SYSTEM
May 2018. DEPARTMENT OF HEALTH AND
Federal Financial Institutions Examination Formations of, Acquisitions by, and HUMAN SERVICES
Council. Mergers of Savings and Loan Holding
Judith E. Dupre, Companies Food and Drug Administration
Executive Secretary. The companies listed in this notice [Docket No. FDA–2016–D–1164]
[FR Doc. 2018–12557 Filed 6–11–18; 8:45 am] have applied to the Board for approval,
Agency Information Collection
BILLING CODE 7535–01– 6714–01– 6210–01–4810–33– pursuant to the Home Owners’ Loan Act
4810–AM–P Activities; Submission for Office of
(12 U.S.C. 1461 et seq.) (HOLA),
Management and Budget Review;
Regulation LL (12 CFR part 238), and
Comment Request; Qualified Facility
Regulation MM (12 CFR part 239), and
FEDERAL RESERVE SYSTEM Attestation
all other applicable statutes and
Formations of, Acquisitions by, and regulations to become a savings and AGENCY: Food and Drug Administration,
Mergers of Bank Holding Companies loan holding company and/or to acquire HHS.
the assets or the ownership of, control ACTION: Notice.
The companies listed in this notice of, or the power to vote shares of a
have applied to the Board for approval, savings association and nonbanking SUMMARY: The Food and Drug
pursuant to the Bank Holding Company companies owned by the savings and Administration (FDA or we) is
Act of 1956 (12 U.S.C. 1841 et seq.) loan holding company, including the announcing that a proposed collection
(BHC Act), Regulation Y (12 CFR part companies listed below. of information has been submitted to the
225), and all other applicable statutes The applications listed below, as well Office of Management and Budget
and regulations to become a bank as other related filings required by the (OMB) for review and clearance under
holding company and/or to acquire the Board, are available for immediate the Paperwork Reduction Act of 1995.
assets or the ownership of, control of, or inspection at the Federal Reserve Bank DATES: Fax written comments on the
the power to vote shares of a bank or indicated. The application also will be collection of information by June 12,
bank holding company and all of the available for inspection at the offices of 2018.
banks and nonbanking companies the Board of Governors. Interested
owned by the bank holding company, persons may express their views in ADDRESSES: To ensure that comments on
including the companies listed below. writing on the standards enumerated in the information collection are received,
The applications listed below, as well the HOLA (12 U.S.C. 1467a(e)). If the OMB recommends that written
as other related filings required by the proposal also involves the acquisition of comments be faxed to the Office of
Board, are available for immediate a nonbanking company, the review also Information and Regulatory Affairs,
inspection at the Federal Reserve Bank includes whether the acquisition of the OMB, Attn: FDA Desk Officer, Fax: 202–
indicated. The applications will also be nonbanking company complies with the 395–7285, or emailed to oira_
available for inspection at the offices of standards in section 10(c)(4)(B) of the submission@omb.eop.gov. All
the Board of Governors. Interested HOLA (12 U.S.C. 1467a(c)(4)(B)). Unless comments should be identified with the
persons may express their views in OMB control number 0910—NEW and
sradovich on DSK3GMQ082PROD with NOTICES
otherwise noted, nonbanking activities
writing on the standards enumerated in will be conducted throughout the title ‘‘Qualified Facility Attestation.’’
the BHC Act (12 U.S.C. 1842(c)). If the United States. Also include the FDA docket number
proposal also involves the acquisition of Unless otherwise noted, comments found in brackets in the heading of this
a nonbanking company, the review also regarding each of these applications document.
includes whether the acquisition of the must be received at the Reserve Bank FOR FURTHER INFORMATION CONTACT:
nonbanking company complies with the indicated or the offices of the Board of Domini Bean, Office of Operations,
standards in section 4 of the BHC Act Governors not later than July 6, 2018. Food and Drug Administration, Three
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![27332 Federal Register / Vol. 83, No. 113 / Tuesday, June 12, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Guidance section FDA form responses per burden per Total hours
respondents responses
respondent response
Section II; Human Food ..................... 3942a 37,134 .5 18,567 .5 (30 minutes) .... 9,284
Section III; Animal Food .................... 3942b 1,120 .5 560 .5 (30 minutes) .... 280
Total ............................................ ........................ ........................ ........................ ........................ .............................. 9,564
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Consistent with the estimates found DEPARTMENT OF HEALTH AND Irradiation in the Production,
in our Preventive Controls for Human HUMAN SERVICES Processing, and Handling of Food
Food Rule, we estimate that OMB Control Number 0910–0186—
approximately 37,134 human food Food and Drug Administration
Extension
facilities will each spend approximately
30 minutes (0.5 hour) reporting their [Docket No. FDA–2018–N–0073] This information collection supports
status as a qualified facility to FDA FDA regulations. Specifically, under
every 2 years. Thus, dividing this figure Agency Information Collection sections 201(s) and 409 of the Federal
by two to determine the annual burden, Activities; Submission for Office of Food, Drug, and Cosmetic Act (FD&C
we estimate there will be 18,567 Management and Budget Review; Act) (21 U.S.C. 321(s) and 348), food
Comment Request; Irradiation in the irradiation is subject to regulation under
responses and 9,284 burden hours
Production, Processing, and Handling the food additive premarket approval
associated with this information
of Food provisions of the FD&C Act. The
collection element.
regulations providing for uses of
Similarly, and consistent with the AGENCY: Food and Drug Administration, irradiation in the production,
estimates found in our Preventive HHS. processing, and handling of food are
Controls for Animal Food Rule, we found in part 179 (21 CFR part 179). To
ACTION: Notice.
estimate that approximately 1,120 ensure safe use of a radiation source,
animal food facilities will each spend SUMMARY: The Food and Drug § 179.21(b)(1) requires that the label of
approximately 30 minutes (0.5 hour) Administration (FDA or we) is sources bear appropriate and accurate
reporting their status as a qualified announcing that a proposed collection information identifying the source of
facility to FDA every 2 years. Thus, of information has been submitted to the radiation and the maximum (or
dividing this figure by two to determine Office of Management and Budget minimum and maximum) energy of the
the annual burden, we estimate there (OMB) for review and clearance under emitted radiation. Section 179.21(b)(2)
will be 560 responses and 280 burden the Paperwork Reduction Act of 1995. requires that the label or accompanying
hours associated with this information labeling bear adequate directions for
collection element. DATES: Fax written comments on the installation and use and a statement
collection of information by July 12, supplied by FDA that indicates
The draft guidance also refers to 2018. maximum dose of radiation allowed.
previously approved collections of Section 179.26(c) requires that the label
information found in FDA regulations. ADDRESSES: To ensure that comments on or accompanying labeling bear a logo
The collections of information in 21 the information collection are received, and a radiation disclosure statement.
CFR part 117 have been approved under OMB recommends that written Section 179.25(e) requires that food
OMB control number 0910–0751. The comments be faxed to the Office of processors who treat food with radiation
collections of information in 21 CFR Information and Regulatory Affairs, make and retain, for 1 year past the
part 507 have been approved under OMB, Attn: FDA Desk Officer, Fax: 202– expected shelf life of the products up to
OMB control number 0910–0789. 395–7285, or emailed to oira_ a maximum of 3 years, specified records
submission@omb.eop.gov. All relating to the irradiation process (e.g.,
Dated: June 7, 2018. comments should be identified with the the food treated, lot identification,
Leslie Kux, OMB control number 0910–0186. Also scheduled process, etc.). The records
Associate Commissioner for Policy. include the FDA docket number found required by § 179.25(e) are used by FDA
[FR Doc. 2018–12615 Filed 6–11–18; 8:45 am] in brackets in the heading of this inspectors to assess compliance with the
BILLING CODE 4164–01–P
document. regulation that establishes limits within
FOR FURTHER INFORMATION CONTACT: Ila which radiation may be safely used to
Mizrachi, Office of Operations, Food treat food. We cannot ensure safe use
and Drug Administration, Three White without a method to assess compliance
Flint North, 10A–12M, 11601 with the dose limits, and there are no
Landsdown St., North Bethesda, MD practicable methods for analyzing most
foods to determine whether they have
sradovich on DSK3GMQ082PROD with NOTICES
20852, 301–796–7726, PRAStaff@
fda.hhs.gov. been treated with ionizing radiation and
are within the limitations set forth in
SUPPLEMENTARY INFORMATION: In part 179. Records inspection is the only
compliance with 44 U.S.C. 3507, FDA way to determine whether firms are
has submitted the following proposed complying with the regulations for
collection of information to OMB for treatment of foods with ionizing
review and clearance. radiation.
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Document Created: 2018-06-12 00:47:50
Document Modified: 2018-06-12 00:47:50
| 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 June 12, 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 27330 |
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