[Federal Register Volume 84, Number 34 (Wednesday, February 20, 2019)]
[Notices]
[Pages 5084-5086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02806]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0721]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Accreditation of Third-Party Certification Bodies To 
Conduct Food Safety Audits and Issue Certifications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, 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 information collection 
requirements for the accreditation of third-party certification bodies 
to conduct food safety audits and issue certifications.

DATES: Submit either electronic or written comments on the collection 
of information by April 22, 2019.

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 April 22, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 22, 2019. Comments

[[Page 5085]]

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.
     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-2019-N-0721 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Accreditation of Third-Party 
Certification Bodies to Conduct Food Safety Audits and Issue 
Certifications.'' 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.gpo.gov/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, 
[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.

Accreditation of Third-Party Certification Bodies To Conduct Food 
Safety Audits and To Issue Certifications--21 CFR Part 1; Subpart M

OMB Control Number 0910-0750--Extension

    FDA provides for accreditation of third-party certification bodies 
(CBs) to conduct food safety audits of eligible foreign food 
facilities, and issue food and facility certifications, pursuant to the 
FDA Food Safety Modernization Act. In accordance with 21 CFR part 
1.600, Subpart M, FDA uses certifications issued by accredited third-
party auditors/CBs in deciding whether to admit certain imported food 
into the United States that FDA has determined poses a food safety risk 
and in deciding whether an importer is eligible to participate in a 
program for expedited review and entry of food imports. Except for 
limited circumstances in which we may directly accredit CBs to 
participate in the accredited third-party audits and certification 
program, we will recognize accreditation bodies (ABs) to accredit 
third-party auditors/CBs. Use of accredited third-party CBs and food 
and facility certifications has helped us prevent potentially harmful 
food from reaching U.S. consumers and thereby improve the safety of the 
U.S. food supply. This collection of

[[Page 5086]]

information increases efficiency by reducing the number of redundant 
audits to assess compliance with applicable food safety requirements of 
the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA 
regulations.
    We estimate that there are about 200,000 foreign food and feed 
exporters that offer their food and feed for import into the United 
States. These foreign food and feed exporters include approximately 
130,000 food and feed production facilities and approximately 71,000 
farms. A proportion of these foreign food and feed exporters may offer 
food subject to mandatory certification requirements under section 
801(q) of the FD&C Act (21 U.S.C. 381(q)(3)). In that case, the 
eligible entities must either comply with this collection of 
information to obtain certification from a CB accredited under the 
third-party program to continue exporting their food products into the 
United States, or a foreign government designated by FDA, or lose their 
access to U.S. markets. We assume that in any given year, 75 foreign 
food and feed exporters will be subject to section 801(q) of the FD&C 
Act.
    We estimate that 25 ABs will accredit CBs that will conduct food 
safety audits of foreign eligible entities that offer food or feed for 
import to the United States. We also estimate that approximately 207 
CBs accredited by the 25 AB applicants will comply with the collection 
of information to participate in the program. In addition, we expect 
that one CB will apply and participate in the third-party program via 
direct accreditation by FDA under this collection of information.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                                  Number of
           21 CFR part 1; subpart M               Number of      records per    Total annual    Avg. burden per recordkeeping (in hours)    Total hours
                                                recordkeepers   recordkeeper       records
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Sec.   1.625.................................              25             426          10,600  0.25 (15 minutes)........................           2,663
Sec.   1.624(c)..............................              25               1              25  8........................................             200
Sec.   1.657(d)..............................             208               1             208  8........................................           1,664
Sec.   1.652.................................             208            48.5          10,088  0.083 (5 minutes)........................             837
Sec.   1.653(b)(2)...........................             208            48.5          10,088  0.083 (5 minutes)........................             837
Sec.   1.656(c)..............................             208            0.25              52  1........................................              52
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    Total Annual Recordkeeping Burden........  ..............  ..............  ..............  .........................................           6,253
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\1\ There are no operations and maintenance costs associated with annual recordkeeping burden.


                                                     Table 2--Estimated Annual Reporting Burden \1\
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                                                                  Number of
           21 CFR part 1; subpart M               Number of     responses per   Total annual      Avg. burden per response (in hours)       Total hours
                                                 respondents     respondent       responses
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Sec.   1.634.................................              25               1              25  8........................................             200
Sec.   1.673.................................               1               1               1  10.......................................              10
Sec.   1.623(a)..............................              25            8.79             220  0.25 (15 minutes)........................              55
Sec.   1.623(b)..............................              25               1              25  0.25 (15 minutes)........................               6
Sec.   1.653(b)(1)...........................             208            48.5          10,088  0.25 (15 minutes)........................           2,522
Sec.   1.656(a) \2\..........................             207            48.5          10,040  0.25 (15 minutes)........................           2,510
Sec.   1.656(a) \3\..........................             207            48.5          10,040  0.25 (15 minutes)........................           2,510
Sec.   1.656(a) \4\..........................               1            55.4              55  0.25 (15 minutes)........................              14
Sec.   1.656(b) \5\..........................             207               1             207  0.25 (15 minutes)........................              52
Sec.   1.656(b) \6\..........................               1               1               1  0.25 (15 minutes)........................               1
Sec.   1.656(c)..............................             208            0.25              52  0.25 (15 minutes)........................              13
Sec.   1.656(e) \7\..........................             208            0.25              52  0.25 (15 minutes)........................              13
Sec.   1.656(e) \8\..........................             207            0.25              52  0.25 (15 minutes)........................              13
                                              ----------------------------------------------------------------------------------------------------------
    Total Annual Reporting Burden............  ..............  ..............  ..............  .........................................           7,919
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\1\ There are no operating or maintenance costs associated with annual reporting.
\2\ Annual reporting of regulatory audit reports by CBs accredited by recognized ABs to their accrediting ABs.
\3\ Annual reporting of regulatory audit reports by CBs accredited by recognized ABs to the FDA.
\4\ Annual reporting of regulatory audit reports by directly accredited CBs to the FDA.
\5\ Annual reporting of self-assessment by accredited CBs to their recognized ABs.
\6\ Annual reporting of self-assessment by directly-accredited CBs to the FDA.
\7\ Annual reporting of serious risk to public health by CBs accredited under the third-party program to eligible entities.
\8\ Annual reporting of serious risk to public health by accredited CBs to their recognized ABs.

    The total annual recordkeeping burden by 25 recognized ABs and 208 
CBs accredited under the third-party program is estimated at 6,253 
hours (see table 1). We assume that all ABs that apply for recognition 
in the program become recognized and all CBs that apply for 
accreditation are accredited. The total annual reporting burden by 25 
recognized ABs and 208 CBs accredited under the program is estimated at 
7,919 hours (see table 2).
    We have adjusted our burden estimate since last OMB approval of the 
information collection to reflect the removal of burden associated with 
one-time recordkeeping activities resulting from the implementation of 
new provisions. This results in an overall decrease of 60,650 annual 
burden hours.

    Dated: February 13, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02806 Filed 2-19-19; 8:45 am]
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