Agency Information Collection Activities; Proposed Collection; Comment Request; Standards for the Growing, Harvesting, Packaging, and Holding of Produce for Human Consumption, 68673-68675 [2021-26261]

Download as PDF Federal Register / Vol. 86, No. 230 / Friday, December 3, 2021 / Notices will increase the funding level for SEDS–AK from $200,000 to $300,000. 3. Clarification to EMI NOFO In accordance with 42 U.S.C. 2991b– 3(c)(7), applicants for an EMI grant must submit an official document that certifies the applicant has at least 3 years of experience in operating and administering a Native American language survival school, a Native American language nest, or any other educational program in which instruction is conducted in a Native American language. ANA has decided not to fund applicants that did not provide the certification as required by law. To reiterate and also clarify, the applicant must provide the required certification of having not less than 3 years of experience in operating and administering a Native American language survival school, a Native American language nest, or any other educational program in which instruction is conducted in a Native American language. The applicant may partner with other eligible entities (as defined under Section III.1 Eligible Applicants in the NOFO) that do not have to meet the certification requirement. Statutory Authority: Section 814 of the Native American Programs Act of 1974 (NAPA), as amended. Hope MacDonald LoneTree, Deputy Commissioner, Administration for Native Americans. [FR Doc. 2021–26271 Filed 12–2–21; 8:45 am] BILLING CODE 4184–34–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0921] Agency Information Collection Activities; Proposed Collection; Comment Request; Standards for the Growing, Harvesting, Packaging, and Holding of Produce for Human Consumption AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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, jspears on DSK121TN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 18:06 Dec 02, 2021 Jkt 256001 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 associated with the standards for the growing, harvesting, packing, and holding of produce for human consumption. Submit either electronic or written comments on the collection of information by February 1, 2022. 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 February 1, 2022. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of February 1, 2022. 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. DATES: 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. PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 68673 • 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–0921 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Standards for the Growing, Harvesting, Packaging, and Holding of Produce for Human Consumption.’’ 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, 240–402–7500. • 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.govinfo.gov/content/pkg/FR-201509-18/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 E:\FR\FM\03DEN1.SGM 03DEN1 68674 Federal Register / Vol. 86, No. 230 / Friday, December 3, 2021 / Notices Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. 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. Under the PRA (44 U.S.C. 3501–3521), 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 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; 21 CFR Part 112 SUPPLEMENTARY INFORMATION: OMB Control Number 0910–0816— Extension To minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, we have established sciencebased minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. The standards are codified in part 112 (21 CFR part 112) and set forth procedures and processes that include information collection activities such as establishing monitoring and sampling plans, documenting data and training, and ensuring disclosure that produce for human consumption meets these requirements. The regulations also provide for certain exemptions and variances to qualified respondents. We use the information to verify that the standards established by the regulations are followed such that produce entering the marketplace is reasonably unlikely to be associated with foodborne illness. In addition to the referenced regulations, we have developed two draft guidance documents: ‘‘Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption’’ and ‘‘Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations;’’ both are available at https:// www.fda.gov/Food/Guidance Regulation/GuidanceDocuments RegulatoryInformation/default.htm. The former was developed to help covered farms comply with the requirements of the Produce Safety regulation. This draft guidance, when finalized, will not create any additional burden not already considered as part of the Produce Safety regulation. The latter (the Sprouts draft guidance) was developed to assist sprout operations also subject to the Produce Safety regulation. Sprouts represent a special food safety concern because the conditions under which they are produced (time, temperature, water activity, pH, and available nutrients) are ideal for the growth of pathogens, if present. The Sprouts draft guidance, when finalized, will assist sprout operations subject to the regulations in part 112 in complying with the sproutspecific requirements in subpart M. Description of Respondents: Respondents to this information collection include farms that grow, harvest, pack, or hold produce for human consumption, meaning fruits and vegetables such as berries, tree nuts, herbs, and sprouts. Respondents are from the private sector (for-profit businesses). We estimate the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers Activity; 21 CFR section jspears on DSK121TN23PROD with NOTICES1 Exemptions under § 112.7 ................................................................... Training under § 112.30 ....................................................................... Testing requirements for agricultural water under §§ 112.44 and 112.45. Records related to agricultural water ................................................... Testing requirements for sprouts under §§ 112.144, 112.145, and 112.147. Records related to sprouts ................................................................... ‘‘Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations’’. Documentation supporting compliance with § 112.2 ........................... Total .............................................................................................. 1 There Number of records per recordkeeper 2 Total annual records Average burden per recordkeeping 3,285 24,420 48,361 1 1 2.990 3,285 24,420 144,599 0.5 (30 minutes) ........... 7.25 ............................... 0.825 (∼ 50 minutes) .... 1,643 177,045 119,294 160,605 126 2.242 245.660 360,076 30,953.16 2.160 ............................. 0.825 (∼ 50 minutes) .... 777,765 25,536 126 126 62.061 233 7,819.686 29,358 1.412 (∼ 85 minutes) .... 1 .................................... 11,041 29,358 4,568 1 4,568 0.079 (∼ 5 minutes) ...... 361 605,079 .................................. 1,142,043 241,617 are no capital costs or operating and maintenance costs associated with this collection of information. rounded to nearest 1/1,000. 2 Numbers VerDate Sep<11>2014 19:01 Dec 02, 2021 Jkt 256001 PO 00000 Frm 00050 Total hours Fmt 4703 Sfmt 4703 E:\FR\FM\03DEN1.SGM 03DEN1 Federal Register / Vol. 86, No. 230 / Friday, December 3, 2021 / Notices 68675 TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN1 Number of respondents 21 CFR section Disclosure under §§ 112.2, 112.6, 112.31, 112.33, and 112.142 ....... 1 There Dated: November 23, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–26261 Filed 12–2–21; 8:45 am] BILLING CODE 4164–01–P 3.459 Regarding all nomination questions for membership: James P. Swink, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5211, Silver Spring, MD 20993, 301–796– 6313, James.Swink@fda.hhs.gov. Food and Drug Administration [Docket No. FDA–2018–N–0417] Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee AGENCY: mail to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993–0002. Information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA’s website at https:// www.fda.gov/AdvisoryCommittees/ default.htm. FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF HEALTH AND HUMAN SERVICES FDA is requesting nominations for voting members to fill upcoming vacancies on the National Mammography Quality Assurance Advisory Committee. SUPPLEMENTARY INFORMATION: Food and Drug Administration, HHS. jspears on DSK121TN23PROD with NOTICES1 77,165 Total disclosures 266,914 Average burden per disclosure 1.422 (∼ 85 minutes) .... Total hours 379,551 are no capital costs or operating or maintenance costs associated with this collection of information. Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. ACTION: Number of disclosures per Respondent Notice. SUMMARY: I. General Description of the Committee Duties All nominations for membership should be submitted electronically by logging into the FDA Advisory Nomination Portal at https:// www.accessdata.fda.gov/scripts/ FACTRSPortal/FACTRS/index.cfm or by The National Mammography Quality Assurance Advisory Committee advises the Commissioner of Food and Drugs (the Commissioner) or designee on: (1) Developing appropriate quality standards and regulations for mammography facilities; (2) developing appropriate standards and regulations for bodies accrediting mammography facilities under this program; (3) developing regulations with respect to sanctions; (4) developing procedures for monitoring compliance with standards; (5) establishing a mechanism to investigate consumer complaints; (6) reporting new developments concerning breast imaging that should be considered in the oversight of mammography facilities; (7) determining whether there exists a shortage of mammography facilities in rural and health professional shortage areas and determining the effects of personnel on access to the services of such facilities in such areas; (8) determining whether there will exist a sufficient number of medical physicists after October 1, 1999; and (9) determining the costs and benefits of compliance with these requirements. The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the National Mammography Quality Assurance Advisory Committee in the Center for Devices and Radiological Health. Nominations will be accepted for current and upcoming vacancies effective February 1, 2022, with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups. DATES: Nominations received on or before February 1, 2022, will be given first consideration for membership on the National Mammography Quality Assurance Advisory Committee. Nominations received after February 1, 2022, will be considered for nomination to the committee as later vacancies occur. ADDRESSES: VerDate Sep<11>2014 18:06 Dec 02, 2021 Jkt 256001 PO 00000 Frm 00051 Fmt 4703 Sfmt 9990 II. Criteria for Voting Members The committee consists of a core of 15 members, including the Chair. Members and the Chair are selected by the Commissioner or designee from among physicians, practitioners, and other health professionals, whose clinical practice, research specialization, or professional expertise includes a significant focus on mammography. Almost all non-Federal members of this committee serve as Special Government Employees. Members will be invited to serve for terms of up to 4 years. III. Nomination Procedures Any interested person may nominate one or more qualified persons for membership on the advisory committee. Self-nominations are also accepted. Nominations must include a current, complete re´sume´ or curriculum vitae for each nominee, including current business address, telephone number, and email address if available, and a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Nomination Portal (see ADDRESSES). Nominations must specify the advisory committee for which the nominee is recommended. Nominations must also acknowledge that the nominee is aware of the nomination unless self-nominated. FDA will ask potential candidates to provide detailed information concerning such matters related to financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflict of interest. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: November 29, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–26258 Filed 12–2–21; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\03DEN1.SGM 03DEN1

Agencies

[Federal Register Volume 86, Number 230 (Friday, December 3, 2021)]
[Notices]
[Pages 68673-68675]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26261]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0921]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Standards for the Growing, Harvesting, Packaging, and 
Holding of Produce for Human Consumption

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 associated with 
the standards for the growing, harvesting, packing, and holding of 
produce for human consumption.

DATES: Submit either electronic or written comments on the collection 
of information by February 1, 2022.

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 February 1, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of February 1, 2022. 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.
     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-0921 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Standards for the Growing, 
Harvesting, Packaging, and Holding of Produce for Human Consumption.'' 
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, 240-402-7500.
     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.govinfo.gov/content/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

[[Page 68674]]

Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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.

Standards for the Growing, Harvesting, Packing, and Holding of Produce 
for Human Consumption; 21 CFR Part 112

OMB Control Number 0910-0816--Extension

    To minimize the risk of serious adverse health consequences or 
death from consumption of contaminated produce, we have established 
science-based minimum standards for the safe growing, harvesting, 
packing, and holding of produce, meaning fruits and vegetables grown 
for human consumption. The standards are codified in part 112 (21 CFR 
part 112) and set forth procedures and processes that include 
information collection activities such as establishing monitoring and 
sampling plans, documenting data and training, and ensuring disclosure 
that produce for human consumption meets these requirements. The 
regulations also provide for certain exemptions and variances to 
qualified respondents. We use the information to verify that the 
standards established by the regulations are followed such that produce 
entering the marketplace is reasonably unlikely to be associated with 
foodborne illness.
    In addition to the referenced regulations, we have developed two 
draft guidance documents: ``Standards for the Growing, Harvesting, 
Packing, and Holding of Produce for Human Consumption'' and 
``Compliance with and Recommendations for Implementation of the 
Standards for the Growing, Harvesting, Packing, and Holding of Produce 
for Human Consumption for Sprout Operations;'' both are available at 
https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/default.htm. The former was 
developed to help covered farms comply with the requirements of the 
Produce Safety regulation. This draft guidance, when finalized, will 
not create any additional burden not already considered as part of the 
Produce Safety regulation.
    The latter (the Sprouts draft guidance) was developed to assist 
sprout operations also subject to the Produce Safety regulation. 
Sprouts represent a special food safety concern because the conditions 
under which they are produced (time, temperature, water activity, pH, 
and available nutrients) are ideal for the growth of pathogens, if 
present. The Sprouts draft guidance, when finalized, will assist sprout 
operations subject to the regulations in part 112 in complying with the 
sprout-specific requirements in subpart M.
    Description of Respondents: Respondents to this information 
collection include farms that grow, harvest, pack, or hold produce for 
human consumption, meaning fruits and vegetables such as berries, tree 
nuts, herbs, and sprouts. Respondents are from the private sector (for-
profit businesses).
    We estimate the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of
           Activity; 21 CFR section               Number of        records per     Total annual        Average burden per recordkeeping      Total hours
                                                recordkeepers   recordkeeper \2\      records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exemptions under Sec.   112.7................            3,285                 1           3,285  0.5 (30 minutes).........................        1,643
Training under Sec.   112.30.................           24,420                 1          24,420  7.25.....................................      177,045
Testing requirements for agricultural water             48,361             2.990         144,599  0.825 (~ 50 minutes).....................      119,294
 under Sec.  Sec.   112.44 and 112.45.
Records related to agricultural water........          160,605             2.242         360,076  2.160....................................      777,765
Testing requirements for sprouts under Sec.                126           245.660       30,953.16  0.825 (~ 50 minutes).....................       25,536
 Sec.   112.144, 112.145, and 112.147.
Records related to sprouts...................              126            62.061       7,819.686  1.412 (~ 85 minutes).....................       11,041
``Compliance with and Recommendations for                  126               233          29,358  1........................................       29,358
 Implementation of the Standards for the
 Growing, Harvesting, Packing, and Holding of
 Produce for Human Consumption for Sprout
 Operations''.
Documentation supporting compliance with Sec.            4,568                 1           4,568  0.079 (~ 5 minutes)......................          361
   112.2.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................          241,617  ................         605,079  .........................................    1,142,043
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers rounded to nearest 1/1,000.


[[Page 68675]]


                                               Table 2--Estimated Annual Third-Party Disclosure Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of
                21 CFR section                    Number of      disclosures per       Total            Average burden per disclosure        Total hours
                                                 respondents       Respondent       disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Disclosure under Sec.  Sec.   112.2, 112.6,             77,165             3.459         266,914  1.422 (~ 85 minutes).....................      379,551
 112.31, 112.33, and 112.142.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating or maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: November 23, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26261 Filed 12-2-21; 8:45 am]
BILLING CODE 4164-01-P

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