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

CourtFood And Drug Administration
Citation86 FR 68673
Record Number2021-26261
Publication Date03 December 2021
68673
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.
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
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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.
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/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 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:
T
ABLE
1—E
STIMATED
A
NNUAL
R
ECORDKEEPING
B
URDEN
1
Activity; 21 CFR section Number of
recordkeepers
Number of
records per
recordkeeper
2
Total
annual
records
Average
burden per
recordkeeping
Total
hours
Exemptions under §112.7 ................................................................... 3,285 1 3,285 0.5 (30 minutes) ........... 1,643
Training under §112.30 ....................................................................... 24,420 1 24,420 7.25 ............................... 177,045
Testing requirements for agricultural water under §§112.44 and
112.45. 48,361 2.990 144,599 0.825 (50 minutes) .... 119,294
Records related to agricultural water ................................................... 160,605 2.242 360,076 2.160 ............................. 777,765
Testing requirements for sprouts under §§112.144, 112.145, and
112.147. 126 245.660 30,953.16 0.825 (50 minutes) .... 25,536
Records related to sprouts ................................................................... 126 62.061 7,819.686 1.412 (85 minutes) .... 11,041
‘‘Compliance with and Recommendations for Implementation of the
Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption for Sprout Operations’’.
126 233 29,358 1 .................................... 29,358
Documentation supporting compliance with §112.2 ........................... 4,568 1 4,568 0.079 (5 minutes) ...... 361
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.
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68675
Federal Register / Vol. 86, No. 230 / Friday, December 3, 2021 / Notices
T
ABLE
2—E
STIMATED
A
NNUAL
T
HIRD
-P
ARTY
D
ISCLOSURE
B
URDEN
1
21 CFR section Number of
respondents
Number of
disclosures per
Respondent
Total
disclosures Average burden
per disclosure Total hours
Disclosure under §§112.2, 112.6, 112.31, 112.33, and 112.142 ....... 77,165 3.459 266,914 1.422 (85 minutes) .... 379,551
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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
: Food and Drug Administration,
HHS.
ACTION
: Notice.
SUMMARY
: 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
: 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
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
:
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.
SUPPLEMENTARY INFORMATION
: FDA is
requesting nominations for voting
members to fill upcoming vacancies on
the National Mammography Quality
Assurance Advisory Committee.
I. General Description of the Committee
Duties
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.
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]
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