Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Requirements, 21754-21756 [2021-08470]
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Federal Register / Vol. 86, No. 77 / Friday, April 23, 2021 / Notices
III. Participating in the Public
Workshop
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Registration: Persons interested in
attending this public workshop must
register online by May 26, 2021, at
https://www.eventbrite.com/e/modelinformed-drug-developmentapproaches-for-immunogenicityassessments-tickets-138618787525.
Please provide complete contact
information for each attendee, including
name, title, affiliation, address, email,
and telephone. Registration is free and
based on space availability, with
priority given to early registrants.
If you need special accommodations
due to a disability, please contact Loni
Warren Henderson or Sherri Revell (see
FOR FURTHER INFORMATION CONTACT) no
later than May 26, 2021. Please note,
Computer Aided Realtime Translation/
captioning will be available.
Streaming Webcast of the Public
Workshop: This public workshop will
be streamed via webcast only.
If you have never attended a Connect
Pro event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. FDA has
verified the website addresses in this
document as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
Transcripts: Please be advised that as
soon as a transcript of the public
workshop is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Dockets Management Staff (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, 240–402–7500. A link to the
transcript will also be available on the
internet at https://www.fda.gov/
vaccines-blood-biologics/news-eventsbiologics/workshops-meetingsconferences-biologics.
Food and Drug Administration
Dated: April 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
Infant Formula Requirements—21 CFR
parts 106 and 107
khammond on DSKJM1Z7X2PROD with NOTICES
[FR Doc. 2021–08487 Filed 4–22–21; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
18:15 Apr 22, 2021
Jkt 253001
[Docket No. FDA–2010–N–0190]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Infant Formula
Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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: Submit written comments
(including recommendations) on the
collection of information by May 24,
2021.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0256. Also include
the FDA docket number found in
brackets in the heading of this
document.
SUMMARY:
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, PRAStaff@
fda.hhs.gov.
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.
OMB Control Number 0910–0256—
Extension
Statutory requirements for infant
formula under the Federal Food, Drug,
and Cosmetic Act (FD&C Act) are
intended to protect the health of infants
and include a number of reporting and
recordkeeping requirements. Among
other things, section 412 of the FD&C
Act (21 U.S.C. 350a) requires
manufacturers of infant formula to
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Fmt 4703
Sfmt 4703
establish and adhere to quality control
procedures, notify us when infant
formula that has left the manufacturers’
control may be adulterated or
misbranded, and keep records of
distribution. We have issued regulations
to implement the FD&C Act’s
requirements for infant formula in parts
106 and 107 (21 CFR parts 106 and 107).
We also regulate the labeling of infant
formula under the authority of section
403 of the FD&C Act (21 U.S.C. 343).
Under our labeling regulations for infant
formula in part 107, the label of an
infant formula must include nutrient
information and directions for use.
Failure to comply with any of the
applicable labeling regulations will
render an infant formula misbranded
under section 403 of the FD&C Act. The
purpose of these labeling requirements
is to ensure that consumers have the
information they need to prepare and
use infant formula appropriately.
While the infant formula regulations
help ensure the consistent production of
safe and nutritionally adequate infant
formulas for healthy term infants, they
apply with one narrow exception.
Section 412(h)(1) of the FD&C Act
exempts an infant formula represented
and labeled for use by an infant with an
inborn error of metabolism, low birth
weight, or who otherwise has an
unusual medical or dietary problem
from the requirements of subsections
412(a), (b), and (c) of the FD&C Act.
These formulas are customarily referred
to as ‘‘exempt infant formulas.’’ Section
412(h)(2) of the FD&C Act authorizes us
to establish terms and conditions for the
exemption of an infant formula from the
requirements of subsections 412(a), (b),
and (c) of the FD&C Act.
In support of exempt infant formulas,
we have issued the Agency guidance
document entitled ‘‘Exempt Infant
Formula Production: Current Good
Manufacturing Practices (CGMPs),
Quality Control Procedures, Conduct of
Audits, and Records and Reports.’’ The
guidance document includes our
recommendation that manufacturers of
exempt infant formulas follow, to the
extent practicable, subparts A, B, C, D,
and F of 21 CFR part 106, and is
available at https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/guidanceindustry-exempt-infant-formulaproduction.
We have also developed electronic
Form FDA 3978 (Infant Formula
Tracking System (IFTRACK)) so that
infant formula manufacturers may
electronically submit reports and
notifications in a standardized format to
FDA. However, manufacturers that
prefer to submit paper submissions in a
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Federal Register / Vol. 86, No. 77 / Friday, April 23, 2021 / Notices
format of their own choosing will still
have the option to do so. Form FDA
3978 prompts a respondent to include
reports and notifications in a standard
electronic format and helps the
respondent organize their submission to
include only the information needed for
our review. Screenshots of Form FDA
3978 and instructions are available at
https://www.fda.gov/Food/Guidance
Regulation/FoodFacilityRegistration/
InfantFormula/default.htm.
Description of Respondents:
Respondents to this information
collection are manufacturers of infant
formula.
In the Federal Register of December 2,
2020 (85 FR 77469), we published a 60day notice requesting public comment
on the proposed collection of
information. Two comments were
received providing general comment
regarding requirements for infant
formula labeling; however, neither
comment requested revision to the
burden estimates.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
FD&C Act or 21 CFR Section
Total annual
responses
Average burden per
response
Total hours
Reports; Section 412(d) of the FD&C Act ...........
Notifications; § 106.120(b) ....................................
Reports for exempt infant formula; § 107.50(b)(3)
and (4).
Notifications
for
exempt
infant
formula;
§ 107.50(e)(2).
Requirements for quality factors—growth monitoring study exemption; § 106.96(c).
Requirements for quality factors—Protein Efficiency Ratio exemption; § 106.96(g).
New infant formula registration; § 106.110 ..........
5
1
3
13
1
2
65
1
6
10 ..................................
4 ....................................
4 ....................................
650
4
24
1
1
1
4 ....................................
4
4
9
36
20 ..................................
720
1
34
34
12 ..................................
408
4
9
36
18
New infant formula submission; § 106.120 ..........
4
9
36
0.50 ...............................
(30 minutes) ..................
10 ..................................
360
Total ..............................................................
........................
........................
........................
.......................................
2,188
1 There
are no capital or operating and maintenance costs associated with the information collection.
Based on a review of the information
collection, we have adjusted our burden
estimate to correct a nominal
calculation error. This reflects a
decrease of 62 annual responses and a
corresponding decrease of 308 annual
hours.
In compiling these estimates, we
consulted our records of the number of
infant formula submissions received in
the past. All infant formula submissions
may be provided to us in electronic
format. The hours per response
reporting estimates are based on our
experience with similar programs and
information received from industry.
The total estimated annual reporting
burden is 2,188 hours, as shown in table
1.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2
Number of
recordkeepers
FD&C Act or 21 CFR Part
Part 106—subpart B: ...........................................................
CGMP Requirements ...........................................................
Part 106—subparts C through G: Quality control; audits;
quality factors; records and reports .................................
Part 107—subpart C; Exempt infant formulas .....................
Exempt infant formula production; GMP; audits, recordkeeping, and reports ........................................................
Total ..............................................................................
1 There
Number of
records per
recordkeeper
Total
annual records
Average
burden per
recordkeeping
5
429.8
2,149
4.4
9,414
5
3
726.8
10
3,634
30
6
300
21,818
9,000
3
634
1,902
45
85,590
........................
........................
........................
........................
125,822
are no capital costs or operating and maintenance costs associated with the information.
have been rounded.
khammond on DSKJM1Z7X2PROD with NOTICES
2 Numbers
The total estimated annual
recordkeeping burden is 125,822 hours,
as shown in table 2.
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Federal Register / Vol. 86, No. 77 / Friday, April 23, 2021 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Activity; 21 CFR Section
Number of
respondents
Number of
disclosures
per respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Nutrient labeling; 107.10(a) and 107.20 ..............................
5
13
65
8
520
1 There
are no capital costs or operating and maintenance costs associated with the information collection.
We estimate compliance with our
infant formula labeling requirements in
21 CFR 107.10(a) and 107.20 requires
520 hours annually.
Dated: April 15, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–08470 Filed 4–22–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: Health Center
Program: COVID–19 Data Collection
Tools, OMB No. 0906–0062—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than June 22, 2021.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
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SUMMARY:
VerDate Sep<11>2014
18:15 Apr 22, 2021
Jkt 253001
When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Health Center Program: COVID–19 Data
Collection Tools, OMB No. 0906–0062—
Revision.
Abstract: This information collection
request was previously approved by
OMB on June 11, 2020, as an emergency
clearance (OMB No.: 0906–0062). HRSA
is currently undertaking the standard
Paperwork Reduction Act process for
normal OMB approval.
During the COVID–19 public health
emergency, HRSA-supported health
centers and Federally Qualified Health
Center Look-Alikes (look-alikes) have
played a key role in providing testing
and care for those affected by the virus.
HRSA awarded billions of dollars in
new funding to support health center
awardees and look-alikes in the
detection, prevention, diagnosis, and
treatment of COVID–19. This funding
has enabled health centers to maintain
or increase their staffing levels, conduct
training, provide COVID–19 treatment,
and administer millions of tests for both
existing and new patients. In addition,
HRSA, in collaboration with Centers for
Disease Control and Prevention,
launched the Health Center COVID–19
Vaccine program as part of a White
House initiative focused on health
equity. This occurred in February 2021
to directly allocate COVID–19 vaccines
to HRSA-supported health centers.
This ICR to support the
implementation of COVID–19 relief
funding and response activities includes
forms previously submitted in the
emergency information collection
request clearance: (1) Health Center
COVID–19 Data Collection Survey Tool,
(2) Addendum to COVID–19 Data
Collection Survey Tool, and (3) the
Health Center COVID–19 Vaccine
Program Readiness Assessment Tool.
This revised information collection
request includes two newly added
forms: (1) Primary Care Association
(PCA) COVID–19 Data Collection
Survey Tool 1 and (2) the Health Center
SUPPLEMENTARY INFORMATION:
1 The bi-weekly COVID–19 PCA Survey Tool
(comprised of six questions) is currently approved
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Sfmt 4703
COVID–19 Vaccine Program Conditions
of Participation Agreement.
Need and Proposed Use of the
Information: HRSA uses the data
collected to optimize COVID–19 testing
and vaccination; track health center
capacity and the impact of COVID–19
on operations, patients, and staff; and
better understand training and technical
assistance, funding, and other health
center resource needs. The data allow
HRSA to assess health center capacity
prior to program enrollment, supporting
successful vaccine allocation strategies
while providing HRSA with information
on the effectiveness of vaccine
distribution through this program. In
addition, the data inform HRSA in
resource allocation and technical
assistance to health centers.
The readiness assessment supports
HRSA’s analysis of health center ability
to successfully participate in the Health
Center COVID–19 Vaccine Program.
These data are critical to determine
health center capacity to implement the
vaccination program as well as comply
with program requirements. These data
are used to assess program readiness
including:
• Ability to safely store the vaccine
• Availability of trained and
credentialed staff and other staff
capacity
• Reporting capacity
• Sufficient Personal Protective
Equipment
• Plan for vaccine transport
The health center weekly survey and
addendum support HRSA’s ability to
monitor progress towards the
development and delivery of COVID–19
prevention, preparedness, and/or
response activities and ensure
appropriate vaccine administration as
well as better understand training and
technical assistance, funding, and other
health center resource needs.
The Conditions of Participation
Agreement governs all COVID–19
vaccination activities at all health center
sites that receive COVID–19 vaccine
through the HRSA Health Center
under the HHS Secretary’s Public Health
Emergency Authority to waive the requirements of
the Paperwork Reduction Act during the Public
Health Emergency for reporting on a voluntary
basis.
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]]>Agencies
[Federal Register Volume 86, Number 77 (Friday, April 23, 2021)]
[Notices]
[Pages 21754-21756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08470]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0190]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Infant Formula
Requirements
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: Submit written comments (including recommendations) on the
collection of information by May 24, 2021.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0256. 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 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.
Infant Formula Requirements--21 CFR parts 106 and 107
OMB Control Number 0910-0256--Extension
Statutory requirements for infant formula under the Federal Food,
Drug, and Cosmetic Act (FD&C Act) are intended to protect the health of
infants and include a number of reporting and recordkeeping
requirements. Among other things, section 412 of the FD&C Act (21
U.S.C. 350a) requires manufacturers of infant formula to establish and
adhere to quality control procedures, notify us when infant formula
that has left the manufacturers' control may be adulterated or
misbranded, and keep records of distribution. We have issued
regulations to implement the FD&C Act's requirements for infant formula
in parts 106 and 107 (21 CFR parts 106 and 107). We also regulate the
labeling of infant formula under the authority of section 403 of the
FD&C Act (21 U.S.C. 343). Under our labeling regulations for infant
formula in part 107, the label of an infant formula must include
nutrient information and directions for use. Failure to comply with any
of the applicable labeling regulations will render an infant formula
misbranded under section 403 of the FD&C Act. The purpose of these
labeling requirements is to ensure that consumers have the information
they need to prepare and use infant formula appropriately.
While the infant formula regulations help ensure the consistent
production of safe and nutritionally adequate infant formulas for
healthy term infants, they apply with one narrow exception. Section
412(h)(1) of the FD&C Act exempts an infant formula represented and
labeled for use by an infant with an inborn error of metabolism, low
birth weight, or who otherwise has an unusual medical or dietary
problem from the requirements of subsections 412(a), (b), and (c) of
the FD&C Act. These formulas are customarily referred to as ``exempt
infant formulas.'' Section 412(h)(2) of the FD&C Act authorizes us to
establish terms and conditions for the exemption of an infant formula
from the requirements of subsections 412(a), (b), and (c) of the FD&C
Act.
In support of exempt infant formulas, we have issued the Agency
guidance document entitled ``Exempt Infant Formula Production: Current
Good Manufacturing Practices (CGMPs), Quality Control Procedures,
Conduct of Audits, and Records and Reports.'' The guidance document
includes our recommendation that manufacturers of exempt infant
formulas follow, to the extent practicable, subparts A, B, C, D, and F
of 21 CFR part 106, and is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-exempt-infant-formula-production.
We have also developed electronic Form FDA 3978 (Infant Formula
Tracking System (IFTRACK)) so that infant formula manufacturers may
electronically submit reports and notifications in a standardized
format to FDA. However, manufacturers that prefer to submit paper
submissions in a
[[Page 21755]]
format of their own choosing will still have the option to do so. Form
FDA 3978 prompts a respondent to include reports and notifications in a
standard electronic format and helps the respondent organize their
submission to include only the information needed for our review.
Screenshots of Form FDA 3978 and instructions are available at https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/InfantFormula/default.htm.
Description of Respondents: Respondents to this information
collection are manufacturers of infant formula.
In the Federal Register of December 2, 2020 (85 FR 77469), we
published a 60-day notice requesting public comment on the proposed
collection of information. Two comments were received providing general
comment regarding requirements for infant formula labeling; however,
neither comment requested revision to the burden estimates.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
FD&C Act or 21 CFR Section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Reports; Section 412(d) of the 5 13 65 10.............. 650
FD&C Act.
Notifications; Sec. 1 1 1 4............... 4
106.120(b).
Reports for exempt infant 3 2 6 4............... 24
formula; Sec. 107.50(b)(3)
and (4).
Notifications for exempt 1 1 1 4............... 4
infant formula; Sec.
107.50(e)(2).
Requirements for quality 4 9 36 20.............. 720
factors--growth monitoring
study exemption; Sec.
106.96(c).
Requirements for quality 1 34 34 12.............. 408
factors--Protein Efficiency
Ratio exemption; Sec.
106.96(g).
New infant formula 4 9 36 0.50............ 18
registration; Sec. 106.110. (30 minutes)....
New infant formula submission; 4 9 36 10.............. 360
Sec. 106.120.
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 2,188
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with the information collection.
Based on a review of the information collection, we have adjusted
our burden estimate to correct a nominal calculation error. This
reflects a decrease of 62 annual responses and a corresponding decrease
of 308 annual hours.
In compiling these estimates, we consulted our records of the
number of infant formula submissions received in the past. All infant
formula submissions may be provided to us in electronic format. The
hours per response reporting estimates are based on our experience with
similar programs and information received from industry.
The total estimated annual reporting burden is 2,188 hours, as
shown in table 1.
Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
FD&C Act or 21 CFR Part Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Part 106--subpart B:............ 5 429.8 2,149 4.4 9,414
CGMP Requirements...............
Part 106--subparts C through G: 5 726.8 3,634 6 21,818
Quality control; audits;
quality factors; records and
reports........................
Part 107--subpart C; Exempt 3 10 30 300 9,000
infant formulas................
Exempt infant formula 3 634 1,902 45 85,590
production; GMP; audits,
recordkeeping, and reports.....
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 125,822
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with the information.
\2\ Numbers have been rounded.
The total estimated annual recordkeeping burden is 125,822 hours,
as shown in table 2.
[[Page 21756]]
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity; 21 CFR Section Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nutrient labeling; 107.10(a) and 107.20............................ 5 13 65 8 520
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with the information collection.
We estimate compliance with our infant formula labeling
requirements in 21 CFR 107.10(a) and 107.20 requires 520 hours
annually.
Dated: April 15, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-08470 Filed 4-22-21; 8:45 am]
BILLING CODE 4164-01-P
