Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim, 21748-21749 [2021-08480]
Download as PDF
<![CDATA[
21748
Federal Register / Vol. 86, No. 77 / Friday, April 23, 2021 / Notices
TABLE 4—CDRH GUIDANCE AND COLLECTIONS
CFR cite referenced in
COVID–19 guidance
COVID–19 guidance title
Policy for Evaluating Impact of Viral Mutations on
COVID–19 Tests (February 2021).
IV. Electronic Access
Persons with access to the internet
may obtain COVID–19-related guidances
at:
• FDA web page entitled ‘‘COVID–19Related Guidance Documents for
Industry, FDA Staff, and Other
Stakeholders,’’ available at https://
www.fda.gov/emergency-preparednessand-response/mcm-issues/covid-19related-guidance-documents-industryfda-staff-and-other-stakeholders;
• FDA web page entitled ‘‘Search for
FDA Guidance Documents’’ available at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments; or
• https://www.regulations.gov.
Dated: April 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–08474 Filed 4–22–21; 8:45 am]
BILLING CODE 4164–01–P
Another guidance title referenced in COVID–19
guidance
Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Other Stakeholders.
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
(PRA).
Submit written comments
(including recommendations) on the
collection of information by May 24,
2021.
DATES:
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 0910–0428. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0781]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Record Retention
Requirements for the Soy Protein and
Risk of Coronary Heart Disease Health
Claim
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance. Record Retention
Requirements for the Soy Protein and
Risk of Coronary Heart Disease Health
SUPPLEMENTARY INFORMATION:
Claim—21 CFR 101.82
OMB Control Number 0910–0428—
Extension
Notice.
The Food and Drug
Administration (FDA) is announcing
Section 403(r)(3)(A) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
SUMMARY:
OMB control
No(s).
0910–0595
343(r)(3)(A)) provides for the use of food
label statements characterizing a
relationship of any nutrient of the type
required to be in the label or labeling of
the food to a disease or a health related
condition only where that statement
meets the requirements of the
regulations issued by the Secretary of
Health and Human Services to authorize
the use of such a health claim. Section
101.82 (21 CFR 101.82) of our
regulations authorizes a health claim for
food labels about soy protein and the
risk of coronary heart disease.
Accordingly, we established the
previously referenced information
collection in support of the regulation.
In the Federal Register of October 31,
2017 (82 FR 50324), we published a
proposed rule to revoke the underlying
regulation found at § 101.82. We are
taking this action based on our review
of the totality of publicly available
scientific evidence currently available
and our tentative conclusion that such
evidence does not support our previous
determination that there is significant
scientific agreement among qualified
experts for a health claim regarding the
relationship between soy protein and
reduced risk of coronary heart disease.
Upon finalization of the proposed rule,
the associated information collection
requirements under this OMB control
number will be revoked. Until such time
and in accordance with the PRA, we
retain our currently approved burden
estimate for this information collection.
In the Federal Register of October 21,
2020 (85 FR 66999), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
khammond on DSKJM1Z7X2PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR section
Number
recordkeepers
Number of
records per
recordkeeping
25
1
101.82(c)(2)(ii)(B) .................................................................
1 There
Total annual
records
25
Average
burden per
recordkeeping
1
Total hours
25
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
VerDate Sep<11>2014
18:15 Apr 22, 2021
Jkt 253001
OMB approval, we have made no
adjustments to our burden estimate. The
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
records currently required to be retained
under § 101.82(c)(2)(ii)(B) are the
E:\FR\FM\23APN1.SGM
23APN1
Federal Register / Vol. 86, No. 77 / Friday, April 23, 2021 / Notices
records, e.g., the formulation or recipe,
that a manufacturer has and maintains
as a normal course of its doing business.
Thus, the burden to the food
manufacturer is limited to assembling
and retaining the records.
Dated: April 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–08480 Filed 4–22–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1584]
Authorization of Emergency Use of
Certain Medical Devices During
COVID–19; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of Emergency Use
Authorizations (EUAs) (the
Authorizations) for certain medical
devices related to the Coronavirus
Disease 2019 (COVID–19) public health
emergency. FDA has issued the
Authorizations listed in this document
under the Federal Food, Drug, and
Cosmetic Act (FD&C Act). These
Authorizations contain, among other
things, conditions on the emergency use
of the authorized products. The
Authorizations follow the February 4,
2020, determination by the Secretary of
Health and Human Services (HHS) that
there is a public health emergency that
has a significant potential to affect
national security or the health and
security of U.S. citizens living abroad,
and that involves the virus that causes
COVID–19, and the subsequent
declarations on February 4, 2020, March
2, 2020, and March 24, 2020, that
circumstances exist justifying the
authorization of emergency use of in
vitro diagnostics for detection and/or
diagnosis of the virus that causes
COVID–19, personal respiratory
protective devices, and medical devices,
including alternative products used as
medical devices, respectively, subject to
the terms of any authorization issued
under the FD&C Act. These
Authorizations, which include an
explanation of the reasons for issuance,
are listed in this document, and are
available on FDA’s website at the links
indicated.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:15 Apr 22, 2021
Jkt 253001
These Authorizations are
effective on their date of issuance.
ADDRESSES: Submit written requests for
single copies of an EUA to the Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 1, Rm.
4338, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist that office in processing your
request or include a Fax number to
which the Authorization may be sent.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
Authorization.
FOR FURTHER INFORMATION CONTACT:
Jennifer J. Ross, Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 1, Rm.
4332, Silver Spring, MD 20993–0002,
301–796–8510 (this is not a toll free
number).
SUPPLEMENTARY INFORMATION:
DATES:
I. Background
Section 564 of the FD&C Act (21
U.S.C. 360bbb–3) allows FDA to
strengthen the public health protections
against biological, chemical,
radiological, or nuclear agent or agents.
Among other things, section 564 of the
FD&C Act allows FDA to authorize the
use of an unapproved medical product
or an unapproved use of an approved
medical product in certain situations.
With this EUA authority, FDA can help
ensure that medical countermeasures
may be used in emergencies to diagnose,
treat, or prevent serious or lifethreatening diseases or conditions
caused by a biological, chemical,
radiological, or nuclear agent or agents
when there are no adequate, approved,
and available alternatives.
Section 564(b)(1) of the FD&C Act
provides that, before an EUA may be
issued, the Secretary of HHS must
declare that circumstances exist
justifying the authorization based on
one of the following grounds: (1) A
determination by the Secretary of
Homeland Security that there is a
domestic emergency, or a significant
potential for a domestic emergency,
involving a heightened risk of attack
with a biological, chemical, radiological,
or nuclear agent or agents; (2) a
determination by the Secretary of
Defense that there is a military
emergency, or a significant potential for
a military emergency, involving a
heightened risk to U.S. military forces,
including personnel operating under the
authority of title 10 or title 50 of the
U.S. Code, of attack with (A) a
biological, chemical, radiological, or
nuclear agent or agents; or (B) an agent
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
21749
or agents that may cause, or are
otherwise associated with, an
imminently life-threatening and specific
risk to U.S. military forces; 1 (3) a
determination by the Secretary of HHS
that there is a public health emergency,
or a significant potential for a public
health emergency, that affects, or has a
significant potential to affect, national
security or the health and security of
U.S. citizens living abroad, and that
involves a biological, chemical,
radiological, or nuclear agent or agents,
or a disease or condition that may be
attributable to such agent or agents; or
(4) the identification of a material threat
by the Secretary of Homeland Security
pursuant to section 319F–2 of the Public
Health Service (PHS) Act (42 U.S.C.
247d–6b) sufficient to affect national
security or the health and security of
U.S. citizens living abroad.
Once the Secretary of HHS has
declared that circumstances exist
justifying an authorization under
section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug,
device, or biological product if the
Agency concludes that the statutory
criteria are satisfied. Under section
564(h)(1) of the FD&C Act, FDA is
required to publish in the Federal
Register a notice of each authorization,
and each termination or revocation of an
authorization, and an explanation of the
reasons for the action. Under section
564(h)(1) of the FD&C Act, revisions to
an authorization shall be made available
on the internet website of FDA.
Section 564 of the FD&C Act permits
FDA to authorize the introduction into
interstate commerce of a drug, device, or
biological product intended for use
when the Secretary of HHS has declared
that circumstances exist justifying the
authorization of emergency use.
Products appropriate for emergency use
may include products and uses that are
not approved, cleared, or licensed under
section 505, 510(k), 512, or 515 of the
FD&C Act (21 U.S.C. 355, 360(k), 360b,
or 360e) or section 351 of the PHS Act
(42 U.S.C. 262), or conditionally
approved under section 571 of the FD&C
Act (21 U.S.C. 360ccc). FDA may issue
an EUA only if, after consultation with
the HHS Assistant Secretary for
Preparedness and Response, the
Director of the National Institutes of
Health, and the Director of the Centers
for Disease Control and Prevention
(CDC) (to the extent feasible and
appropriate given the applicable
1 In the case of a determination by the Secretary
of Defense, the Secretary of HHS shall determine
within 45 calendar days of such determination,
whether to make a declaration under section
564(b)(1) of the FD&C Act, and, if appropriate, shall
promptly make such a declaration.
E:\FR\FM\23APN1.SGM
23APN1
]]>Agencies
[Federal Register Volume 86, Number 77 (Friday, April 23, 2021)]
[Notices]
[Pages 21748-21749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08480]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0781]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Record Retention
Requirements for the Soy Protein and Risk of Coronary Heart Disease
Health Claim
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) 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 (PRA).
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 0910-0428. 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. Record Retention Requirements for the Soy Protein
and Risk of Coronary Heart Disease Health
Claim--21 CFR 101.82
OMB Control Number 0910-0428--Extension
Section 403(r)(3)(A) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 343(r)(3)(A)) provides for the use of food label statements
characterizing a relationship of any nutrient of the type required to
be in the label or labeling of the food to a disease or a health
related condition only where that statement meets the requirements of
the regulations issued by the Secretary of Health and Human Services to
authorize the use of such a health claim. Section 101.82 (21 CFR
101.82) of our regulations authorizes a health claim for food labels
about soy protein and the risk of coronary heart disease. Accordingly,
we established the previously referenced information collection in
support of the regulation.
In the Federal Register of October 31, 2017 (82 FR 50324), we
published a proposed rule to revoke the underlying regulation found at
Sec. 101.82. We are taking this action based on our review of the
totality of publicly available scientific evidence currently available
and our tentative conclusion that such evidence does not support our
previous determination that there is significant scientific agreement
among qualified experts for a health claim regarding the relationship
between soy protein and reduced risk of coronary heart disease. Upon
finalization of the proposed rule, the associated information
collection requirements under this OMB control number will be revoked.
Until such time and in accordance with the PRA, we retain our currently
approved burden estimate for this information collection.
In the Federal Register of October 21, 2020 (85 FR 66999), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section Number records per Total annual per Total hours
recordkeepers recordkeeping records recordkeeping
----------------------------------------------------------------------------------------------------------------
101.82(c)(2)(ii)(B)............. 25 1 25 1 25
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and 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. The records currently required to be retained under Sec.
101.82(c)(2)(ii)(B) are the
[[Page 21749]]
records, e.g., the formulation or recipe, that a manufacturer has and
maintains as a normal course of its doing business. Thus, the burden to
the food manufacturer is limited to assembling and retaining the
records.
Dated: April 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-08480 Filed 4-22-21; 8:45 am]
BILLING CODE 4164-01-P
