83 FR 9856 - Agency Information Collection Activities; Proposed Collection; Comment Request; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 46 (March 8, 2018)

Page Range		9856-9857
FR Document		2018-04630

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 record retention requirement of the soy protein/coronary heart disease health claim.

Federal Register, Volume 83 Issue 46 (Thursday, March 8, 2018)

[Federal Register Volume 83, Number 46 (Thursday, March 8, 2018)]
[Notices]
[Pages 9856-9857]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-04630]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0781]

Agency Information Collection Activities; Proposed Collection;
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.

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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 record retention requirement of the soy
protein/coronary heart disease health claim.

DATES: Submit either electronic or written comments on the collection
of information by May 7, 2018.

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 May 7, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of May 7, 2018. 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-0781 for ``Record Retention Requirements for the Soy Protein
and Risk of Coronary Heart Disease Health Claim.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.

[[Page 9857]]

``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.

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 (CHD).
Accordingly, FDA 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 21 CFR 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 (SSA) 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 the information collection as follows:

Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section Number of 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 upon our current experience with the use of health claims, we
estimate 25 firms market products bearing a soy protein/coronary heart
disease health claim and that perhaps one of each firm's products might
contain non-soy sources of protein along with soy protein. The records
currently required to be retained under Sec. 101.82(c)(2)(ii)(B) are
the 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, which we estimate will take 1 hour annually.

Dated: February 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04630 Filed 3-7-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 46 / Thursday, March 8, 2018 / Notices 9857

‘‘Collection of information’’ is defined assumptions used; (3) ways to enhance regulations authorizes a health claim for
in 44 U.S.C. 3502(3) and 5 CFR the quality, utility, and clarity of the food labels about soy protein and the
1320.3(c) and includes Agency requests information to be collected; and (4) risk of coronary heart disease (CHD).
or requirements that members of the ways to minimize the burden of the Accordingly, FDA established the
public submit reports, keep records, or collection of information on previously referenced information
provide information to a third party. respondents, including through the use collection in support of the regulation.
Section 3506(c)(2)(A) of the PRA (44 of automated collection techniques, In the Federal Register of October 31,
U.S.C. 3506(c)(2)(A)) requires Federal when appropriate, and other forms of 2017 (82 FR 50324), we published a
Agencies to provide a 60-day notice in information technology. proposed rule to revoke the underlying
the Federal Register concerning each regulation found at 21 CFR 101.82. We
proposed collection of information, Record Retention Requirements for the are taking this action based on our
including each proposed extension of an Soy Protein and Risk of Coronary Heart review of the totality of publicly
existing collection of information, Disease Health Claim—21 CFR 101.82 available scientific evidence currently
before submitting the collection to OMB OMB Control Number 0910–0428— available and our tentative conclusion
for approval. To comply with this Extension that such evidence does not support our
requirement, FDA is publishing notice previous determination that there is
of the proposed collection of Section 403(r)(3)(A) of the Federal significant scientific agreement (SSA)
information set forth in this document. Food, Drug, and Cosmetic Act (21 U.S.C. among qualified experts for a health
With respect to the following 343(r)(3)(A)) provides for the use of food claim regarding the relationship
collection of information, FDA invites label statements characterizing a between soy protein and reduced risk of
comments on these topics: (1) Whether relationship of any nutrient of the type coronary heart disease. Upon
the proposed collection of information required to be in the label or labeling of finalization of the proposed rule the
is necessary for the proper performance the food to a disease or a health related associated information collection
of FDA’s functions, including whether condition only where that statement requirements under this OMB Control
the information will have practical meets the requirements of the Number will be revoked. Until such
utility; (2) the accuracy of FDA’s regulations issued by the Secretary of time and in accordance with the PRA
estimate of the burden of the proposed Health and Human Services to authorize we retain our currently approved
collection of information, including the the use of such a health claim. Section burden estimate for the information
validity of the methodology and 101.82 (21 CFR 101.82) of our collection as follows:

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
21 CFR section records per burden per Total hours
recordkeepers records
recordkeeping 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 upon our current experience DEPARTMENT OF HEALTH AND disordered breathing (SDB) in adults.
with the use of health claims, we HUMAN SERVICES Study design considerations to be
estimate 25 firms market products discussed include definitions for SDB
bearing a soy protein/coronary heart Food and Drug Administration conditions, inclusion/exclusion criteria
disease health claim and that perhaps for studies of these conditions, use of
[Docket No. FDA–2018–N–0756] SDB assessment technologies, controls,
one of each firm’s products might
contain non-soy sources of protein along Study Design Considerations for and study endpoints.
with soy protein. The records currently Devices Including Digital Health DATES: The public workshop will be
required to be retained under Technologies for Sleep Disordered held on April 16, 2018, from 8 a.m. to
§ 101.82(c)(2)(ii)(B) are the records, e.g., Breathing in Adults; Public Workshop; 5 p.m. Submit either electronic or
the formulation or recipe, that a Request for Comments written comments on this public
manufacturer has and maintains as a workshop by April 30, 2018. See the
AGENCY: Food and Drug Administration,
normal course of its doing business. SUPPLEMENTARY INFORMATION section for
HHS.
Thus, the burden to the food registration date and information.
manufacturer is limited to assembling ACTION: Notice of public workshop;
request for comments. ADDRESSES: The public workshop will
and retaining the records, which we be held at FDA’s White Oak Campus,
estimate will take 1 hour annually. SUMMARY: The Food and Drug 10903 New Hampshire Ave., Bldg. 31
Dated: February 28, 2018. Administration (FDA, the Agency, or Conference Center, the Great Room (Rm.
Leslie Kux, we) is announcing the following public 1503), Silver Spring, MD 20993.
Associate Commissioner for Policy.
workshop entitled ‘‘Study Design Entrance for the public workshop
Considerations for Devices including participants (non-FDA employees) is
sradovich on DSK3GMQ082PROD with NOTICES

[FR Doc. 2018–04630 Filed 3–7–18; 8:45 am]
Digital Health Technologies for Sleep through Building 1 where routine
BILLING CODE 4164–01–P Disordered Breathing in Adults.’’ The security check procedures will be
topic to be discussed is the appropriate performed. For parking and security
design of clinical studies to evaluate information, please refer to https://
devices including digital health www.fda.gov/AboutFDA/Workingat
technologies intended for the diagnosis, FDA/BuildingsandFacilities/WhiteOak
monitoring, or treatment of sleep CampusInformation/ucm241740.htm.

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Document Created: 2018-03-08 01:47:53
Document Modified: 2018-03-08 01:47:53

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by May 7, 2018.
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]
FR Citation		83 FR 9856

83 FR 9856 - Agency Information Collection Activities; Proposed Collection; Comment Request; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 46 (March 8, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration