[Federal Register Volume 83, Number 46 (Thursday, March 8, 2018)]
[Notices]
[Pages 9856-9857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04630]


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

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.

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

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.gpo.gov/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, 
[email protected].

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