Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling: Draft Guidance for Industry; Availability, 62509-62511 [2016-21725]
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Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Notices
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: September 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–21688 Filed 9–8–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–2241]
Substantiation for Structure/Function
Claims Made in Infant Formula Labels
and Labeling: Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a draft
guidance for industry entitled
‘‘Substantiation for Structure/Function
Claims Made in Infant Formula Labels
and Labeling.’’ The draft guidance,
when finalized, will describe the type
and quality of evidence that we
recommend that infant formula
manufacturers and distributors have to
substantiate structure/function claims in
infant formula labels and labeling. This
draft guidance is intended to help infant
formula manufacturers making
structure/function claims comply with
the statutory requirement that all claims
in infant formula labeling must be
truthful and not misleading under the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act).
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that we consider
your comment on the draft guidance
before we begin work on the final
version of the guidance, submit either
electronic or written comments on the
draft guidance by November 8, 2016.
ADDRESSES: You may submit comments
as follows:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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
VerDate Sep<11>2014
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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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2016–D–2241 for ‘‘Substantiation for
Structure/Function Claims Made in
Infant Formula Labels and Labeling.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
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
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62509
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the draft guidance to the Office
of Nutrition and Food Labeling, Center
for Food Safety and Applied Nutrition
(HFS–800), Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740. Send two selfaddressed adhesive labels to assist that
office in processing your request. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance.
FOR FURTHER INFORMATION CONTACT:
With regard to this draft guidance:
Gillian Robert-Baldo, Center for Food
Safety and Applied Nutrition (HFS–
850), Food and Drug Administration,
5001 Campus Dr., College Park, MD
20740, 240–402–1451.
With regard to the information
collection issues: Domini Bean, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400T, Rockville, MD 20850,
domini.bean@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of
a draft guidance for industry entitled
‘‘Substantiation for Structure/Function
Claims Made in Infant Formula Labels
and Labeling.’’ We are issuing this draft
guidance consistent with our good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent our current
E:\FR\FM\09SEN1.SGM
09SEN1
62510
Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Notices
asabaliauskas on DSK3SPTVN1PROD with NOTICES
thinking on substantiation of structure/
function claims in infant formula labels
and labeling. It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternate approach if it satisfies the
requirements of the applicable statutes
and regulations.
The draft guidance, when finalized,
will describe the type and quality of
evidence we recommend that infant
formula manufacturers and distributors
have in their records to substantiate
their structure/function claims in the
labeling of infant formulas. It will
describe what we believe to be
competent and reliable scientific
evidence to substantiate structure/
function claims in the context of infant
formulas.
II. Paperwork Reduction Act of 1995
This draft guidance contains proposed
information collection provisions that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(the PRA) (44 U.S.C. 3501–3520).
‘‘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 for each proposed
collection of information before
submitting the collection to OMB for
approval. To comply with this
requirement, we are publishing this
notice of the proposed collection of
information set forth in this document.
With respect to the collection of
information associated with this draft
guidance, we invite 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 collected;
and (4) ways to minimize the burden of
the information collected on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Title: Recommended Recordkeeping
to Substantiate Structure/Function
Claims Made in Infant Formula Labels
and Labeling (OMB Control Number
0910—NEW).
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17:11 Sep 08, 2016
Jkt 238001
Description of respondents: This new
collection of information would be
performed by infant formula
manufacturers and distributors. The
records recommended, to the extent
practicable, in this draft guidance would
include one-time and annual
information collection burdens
pertaining to substantiation of structure/
function claims made by infant formula
manufacturers and distributors. In
addition, we have estimated the
information collection burden for any
future structure/function claims that
would involve controlled studies to
generate data to support those structure/
function claims.
The draft guidance document for
industry entitled ‘‘Substantiation for
Structure/Function Claims Made in
Infant Formula Labels and Labeling’’
addresses only structure/function
claims in infant formula labeling. It
describes the type and quality of
evidence we recommend infant formula
manufacturers and distributors have to
substantiate their structure/function
claims in labeling of both nonexempt
and exempt infant formulas under
section 403(a) of the FD&C Act (21
U.S.C. 343(a)(1)).
Analysis of Burden Estimates
Resulting From Substantiation for Infant
Formula Structure/Function Claims:
Infant formula manufacturers and
distributors would only collect
information to substantiate their
product’s structure/function claim if
they choose to place a structure/
function claim on their product’s label
or labeling. Gathering evidence on a
currently existing claim is estimated to
be a one-time burden; the respondents
would collect the substantiating
information for their product pursuant
to section 403(a) of the FD&C Act. We
recommend that infant formula
manufacturers and distributors
accurately maintain the substantiating
materials for these claims in their files.
We estimate that infant formula
manufacturers and distributors would
seek substantiation for their claims in
intervention studies and the scientific
literature and that this burden will
likely be comparable to the time needed
to assemble information for a new infant
formula submission (16 hours). In
addition, we estimate, based on
information available to FDA, that there
are currently 10 existing structure/
function claims for which infant
formula manufacturers would gather
substantiation data. Therefore, the total
one-time estimated burden imposed by
this collection of information would be
160 hours (16 estimated information
collection hours × 10 estimated existing
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structure/function claims), as shown in
table 1.
We have estimated the annual
information collection burdens for
maintenance of records related to
substantiation of existing structure/
function claims. We estimate that
respondents would spend 1 hour
annually maintaining records for each of
the 10 estimated currently existing
structure/function claims. Therefore, 1
hour × 10 claims = 10 annual hours, as
presented in table 1.
It is possible that an infant formula
manufacturer or distributor would want
to make a structure/function claim for
which there is equivocal or insufficient
evidence or no substantiating evidence.
In this case, we estimate that an infant
formula manufacturer or distributor
would conduct a controlled study in
order to gather data to substantiate the
structure/function claim. It is not
possible to know the frequency with
which this may occur; however, we
assume that an infant formula
manufacturer or distributor would
engage in a controlled study only if the
benefits to the infant formula
manufacturer or distributor were larger
than the costs of performing the study.
To account for the possibility that infant
formula manufacturers or distributors
would choose to conduct a controlled
study for the purpose of generating data
to substantiate a new structure/function
claim, in table 2 we estimate an
information collection burden based on
one hypothetical annual controlled
study. The burdens of this hypothetical
controlled study are based on averages
taken from three sample controlled
studies (Refs. 1, 2, and 3) and estimates
an average test subject size of 153
infants.
We estimate that a hypothetical
controlled study would involve, on
average, four recordkeepers: A principal
investigator (e.g., a physician), a sample
collector, one nurse or other health care
professional with similar experience,
and a microbiological laboratory
technologist. We estimate that the
principal investigator would work, on
average, 3 hours annually to assemble
and interpret the data collected per
study period. We estimate that one
sample collector would work an average
of 38.25 hours annually (153 infants ×
0.25 hours per infant = 38.25 hours) to
collect and record stool samples from
infants. We estimate that one nurse or
other health care professional with
similar experience would work an
average of 38.25 hours annually (153
infants × 0.25 hours per infant = 38.25
hours) to complete questionnaires on
the samples collected from the infants
in the study. We estimate that a
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Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Notices
microbiological laboratory technologist
would work an average of 76.5 hours
annually (153 infants × 0.5 hours per
infant = 76.5 hours) to prepare and
analyze fecal samples taken from infants
in the controlled study. All estimates
are shown in table 2. Therefore, a total
of 156 additional annual burden hours
(3 + 38.25 + 38.25 + 76.5 = 156) are
estimated to account for the information
collection burden resulting from the
need to conduct a controlled study in
order to gather data to substantiate a
new structure/function claim, or a
structure/function claim that lacks
sufficient prior evidence, for a total of
166 total annual hours (156 + 10 = 166)
for the upkeep and generation of
information used to substantiate
structure/function claims. Including the
one-time burden of 160 hours
annualized over 3 years (160/3 = 53.3),
the total annual record keeping burden
is 219.3 hours (166 + 53.3 = 219.3).
There are no estimated capital costs or
operating and maintenance costs
associated with this information
collection.
TABLE 1—ESTIMATED ONE-TIME HOURLY RECORDKEEPING BURDEN
Number of
respondents
Recordkeeping activity
First year
frequency of
recordkeeping
Total records
Hours per
record
Total hours
First Year Hourly Burden
Assembling Records Related to Substantiation of Existing
Structure/Function Claims ................................................
10
1
10
16
160
Total First Year Only Recordkeeping Burden ..............
........................
........................
........................
........................
*160
TABLE 2—RECORDKEEPING BURDEN
Annual
frequency of
recordkeeping
Number of
respondents
Recordkeeping activity
Total records
Hours per record
Total hours
Recurring Hourly Burden
*Annualized Recordkeeping Burden from Table 1
Maintaining Records Related to Substantiation of
Structure/Function Claims.
Controlled Study—Principal Investigator ..............
Controlled Study—Sample Collector ....................
Controlled Study—Nurse/Heath Care Professional.
Controlled Study—Lab Tech ................................
10
10
1
1
5.3
10
1 ....................................
1 ....................................
53.3
10
1
1
1
1
153
153
1
153
153
3 ....................................
0.25 (15 minutes) .........
0.25 (15 minutes) .........
3
38.25
38.25
1
153
153
0.5 (30 minutes) ...........
76.5
Total Recordkeeping Burden ........................
........................
........................
........................
.......................................
219.3
Before the proposed information
collection provisions contained in this
draft guidance become effective, we will
publish a notice in the Federal Register
announcing OMB’s decision to approve,
modify, or disapprove the proposed
information collection provisions. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/FoodGuidances or
https://www.regulations.gov. Use the
FDA Web site listed in the previous
sentence to find the most current
version of the guidance.
IV. References
The following references are on
display in the Division of Dockets
Management (see ADDRESSES) and are
available for viewing by interested
VerDate Sep<11>2014
17:11 Sep 08, 2016
Jkt 238001
persons between 9 a.m. and 4 p.m.,
Monday through Friday; they are also
available electronically at https://
www.regulations.gov.
1. Moro, G., F. Mosca, V. Miniello, et al.,
‘‘Effects of a New Mixture of Prebiotics
on Faecal Flora and Stools in Term
Infants.’’ Acta Paediatrica, 2003.
Supplement September 1991(441): pp.
77–79.
2. Boehm, G., M. Lidestri, P. Casetta,, et al.,
‘‘Supplementation of a Bovine Milk
Formula with an Oligosaccharide
Mixture Increases Counts of Faecal
Bifidobacteria in Preterm Infants.’’
Archives of Disease in Childhood Fetal
and Neonatal Edition, 2002. 86(3): pp.
F178–181.
3. Pickering, L.K., D.M. Granoff, J.R.
Erickson, et al., ‘‘Modulation of the
Immune System by Human Milk and
Infant Formula Containing Nucleotides.’’
Pediatrics, 1998. 101(2): pp. 242–249.
Dated: August 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–21725 Filed 9–8–16; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Maternal, Infant, and Early
Childhood Home Visiting Program
Cost Reporting Pilot Study
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, HRSA has
submitted an Information Collection
Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
SUMMARY:
E:\FR\FM\09SEN1.SGM
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Agencies
[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)]
[Notices]
[Pages 62509-62511]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21725]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-2241]
Substantiation for Structure/Function Claims Made in Infant
Formula Labels and Labeling: Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft guidance for industry entitled ``Substantiation
for Structure/Function Claims Made in Infant Formula Labels and
Labeling.'' The draft guidance, when finalized, will describe the type
and quality of evidence that we recommend that infant formula
manufacturers and distributors have to substantiate structure/function
claims in infant formula labels and labeling. This draft guidance is
intended to help infant formula manufacturers making structure/function
claims comply with the statutory requirement that all claims in infant
formula labeling must be truthful and not misleading under the Federal
Food, Drug, and Cosmetic Act (the FD&C Act).
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that we consider your comment on the draft
guidance before we begin work on the final version of the guidance,
submit either electronic or written comments on the draft guidance by
November 8, 2016.
ADDRESSES: You may submit comments as follows:
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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2016-D-2241 for ``Substantiation for Structure/Function Claims Made
in Infant Formula Labels and Labeling.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Division of Dockets Management 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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the draft guidance to
the Office of Nutrition and Food Labeling, Center for Food Safety and
Applied Nutrition (HFS-800), Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740. Send two self-addressed adhesive labels to
assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance.
FOR FURTHER INFORMATION CONTACT:
With regard to this draft guidance: Gillian Robert-Baldo, Center
for Food Safety and Applied Nutrition (HFS-850), Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1451.
With regard to the information collection issues: Domini Bean,
Office of Information Management, Food and Drug Administration, 1350
Piccard Dr., PI50-400T, Rockville, MD 20850, domini.bean@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a draft guidance for industry
entitled ``Substantiation for Structure/Function Claims Made in Infant
Formula Labels and Labeling.'' We are issuing this draft guidance
consistent with our good guidance practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will represent our current
[[Page 62510]]
thinking on substantiation of structure/function claims in infant
formula labels and labeling. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternate approach if it satisfies the requirements of the applicable
statutes and regulations.
The draft guidance, when finalized, will describe the type and
quality of evidence we recommend that infant formula manufacturers and
distributors have in their records to substantiate their structure/
function claims in the labeling of infant formulas. It will describe
what we believe to be competent and reliable scientific evidence to
substantiate structure/function claims in the context of infant
formulas.
II. Paperwork Reduction Act of 1995
This draft guidance contains proposed information collection
provisions that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44
U.S.C. 3501-3520). ``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 for each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, we are publishing this notice of the
proposed collection of information set forth in this document.
With respect to the collection of information associated with this
draft guidance, we invite 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 collected; and (4)
ways to minimize the burden of the information collected on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
Title: Recommended Recordkeeping to Substantiate Structure/Function
Claims Made in Infant Formula Labels and Labeling (OMB Control Number
0910--NEW).
Description of respondents: This new collection of information
would be performed by infant formula manufacturers and distributors.
The records recommended, to the extent practicable, in this draft
guidance would include one-time and annual information collection
burdens pertaining to substantiation of structure/function claims made
by infant formula manufacturers and distributors. In addition, we have
estimated the information collection burden for any future structure/
function claims that would involve controlled studies to generate data
to support those structure/function claims.
The draft guidance document for industry entitled ``Substantiation
for Structure/Function Claims Made in Infant Formula Labels and
Labeling'' addresses only structure/function claims in infant formula
labeling. It describes the type and quality of evidence we recommend
infant formula manufacturers and distributors have to substantiate
their structure/function claims in labeling of both nonexempt and
exempt infant formulas under section 403(a) of the FD&C Act (21 U.S.C.
343(a)(1)).
Analysis of Burden Estimates Resulting From Substantiation for
Infant Formula Structure/Function Claims: Infant formula manufacturers
and distributors would only collect information to substantiate their
product's structure/function claim if they choose to place a structure/
function claim on their product's label or labeling. Gathering evidence
on a currently existing claim is estimated to be a one-time burden; the
respondents would collect the substantiating information for their
product pursuant to section 403(a) of the FD&C Act. We recommend that
infant formula manufacturers and distributors accurately maintain the
substantiating materials for these claims in their files. We estimate
that infant formula manufacturers and distributors would seek
substantiation for their claims in intervention studies and the
scientific literature and that this burden will likely be comparable to
the time needed to assemble information for a new infant formula
submission (16 hours). In addition, we estimate, based on information
available to FDA, that there are currently 10 existing structure/
function claims for which infant formula manufacturers would gather
substantiation data. Therefore, the total one-time estimated burden
imposed by this collection of information would be 160 hours (16
estimated information collection hours x 10 estimated existing
structure/function claims), as shown in table 1.
We have estimated the annual information collection burdens for
maintenance of records related to substantiation of existing structure/
function claims. We estimate that respondents would spend 1 hour
annually maintaining records for each of the 10 estimated currently
existing structure/function claims. Therefore, 1 hour x 10 claims = 10
annual hours, as presented in table 1.
It is possible that an infant formula manufacturer or distributor
would want to make a structure/function claim for which there is
equivocal or insufficient evidence or no substantiating evidence. In
this case, we estimate that an infant formula manufacturer or
distributor would conduct a controlled study in order to gather data to
substantiate the structure/function claim. It is not possible to know
the frequency with which this may occur; however, we assume that an
infant formula manufacturer or distributor would engage in a controlled
study only if the benefits to the infant formula manufacturer or
distributor were larger than the costs of performing the study. To
account for the possibility that infant formula manufacturers or
distributors would choose to conduct a controlled study for the purpose
of generating data to substantiate a new structure/function claim, in
table 2 we estimate an information collection burden based on one
hypothetical annual controlled study. The burdens of this hypothetical
controlled study are based on averages taken from three sample
controlled studies (Refs. 1, 2, and 3) and estimates an average test
subject size of 153 infants.
We estimate that a hypothetical controlled study would involve, on
average, four recordkeepers: A principal investigator (e.g., a
physician), a sample collector, one nurse or other health care
professional with similar experience, and a microbiological laboratory
technologist. We estimate that the principal investigator would work,
on average, 3 hours annually to assemble and interpret the data
collected per study period. We estimate that one sample collector would
work an average of 38.25 hours annually (153 infants x 0.25 hours per
infant = 38.25 hours) to collect and record stool samples from infants.
We estimate that one nurse or other health care professional with
similar experience would work an average of 38.25 hours annually (153
infants x 0.25 hours per infant = 38.25 hours) to complete
questionnaires on the samples collected from the infants in the study.
We estimate that a
[[Page 62511]]
microbiological laboratory technologist would work an average of 76.5
hours annually (153 infants x 0.5 hours per infant = 76.5 hours) to
prepare and analyze fecal samples taken from infants in the controlled
study. All estimates are shown in table 2. Therefore, a total of 156
additional annual burden hours (3 + 38.25 + 38.25 + 76.5 = 156) are
estimated to account for the information collection burden resulting
from the need to conduct a controlled study in order to gather data to
substantiate a new structure/function claim, or a structure/function
claim that lacks sufficient prior evidence, for a total of 166 total
annual hours (156 + 10 = 166) for the upkeep and generation of
information used to substantiate structure/function claims. Including
the one-time burden of 160 hours annualized over 3 years (160/3 =
53.3), the total annual record keeping burden is 219.3 hours (166 +
53.3 = 219.3). There are no estimated capital costs or operating and
maintenance costs associated with this information collection.
Table 1--Estimated One-Time Hourly Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
First year
Recordkeeping activity Number of frequency of Total records Hours per Total hours
respondents recordkeeping record
----------------------------------------------------------------------------------------------------------------
First Year Hourly Burden
----------------------------------------------------------------------------------------------------------------
Assembling Records Related to 10 1 10 16 160
Substantiation of Existing
Structure/Function Claims......
-------------------------------------------------------------------------------
Total First Year Only .............. .............. .............. .............. *160
Recordkeeping Burden.......
----------------------------------------------------------------------------------------------------------------
Table 2--Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Annual
Recordkeeping activity Number of frequency of Total records Hours per record Total hours
respondents recordkeeping
----------------------------------------------------------------------------------------------------------------
Recurring Hourly Burden
----------------------------------------------------------------------------------------------------------------
*Annualized Recordkeeping 10 1 5.3 1............... 53.3
Burden from Table 1.
Maintaining Records Related to 10 1 10 1............... 10
Substantiation of Structure/
Function Claims.
Controlled Study--Principal 1 1 1 3............... 3
Investigator.
Controlled Study--Sample 1 153 153 0.25 (15 38.25
Collector. minutes).
Controlled Study--Nurse/Heath 1 153 153 0.25 (15 38.25
Care Professional. minutes).
Controlled Study--Lab Tech.... 1 153 153 0.5 (30 minutes) 76.5
---------------------------------------------------------------------------------
Total Recordkeeping Burden .............. .............. .............. ................ 219.3
----------------------------------------------------------------------------------------------------------------
Before the proposed information collection provisions contained in
this draft guidance become effective, we will publish a notice in the
Federal Register announcing OMB's decision to approve, modify, or
disapprove the proposed information collection provisions. An Agency
may not conduct or sponsor, and a person is not required to respond to,
a collection of information unless it displays a currently valid OMB
control number.
III. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA Web site listed in the previous
sentence to find the most current version of the guidance.
IV. References
The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov.
1. Moro, G., F. Mosca, V. Miniello, et al., ``Effects of a New
Mixture of Prebiotics on Faecal Flora and Stools in Term Infants.''
Acta Paediatrica, 2003. Supplement September 1991(441): pp. 77-79.
2. Boehm, G., M. Lidestri, P. Casetta,, et al., ``Supplementation of
a Bovine Milk Formula with an Oligosaccharide Mixture Increases
Counts of Faecal Bifidobacteria in Preterm Infants.'' Archives of
Disease in Childhood Fetal and Neonatal Edition, 2002. 86(3): pp.
F178-181.
3. Pickering, L.K., D.M. Granoff, J.R. Erickson, et al.,
``Modulation of the Immune System by Human Milk and Infant Formula
Containing Nucleotides.'' Pediatrics, 1998. 101(2): pp. 242-249.
Dated: August 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21725 Filed 9-8-16; 8:45 am]
BILLING CODE 4164-01-P