Request for Comments on the Food and Drug Administration Safety and Innovation Act Section 907 Report, 52202-52203 [2013-20352]
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Federal Register / Vol. 78, No. 163 / Thursday, August 22, 2013 / Notices
(Response 1) FDA agrees with the
comments.
(Comment 2) Reacting to FDA’s
declaration in the 60-day notice (77 FR
48988), that it intends to use ‘‘a mock
snack product’’ to study nutrient
content claims on fortified foods, one
comment requested that FDA limit
testing of such claims to sugars, cookies,
candy, and carbonated beverages.
(Response 2) FDA agrees with the
comment. FDA will limit testing of
nutrient content claims on fortified
introduce brand effects, a bias that may
be difficult to separate from effects of
the claims themselves, which is the
focus of the studies.
Recent study design decisions have
indicated that the Agency needs a larger
sample size for Study 1 than originally
expected; therefore, the Agency will not
conduct Study 2 (a shopping simulation
study) which was described in the 60day notice.
FDA estimates the burden of this
collection of information as follows:
snack foods to mock cookies, candy, and
carbonated beverages.
(Comment 3) One comment requested
that FDA use images of actual
commercially available labels for
fortified snack products in the study
instead of the proposed mock snack
food labels, claiming that use of actual
labels will increase the external validity
of the studies.
(Response 3) FDA disagrees with the
comment. Actual labels will increase
the external validity of the findings but
actual labels also are highly likely to
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity
Total annual
responses
Average burden
per response
Cognitive interview screener ..........................
75
1
75
Cognitive interview .........................................
9
1
9
Pretest invitation .............................................
1,600
1
1,600
Pretest ............................................................
400
1
400
Survey invitation .............................................
32,000
1
32,000
Survey .............................................................
7,500
1
7,500
Total .........................................................
........................
........................
........................
1 There
0.083 ...................................
(5 minutes)
1 hour ..................................
(60 minutes)
0.033 ...................................
(2 minutes)
0.25 .....................................
(15 minutes)
0.033 ...................................
(2 minutes)
0.25 .....................................
(15 minutes)
.............................................
6
9
53
100
1,056
1,875
3,099
are no capital costs or operating and maintenance costs associated with this collection of information.
II. References
The following references have been
placed on display in the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at https://
www.regulations.gov. (FDA has verified
the Web site addresses, but we are not
responsible for any subsequent changes
to the Web sites after this document
publishes in the Federal Register.)
tkelley on DSK3SPTVN1PROD with NOTICES
Total hours
1. U.S. Food and Drug Administration.
Claims That Can Be Made for Conventional
Foods and Dietary Supplements. September
2003. Available at https://www.fda.gov/Food/
IngredientsPackagingLabeling/
LabelingNutrition/ucm111447.htm.
2. Drichoutis, A.C., P. Lazaridis, and R.M.
Nayga, ‘‘Consumers’ Use of Nutritional
Labels: A Review of Research Studies and
Issues,’’ Academy of Marketing Science
Review, 2006(9), 2006. Available at https://
www.amsreview.org/articles/drichoutis09–
2006.pdf.
¨
¨
3. Lahteenmaki, L., P. Lampila, and K.
Grunert, et al., ‘‘Impact of Health-Related
Claims on the Perception of Other Product
Attributes,’’ Food Policy, 23: 230–239, 2010.
4. Labiner-Wolfe, J., C.-T. J. Lin, and L.
Verrill, ‘‘Effect of Low Carbohydrate Claims
VerDate Mar<15>2010
18:44 Aug 21, 2013
Jkt 229001
on Consumer Perceptions about Food
Products’ Healthfulness and Helpfulness for
Weight Management,’’ Journal of Nutrition
Education and Behavior, 42(5): 315–320,
2010.
5. Roe, B., A.S. Levy, and B.M. Derby, ‘‘The
Impact of Health Claims on Consumer Search
and Product Evaluation Outcomes: Evidence
from FDA Experimental Data,’’ Journal of
Public Policy and Marketing, 18(1): 89–105,
1999.
Dated: August 16, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–20469 Filed 8–21–13; 8:45 am]
Submit electronic or written
comments by November 20, 2013.
DATES:
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0745]
Request for Comments on the Food
and Drug Administration Safety and
Innovation Act Section 907 Report
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of docket;
request for comments.
ACTION:
PO 00000
Frm 00076
Fmt 4703
The Food and Drug
Administration (FDA) is announcing the
establishment of a public docket for
comments pertaining to the report
issued as required by section 907 of the
Food and Drug Administration Safety
and Innovation Act (FDASIA). This
notice is intended to solicit input from
all relevant stakeholders before FDA
issues an action plan to address issues
raised in the report and to announce
that such information submitted to FDA
is available to all interested persons in
a timely fashion.
SUMMARY:
Sfmt 4703
Submit electronic
comments to https://www.regulations.
gov. Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. All comments should be
identified with the docket number
found in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Pamela E. Scott, Office of Women’s
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32,
Rm. 2320, Silver Spring, MD 20903,
E:\FR\FM\22AUN1.SGM
22AUN1
Federal Register / Vol. 78, No. 163 / Thursday, August 22, 2013 / Notices
available to all interested persons in a
timely fashion.
SUPPLEMENTARY INFORMATION:
II. Comments
I. Background
tkelley on DSK3SPTVN1PROD with NOTICES
301–796–9441, FDASIASECTION907@
fda.hhs.gov.
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
On July 9, 2012, the President signed
FDASIA (Pub. L. 112–144) into law.
Section 907 of FDASIA requires that
FDA report on and address certain
information regarding clinical trial
participation by demographic subgroups
and subset analysis of the resulting data.
Specifically, section 907(a) of FDASIA
requires the Secretary of Health and
Human Services (the Secretary), acting
through the FDA Commissioner, to
publish on FDA’s Internet Web site a
report ‘‘addressing the extent to which
clinical trial participation and the
inclusion of safety and effectiveness
data by demographic subgroups
including sex, age, race, and ethnicity,
is included in applications submitted to
the FDA,’’ and provide such publication
to Congress. The report entitled
‘‘Reporting of Inclusion of Demographic
Subgroups in Clinical Trials and Data
Analysis in Applications for Drugs,
Biologics, and Devices’’ is available at
https://www.fda.gov/Regulatory
Information/Legislation/FederalFood
DrugandCosmeticActFDCAct/
SignificantAmendmentstotheFDCAct/
FDASIA/ucm356316.htm.
Section 907(b) of FDASIA further
requires the Secretary, again acting
through the Commissioner, to publish
an action plan on the Internet Web site
of FDA and provide such publication to
Congress. The action plan is to contain
recommendations, as appropriate, to
improve the completeness and quality
of analyses of data on demographic
subgroups in summaries of product
safety and effectiveness and in labeling;
on the inclusion of such data, or the
lack of availability of such data in
labeling; and on ways to improve public
availability of such data to patients,
health care providers, and researchers.
These recommendations are to include,
as appropriate, a determination that
distinguishes between product types
and applicability. The action plan is due
not later than 1 year after the
publication of the report described
previously.
FDA is opening a docket for 90 days
to provide an opportunity for interested
individuals to submit comments on the
report for use in the development of the
action plan. When submitting comments
please reference the section of the report
to which your comments pertain. This
docket is intended to ensure that
stakeholders have an opportunity to
provide comments and that such
information submitted to FDA is
VerDate Mar<15>2010
17:07 Aug 21, 2013
Jkt 229001
Dated: August 16, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–20352 Filed 8–20–13; 11:15 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0277]
Guidance for Industry on Compliance
With Regulations Restricting the Sale
and Distribution of Cigarettes and
Smokeless Tobacco To Protect
Children and Adolescents; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Compliance With Regulations
Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco to
Protect Children and Adolescents.’’ This
guidance is intended to help small
entities and other stakeholders comply
with FDA’s regulations restricting the
sale and distribution of cigarettes and
smokeless tobacco to protect children
and adolescents.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Center for Tobacco Products, Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850–3229. Send
one self-addressed adhesive label to
assist that office in processing your
request or include a fax number to
which the guidance document may be
sent. See the SUPPLEMENTARY
SUMMARY:
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
52203
INFORMATION section for information on
electronic access to the guidance.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Identify comments with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Office of Compliance and Enforcement,
Center for Tobacco Products, Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850–3229, 877–
287–1373, ctpcompliance@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The Family Smoking Prevention and
Tobacco Control Act (Tobacco Control
Act) (Pub. L. 111–31; 123 Stat. 1776)
was enacted on June 22, 2009, amending
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) and providing FDA with
authority to regulate tobacco products.
Section 102 of the Tobacco Control Act
requires FDA to publish final
regulations regarding cigarettes and
smokeless tobacco which are identical
in their provisions to the regulations
issued by FDA on August 28, 1996 (61
FR 44396), with certain specified
exceptions. In the Federal Register of
March 19, 2010 (75 FR 13225), FDA
published its final regulations entitled
‘‘Regulations Restricting the Sale and
Distribution of Cigarettes and Smokeless
Tobacco to Protect Children and
Adolescents,’’ codified at 21 CFR part
1140. The final regulations apply to
manufacturers, distributors, and
retailers who manufacture, distribute, or
sell cigarettes or smokeless tobacco
products.
These regulations took effect on June
22, 2010, and impose restrictions on
sales and distribution, including youth
access, and advertising and labeling of
cigarettes, including roll-your-own
tobacco, cigarette tobacco, and
smokeless tobacco. For instance,
retailers are: Prohibited from selling
cigarettes, including roll-your-own
tobacco, cigarette tobacco, or smokeless
tobacco to persons under the age of 18;
required to verify the age of all
customers under the age of 27 by
checking a photographic identification
that includes the bearer’s date of birth;
and prohibited from distributing free
samples of cigarettes.
FDA announced the publication of a
draft guidance document on this subject
on June 9, 2010 (75 FR 32791), and
issued a revised draft guidance on
March 23, 2011 (76 FR 16424), to
E:\FR\FM\22AUN1.SGM
22AUN1
]]>Agencies
[Federal Register Volume 78, Number 163 (Thursday, August 22, 2013)]
[Notices]
[Pages 52202-52203]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20352]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0745]
Request for Comments on the Food and Drug Administration Safety
and Innovation Act Section 907 Report
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of docket; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
establishment of a public docket for comments pertaining to the report
issued as required by section 907 of the Food and Drug Administration
Safety and Innovation Act (FDASIA). This notice is intended to solicit
input from all relevant stakeholders before FDA issues an action plan
to address issues raised in the report and to announce that such
information submitted to FDA is available to all interested persons in
a timely fashion.
DATES: Submit electronic or written comments by November 20, 2013.
ADDRESSES: Submit electronic comments to https://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Pamela E. Scott, Office of Women's
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, Rm. 2320, Silver Spring, MD 20903,
[[Page 52203]]
301-796-9441, FDASIASECTION907@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On July 9, 2012, the President signed FDASIA (Pub. L. 112-144) into
law. Section 907 of FDASIA requires that FDA report on and address
certain information regarding clinical trial participation by
demographic subgroups and subset analysis of the resulting data.
Specifically, section 907(a) of FDASIA requires the Secretary of Health
and Human Services (the Secretary), acting through the FDA
Commissioner, to publish on FDA's Internet Web site a report
``addressing the extent to which clinical trial participation and the
inclusion of safety and effectiveness data by demographic subgroups
including sex, age, race, and ethnicity, is included in applications
submitted to the FDA,'' and provide such publication to Congress. The
report entitled ``Reporting of Inclusion of Demographic Subgroups in
Clinical Trials and Data Analysis in Applications for Drugs, Biologics,
and Devices'' is available at https://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm356316.htm.
Section 907(b) of FDASIA further requires the Secretary, again
acting through the Commissioner, to publish an action plan on the
Internet Web site of FDA and provide such publication to Congress. The
action plan is to contain recommendations, as appropriate, to improve
the completeness and quality of analyses of data on demographic
subgroups in summaries of product safety and effectiveness and in
labeling; on the inclusion of such data, or the lack of availability of
such data in labeling; and on ways to improve public availability of
such data to patients, health care providers, and researchers. These
recommendations are to include, as appropriate, a determination that
distinguishes between product types and applicability. The action plan
is due not later than 1 year after the publication of the report
described previously.
FDA is opening a docket for 90 days to provide an opportunity for
interested individuals to submit comments on the report for use in the
development of the action plan. When submitting comments please
reference the section of the report to which your comments pertain.
This docket is intended to ensure that stakeholders have an opportunity
to provide comments and that such information submitted to FDA is
available to all interested persons in a timely fashion.
II. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
Dated: August 16, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20352 Filed 8-20-13; 11:15 am]
BILLING CODE 4160-01-P
