National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting, 35121 [2019-15463]
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35121
Federal Register / Vol. 84, No. 140 / Monday, July 22, 2019 / Notices
an annual recurring recordkeeping
burden of 216 hours, as reflected in
table 1, row 7. Adding the burden from
new products to the burden for existing
products results in a total of 187,914
annual recordkeeping burden hours.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Filing of citizen petition regarding a particular isolated or synthetic non-digestible carbohydrate
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Dietary Fiber; 101.9(c)(6)(i) .......................................
28
1
28
1
28
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
Manufacturers of food products that
contain an isolated or synthetic nondigestible carbohydrate that is not listed
in the definition of dietary fiber have
the option of submitting a citizen
petition to FDA requesting us to amend
the definition of ‘‘dietary fiber’’ to
include the carbohydrate as a listed
dietary fiber, by demonstrating the
physiological benefits of the isolated or
synthetic non-digestible carbohydrate to
human health.
We estimate that there are
approximately 28 isolated or synthetic
non-digestible carbohydrates that do not
meet the definition of dietary fiber.
Once a citizen petition filed by a
manufacturer related to a particular
isolated or synthetic non-digestible
carbohydrate is granted or denied, or the
carbohydrate is the subject of an
authorized health claim, and the dietary
fiber is listed in the definition of dietary
fiber, the use of the dietary fiber as an
ingredient in any food product must be
included in the total amount of dietary
fiber declared in nutrition labeling for
such product.
Thus, we estimate that 28
manufacturers would incur burden
associated with filing a citizen petition
to amend the listing of dietary fiber
related to an isolated and synthetic nondigestible carbohydrate that is not
currently listed in the definition of
dietary fiber and that the required
recordkeeping would be 1 hour per
manufacturer. This calculation is shown
in table 2.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
21 CFR 101.9
Number of
respondents
Number of
disclosures
per respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Nutritional labeling for new products .........................
500
1
500
2
1,000
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1
There are no capital costs or operating and maintenance costs associated with this collection of information.
Under §§ 101.9 and 101.12, some
manufacturers of retail food products
make labeling changes to modify the
serving sizes and other nutrition
information based on changes to what
products may be or are required to be
labeled as a single serving, or based on
updated, modified, or established
RACCs. We estimate that about 500 new
products will be affected by these
requirements each year and that the
associated disclosure burden is 2 hours
per product, for an annual burden of
1,000 hours. This information collection
reflects adjustments resulting from
regulations that have become effective
since last OMB review (RIN 0910–
AF22). Accordingly, we have lowered
our third-party disclosure estimate to
reflect that burden associated with
changes in labeling resulting from the
new requirements has since been
realized by respondents. This results in
a decrease of 1,149,158 annual
disclosures and 2,299,816 burden hours
attributable to those labeling changes.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: July 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Pain and Opioid use
in Hemodialysis Patients.
Date: August 6, 2019.
Time: 8:00 a.m. to 6:00 p.m.
[FR Doc. 2019–15523 Filed 7–19–19; 8:45 am]
BILLING CODE 4164–01–P
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19:11 Jul 19, 2019
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National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
PO 00000
Frm 00054
Fmt 4703
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Agenda: To review and evaluate grant
applications.
Place: Embassy Suites—Chevy Chase
Pavilion, 4300 Military Road NW,
Washington, DC 20015.
Contact Person: Ryan G. Morris, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7015, 6707 Democracy Boulevard,
Bethesda, MD 20892–2542, 301–594–4721,
ryan.morris@nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: July 16, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–15463 Filed 7–19–19; 8:45 am]
BILLING CODE 4140–01–P
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[Federal Register Volume 84, Number 140 (Monday, July 22, 2019)]
[Notices]
[Page 35121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15463]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases;
Notice of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute of Diabetes and Digestive
and Kidney Diseases Special Emphasis Panel; Pain and Opioid use in
Hemodialysis Patients.
Date: August 6, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Embassy Suites--Chevy Chase Pavilion, 4300 Military Road
NW, Washington, DC 20015.
Contact Person: Ryan G. Morris, Ph.D., Scientific Review
Officer, Review Branch, DEA, NIDDK, National Institutes of Health,
Room 7015, 6707 Democracy Boulevard, Bethesda, MD 20892-2542, 301-
594-4721, [email protected].
This notice is being published less than 15 days prior to the
meeting due to the timing limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance Program Nos. 93.847,
Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive
Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes of Health, HHS)
Dated: July 16, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-15463 Filed 7-19-19; 8:45 am]
BILLING CODE 4140-01-P
