Surrogate Endpoints for Clinical Trials in Kidney Transplantation; Notice of Public Workshop; Correction, 51280 [2015-20832]
Download as PDF
<![CDATA[
51280
Federal Register / Vol. 80, No. 163 / Monday, August 24, 2015 / Notices
In row 1 of table 1 we estimate the
total annual hourly burden necessary to
comply with the requirement under
section 403(y) of the FD&C Act to be
1,112 hours. Using historical A.C.
Nielson Sales Scanner Data, we estimate
the number of dietary supplement stock
keeping units for which product sales
are greater than zero to be 55,600.
Assuming that the flow of new products
is 10 percent per year, then each year
approximately 5,560 new dietary
supplement products are projected to
enter the market. Estimating that there
are 1,700 dietary supplement
manufacturers, re-packagers, re-labelers,
and holders of dietary supplements
subject to the information collection
requirement (using the figure 1,460 as
provided in our final rule of June 25,
2007 (72 FR 34752), on the ‘‘Current
Good Manufacturing Practice in
Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary
Supplements,’’ and factoring for a 2
percent annual growth rate), we
calculate an annual disclosure burden of
3.27 disclosures (labels) per firm. Last,
we expect that firms prepare the
required labeling for their products in a
manner that takes into account at one
time all information required to be
disclosed and therefore believe that less
than 0.2 hours (12 minutes) per product
label would be expended to fulfill this
requirement.
In row 2 of table 1 we estimate the
total burden associated with the
recommendation to include an
explanatory statement on dietary
supplement product labels letting
consumers know the purpose of the
domestic address or telephone number
to be 1,112 hours. Based upon our
knowledge of food and dietary
supplement labeling, we estimate it
would require less than 0.2 hours (12
minutes) per product label to include
such a statement.
Notice; correction.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in theFederal
Register of Monday, August 3, 2015 (80
FR 45999). The document announced a
public workshop entitled ‘‘Surrogate
Endpoints for Clinical Trials in Kidney
Transplantation.’’ The document was
published without the email address
and fax number in the Contact Person
section and without the option for email
or phone registration in the Registration
section. This document corrects those
errors.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Ramou Pratt, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6193, Silver Spring,
MD 20993–0002, 301–796–3928 or 301–
796–1600, FAX: 301–595–7993,
endpoints@fda.hhs.gov.
In FR Doc.
2015–18911, appearing on page 45999
in the Federal Register of Monday,
August 3, 2015, the following
corrections are made:
1. On page 45999, in the first column,
the Contact Person section is corrected
to read: ‘‘Contact Person: Ramou Pratt,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6193, Silver Spring,
MD 20993–0002, 301–796–3928 or 301–
796–1600, FAX: 301–595–7993,
endpoints@fda.hhs.gov.’’
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2015–N–0001]
2. On page 45999, in the second
column, the Registration section is
corrected to read: ‘‘Registration: Email,
fax, or phone your registration
information (including name, title, firm
name, address, telephone and fax
numbers) to Ramou Pratt (see Contact
Person) by September 25, 2015.
Registration is free for the public
workshop. Early registration is
recommended because seating is
limited. Registration on the day of the
public workshop will be provided on a
space-available basis beginning at 8 a.m.
If you need special accommodations
because of a disability, please contact
Ramou Pratt (see Contact Person) at
least 7 days in advance.’’
Surrogate Endpoints for Clinical Trials
in Kidney Transplantation; Notice of
Public Workshop; Correction
Dated: August 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
Dated: August 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–20760 Filed 8–21–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
tkelley on DSK3SPTVN1PROD with NOTICES
ACTION:
[FR Doc. 2015–20832 Filed 8–21–15; 8:45 am]
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
16:48 Aug 21, 2015
Jkt 235001
BILLING CODE 4164–01–P
PO 00000
Frm 00085
Fmt 4703
Sfmt 4703
[Document Identifier: OS–0990–0302–60D]
Agency Information Collection
Request. 60-Day Public Comment
Request
AGENCY:
Office of the Secretary, HHS.
Agency Information Collection Request.
60-Day Public Comment Request
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Office of the Secretary (OS), Department
of Health and Human Services, is
publishing the following summary of a
proposed information collection request
for public comment. Interested persons
are invited to send comments regarding
this burden estimate or any other aspect
of this collection of information,
including any of the following subjects:
(1) The necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions; (2) the accuracy of the
estimated burden; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden. To obtain copies of
the supporting statement and any
related forms for the proposed
paperwork collections referenced above,
email your request, including your
address, phone number, OMB number,
and OS document identifier, to
Sherette.funncoleman@hhs.gov, or call
the Reports Clearance Office on (202)
690–6162. Written comments and
recommendations for the proposed
information collections must be directed
to the OS Paperwork Clearance Officer
at the above email address within 60days.
Proposed Project: Medical Reserve
Corps Unit Profile and Reports
(Revision)—OMB No. 0990–0302—
Office of the Secretary/Office of the
Assistant Secretary for Health/Office of
the Surgeon General/Division of
Civilian Volunteer Medical Reserve
Corps (OS/OASH/OSG/DCVMRC) is
changed to Office of the Secretary/Office
of the Assistant Secretary for
Preparedness and Response/Office of
Emergency Management/Division of the
Civilian Volunteer Medical Reserve
Corps this reorganization was effective
as of 26 November 2014 as published in
the Federal Register [FR Doc. 2014–
28030 Filed 11–25–14; 8:45am].
Abstract: Medical Reserve Corps units
are currently located in almost 1,000
communities across the United States,
E:\FR\FM\24AUN1.SGM
24AUN1
]]>Agencies
[Federal Register Volume 80, Number 163 (Monday, August 24, 2015)]
[Notices]
[Page 51280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20832]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Surrogate Endpoints for Clinical Trials in Kidney
Transplantation; Notice of Public Workshop; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in theFederal Register of Monday, August 3, 2015 (80 FR
45999). The document announced a public workshop entitled ``Surrogate
Endpoints for Clinical Trials in Kidney Transplantation.'' The document
was published without the email address and fax number in the Contact
Person section and without the option for email or phone registration
in the Registration section. This document corrects those errors.
FOR FURTHER INFORMATION CONTACT: Ramou Pratt, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6193, Silver Spring, MD 20993-0002, 301-
796-3928 or 301-796-1600, FAX: 301-595-7993, endpoints@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In FR Doc. 2015-18911, appearing on page
45999 in the Federal Register of Monday, August 3, 2015, the following
corrections are made:
1. On page 45999, in the first column, the Contact Person section
is corrected to read: ``Contact Person: Ramou Pratt, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6193, Silver Spring, MD 20993-0002, 301-
796-3928 or 301-796-1600, FAX: 301-595-7993, endpoints@fda.hhs.gov.''
2. On page 45999, in the second column, the Registration section is
corrected to read: ``Registration: Email, fax, or phone your
registration information (including name, title, firm name, address,
telephone and fax numbers) to Ramou Pratt (see Contact Person) by
September 25, 2015. Registration is free for the public workshop. Early
registration is recommended because seating is limited. Registration on
the day of the public workshop will be provided on a space-available
basis beginning at 8 a.m.
If you need special accommodations because of a disability, please
contact Ramou Pratt (see Contact Person) at least 7 days in advance.''
Dated: August 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20832 Filed 8-21-15; 8:45 am]
BILLING CODE 4164-01-P
