80 FR 43780 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 141 (July 23, 2015)

Page Range		43780-43780
FR Document		2015-18042

The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Federal Register, Volume 80 Issue 141 (Thursday, July 23, 2015)

[Federal Register Volume 80, Number 141 (Thursday, July 23, 2015)]
[Notices]
[Page 43780]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-18042]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0781]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Record Retention Requirements for 
the Soy Protein and Risk of Coronary Heart Disease Health Claim

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled, ``Record Retention Requirements for 
the Soy Protein and Risk of Coronary Heart Disease Health Claim'' has 
been approved by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: On June 08, 2015, the Agency submitted a 
proposed collection of information entitled, ``Record Retention 
Requirements for the Soy Protein and Risk of Coronary Heart Disease 
Health Claim'' to OMB for review and clearance under 44 U.S.C. 3507. 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. OMB has now approved the information 
collection and has assigned OMB control number 0910-0428. The approval 
expires on July 31, 2018. A copy of the supporting statement for this 
information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: July 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18042 Filed 7-22-15; 8:45 am]
 BILLING CODE 4164-01-P

43780 Federal Register / Vol. 80, No. 141 / Thursday, July 23, 2015 / Notices

ACTION:Notice of availability; request professionals, with the mission of DEPARTMENT OF HEALTH AND
for comments. providing an open, transparent, and HUMAN SERVICES
collaborative forum to address
SUMMARY: The Food and Drug computational science issues. As part of Food and Drug Administration
Administration (FDA), Center for Drug this collaboration, PhUSE working
Evaluation and Research (CDER), is groups develop and periodically publish [Docket No. FDA–2011–N–0781]
establishing a public docket to collect proposals for enhancing the review and
comments related to a proposed Study analysis of human and animal study Agency Information Collection
Data Reviewer’s Guide (SDRG) template. data submitted to regulatory agencies. Activities; Announcement of Office of
As part of FDA’s ongoing collaboration You can learn more about PhUSE Management and Budget Approval;
with the Pharmaceutical Users Software working groups at http://www.phuse.eu/
Exchange (PhUSE), an independent, Record Retention Requirements for the
cs-working-groups.aspx. Soy Protein and Risk of Coronary
non-profit consortium addressing In December 2014, FDA published the
computational science issues, a PhUSE Heart Disease Health Claim
Study Data Technical Conformance
working group developed the PhUSE Guide (the ‘‘Guide,’’ available at
SRDG template. The purpose of this AGENCY: Food and Drug Administration,
http://www.fda.gov/ForIndustry/ HHS.
review is to evaluate the template and DataStandards/StudyDataStandards/
determine whether FDA will default.htm), which contains technical ACTION: Notice.
recommend its use either as is, or in a recommendations to sponsors for the
modified form, for regulatory submission of animal and human study SUMMARY: The Food and Drug
submissions of study data. FDA is data and related information in a Administration (FDA) is announcing
seeking public comment on the use of standardized electronic format. In that a collection of information entitled,
the PhUSE SDRG template for section 2.2 of the Guide, FDA ‘‘Record Retention Requirements for the
regulatory submissions. recommends that each submitted study Soy Protein and Risk of Coronary Heart
DATES: Although you can comment on contain a Study Data Reviewer’s Guide Disease Health Claim’’ has been
the PhUSE SRDG template at any time, containing any special considerations or approved by the Office of Management
to ensure that the Agency considers directions that may facilitate review of and Budget (OMB) under the Paperwork
your comments in this review, please the study data. FDA notes in the Guide Reduction Act of 1995.
submit either electronic or written that the PhUSE SDRG template is an
comments by September 21, 2015. example of how to create an SDRG, but FOR FURTHER INFORMATION CONTACT: FDA
ADDRESSES: Submit written requests for does not specifically recommend its use. PRA Staff, Office of Operations, Food
single copies of the PhUSE SDRG FDA now intends to review the and Drug Administration, 8455
template to the Division of Drug PhUSE SDRG template, a deliverable of Colesville Rd., COLE–14526, Silver
Information, Center for Drug Evaluation the working group effort described Spring, MD 20993–0002, PRAStaff@
and Research, Food and Drug above, with the potential result that fda.hhs.gov.
Administration, 10903 New Hampshire FDA could recommend the use of the
Ave., Bldg. 51, Rm. 2201, Silver Spring, template in its current form, or in a SUPPLEMENTARY INFORMATION: On June
MD 20993–0002. Send one self- modified form, for use in the regulatory 08, 2015, the Agency submitted a
addressed adhesive label to assist that submission of study data in proposed collection of information
office in processing your requests. conformance with the Guide. FDA entitled, ‘‘Record Retention
Submit electronic comments to invites public comment on all matters Requirements for the Soy Protein and
http://www.regulations.gov. Submit regarding the use of the PhUSE SDRG Risk of Coronary Heart Disease Health
written comments to the Division of template. Interested persons may submit Claim’’ to OMB for review and clearance
Dockets Management (HFA–305), Food either electronic comments to http:// under 44 U.S.C. 3507. An Agency may
and Drug Administration, 5630 Fishers www.regulations.gov or written not conduct or sponsor, and a person is
Lane, Rm. 1061, Rockville, MD 20852. comments to the Division of Dockets not required to respond to, a collection
All comments should be identified with Management (see ADDRESSES). It is only of information unless it displays a
the docket number found in brackets in necessary to send one set of comments. currently valid OMB control number.
the heading of this document. Identify comments with the docket OMB has now approved the information
FOR FURTHER INFORMATION CONTACT:
number found in brackets in the
collection and has assigned OMB
Crystal Allard, Center for Drug heading of this document. Received
control number 0910–0428. The
Evaluation and Research, Food and comments may be seen in the Division
approval expires on July 31, 2018. A
Drug Administration, 10903 New of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and copy of the supporting statement for this
Hampshire Ave., Bldg. 21, Rm. 1518, information collection is available on
Silver Spring, MD 20993–0002, 301– will be posted to the docket at http://
www.regulations.gov. the Internet at http://www.reginfo.gov/
796–8856, crystal.allard@fda.hhs.gov. public/do/PRAMain.
SUPPLEMENTARY INFORMATION: II. Electronic Access
Dated: July 17, 2015.
I. Background The PhUSE SDRG template is
Leslie Kux,
available online at http://
FDA is a participating member of www.phusewiki.org/wiki/ Associate Commissioner for Policy.
mstockstill on DSK4VPTVN1PROD with NOTICES

PhUSE, an independent, non-profit index.php?title=Study_Data_ [FR Doc. 2015–18042 Filed 7–22–15; 8:45 am]
consortium of academic, regulatory, Reviewer’s_Guide. BILLING CODE 4164–01–P
non-profit, and private sector entities.
PhUSE provides a global platform for Dated: July 17, 2015.
the discussion of topics encompassing Leslie Kux,
the work of biostatisticians, data Associate Commissioner for Policy.
managers, statistical programmers, and [FR Doc. 2015–18027 Filed 7–22–15; 8:45 am]
e-clinical information technology BILLING CODE 4164–01–P

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Document Created: 2015-12-15 12:53:13
Document Modified: 2015-12-15 12:53:13

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 43780

80 FR 43780 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 141 (July 23, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration