81 FR 11575 - Intent to Review a Nonclinical Study Data Reviewer's Guide Template
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 43 (March 4, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 43 (March 4, 2016)
| Page Range | 11575-11576 | |
| FR Document | 2016-04791 |
[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)] [Notices] [Pages 11575-11576] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-04791] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0701] Intent to Review a Nonclinical Study Data Reviewer's Guide Template AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is establishing a public docket to collect comments related to a proposed Nonclinical Study Data Reviewer's Guide (SDRG) template. As part of FDA's ongoing collaboration with the Pharmaceutical Users Software Exchange (PhUSE), an independent, non-profit consortium addressing computational science issues, a PhUSE working group developed the PhUSE Nonclinical SRDG template. The purpose of this review is to evaluate the template and determine whether FDA will recommend its use either as is, or in a modified form, for regulatory submissions of nonclinical study data. FDA is seeking public comment on the use of the PhUSE Nonclinical SDRG template for regulatory submissions. DATES: Although you can comment on the PhUSE Nonclinical SRDG template at any time, to ensure that the Agency considers your comments in this review, please submit either electronic or written comments by May 3, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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-N-0701 for ``Intent to Review a Nonclinical Study Data Reviewer's Guide Template.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://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 http://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 [[Page 11576]] 56469, September 18, 2015, or access the information at: http://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 http://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. FOR FURTHER INFORMATION CONTACT: Crystal Allard, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 1518, Silver Spring, MD 20993-0002, 301- 796-8856, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is a participating member of PhUSE, an independent, non-profit consortium of academic, regulatory, non-profit, and private sector entities. PhUSE provides a global platform for the discussion of topics encompassing the work of biostatisticians, data managers, statistical programmers, and e-clinical information technology professionals, with the mission of providing an open, transparent, and collaborative forum to address computational science issues. As part of this collaboration, PhUSE working groups develop and periodically publish proposals for enhancing the review and analysis of human and animal study data submitted to regulatory agencies. You can learn more about PhUSE working groups at http://www.phuse.eu/cs-working-groups.aspx. (FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.) In December 2014, FDA published the Study Data Technical Conformance Guide (the ``Guide,'' available at http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm), which contains technical recommendations to sponsors for the submission of animal and human study data and related information in a standardized electronic format. In section 2.2 of the Guide, FDA recommends that each submitted study contain a Study Data Reviewer's Guide containing any special considerations or directions that may facilitate review of the study data. FDA notes in the Guide that the PhUSE SDRG template is an example of how to create an SDRG but does not specifically recommend its use. Although the Guide does not specify specific SDRGs for clinical and nonclinical studies, PhUSE project groups have created separate clinical and nonclinical studies templates. This notice applies specifically to the nonclinical SDRG template. A separate notice was issued for the clinical SDRG template in July 2015 (see ``Intent to Review a Study Data Reviewer's Guide Template'' (80 FR 43779, July 23, 2015)). FDA now intends to review the PhUSE Nonclinical SDRG template, a deliverable of the working group effort described previously in this document, with the potential result that FDA could recommend the use of the template in its current form, or in a modified form, for use in the regulatory submission of study data in conformance with the Guide. FDA invites public comment on all matters regarding the use of the PhUSE Nonclinical SDRG template. II. Electronic Access The PhUSE Nonclinical SDRG template is available at http://www.phusewiki.org/wiki/index.php?title=Study_Data_Reviewer's_Guide. Dated: February 29, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-04791 Filed 3-3-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Notices 11575
DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND • If you want to submit a comment
HUMAN SERVICES HUMAN SERVICES with confidential information that you
do not wish to be made available to the
Food and Drug Administration Food and Drug Administration public, submit the comment as a
[Docket No. FDA–2016–N–0701] written/paper submission and in the
[Docket No. FDA–2012–N–0386] manner detailed (see ‘‘Written/Paper
Intent to Review a Nonclinical Study Submissions’’ and ‘‘Instructions’’).
Agency Information Collection Data Reviewer’s Guide Template Written/Paper Submissions
Activities; Announcement of Office of AGENCY: Food and Drug Administration, Submit written/paper submissions as
Management and Budget Approval; HHS. follows:
Registration and Product Listing for • Mail/Hand delivery/Courier (for
ACTION:Notice of availability; request
Owners and Operators of Domestic written/paper submissions): Division of
for comments.
Tobacco Product Establishments and Dockets Management (HFA–305), Food
Listing of Ingredients in Tobacco SUMMARY: The Food and Drug and Drug Administration, 5630 Fishers
Products Administration (FDA), Center for Drug Lane, Rm. 1061, Rockville, MD 20852.
Evaluation and Research (CDER), is • For written/paper comments
AGENCY: Food and Drug Administration, establishing a public docket to collect submitted to the Division of Dockets
HHS. comments related to a proposed Management, FDA will post your
Nonclinical Study Data Reviewer’s comment, as well as any attachments,
ACTION: Notice.
Guide (SDRG) template. As part of except for information submitted,
FDA’s ongoing collaboration with the marked and identified, as confidential,
SUMMARY: The Food and Drug Pharmaceutical Users Software if submitted as detailed in
Administration (FDA) is announcing Exchange (PhUSE), an independent, ‘‘Instructions.’’
that a collection of information entitled non-profit consortium addressing Instructions: All submissions received
‘‘Registration and Product Listing for computational science issues, a PhUSE must include the Docket No. FDA–
Owners and Operators of Domestic working group developed the PhUSE 2016–N–0701 for ‘‘Intent to Review a
Tobacco Product Establishments and Nonclinical SRDG template. The Nonclinical Study Data Reviewer’s
Listing of Ingredients in Tobacco purpose of this review is to evaluate the Guide Template.’’ Received comments
Products’’ has been approved by the template and determine whether FDA will be placed in the docket and, except
Office of Management and Budget will recommend its use either as is, or for those submitted as ‘‘Confidential
(OMB) under the Paperwork Reduction in a modified form, for regulatory Submissions,’’ publicly viewable at
Act of 1995. submissions of nonclinical study data. http://www.regulations.gov or at the
FDA is seeking public comment on the Division of Dockets Management
FOR FURTHER INFORMATION CONTACT: FDA
use of the PhUSE Nonclinical SDRG between 9 a.m. and 4 p.m., Monday
PRA Staff, Office of Operations, Food template for regulatory submissions. through Friday.
and Drug Administration, 8455 • Confidential Submissions—To
DATES: Although you can comment on
Colesville Rd., COLE–14526, Silver submit a comment with confidential
the PhUSE Nonclinical SRDG template
Spring, MD 20993–0002, PRAStaff@ information that you do not wish to be
at any time, to ensure that the Agency
fda.hhs.gov. made publicly available, submit your
considers your comments in this review,
SUPPLEMENTARY INFORMATION: On July please submit either electronic or comments only as a written/paper
written comments by May 3, 2016. submission. You should submit two
29, 2015, the Agency submitted a
ADDRESSES: You may submit comments copies total. One copy will include the
proposed collection of information
as follows: information you claim to be confidential
entitled ‘‘Registration and Product
with a heading or cover note that states
Listing for Owners and Operators of Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
Domestic Tobacco Product CONFIDENTIAL INFORMATION.’’ The
Submit electronic comments in the
Establishments and Listing of Agency will review this copy, including
following way:
Ingredients in Tobacco Products’’ to • Federal eRulemaking Portal: http:// the claimed confidential information, in
OMB for review and clearance under 44 www.regulations.gov. Follow the its consideration of comments. The
U.S.C. 3507. An Agency may not instructions for submitting comments. second copy, which will have the
conduct or sponsor, and a person is not Comments submitted electronically, claimed confidential information
required to respond to, a collection of including attachments, to http:// redacted/blacked out, will be available
information unless it displays a www.regulations.gov will be posted to for public viewing and posted on http://
currently valid OMB control number. the docket unchanged. Because your www.regulations.gov. Submit both
OMB has now approved the information comment will be made public, you are copies to the Division of Dockets
collection and has assigned OMB solely responsible for ensuring that your Management. If you do not wish your
control number 0910–0650. The comment does not include any name and contact information to be
approval expires on January 31, 2019. A confidential information that you or a made publicly available, you can
copy of the supporting statement for this third party may not wish to be posted, provide this information on the cover
information collection is available on such as medical information, your or sheet and not in the body of your
the Internet at http://www.reginfo.gov/ anyone else’s Social Security number, or comments and you must identify this
jstallworth on DSK7TPTVN1PROD with NOTICES
public/do/PRAMain. confidential business information, such information as ‘‘confidential.’’ Any
Dated: February 29, 2016. as a manufacturing process. Please note information marked as ‘‘confidential’’
that if you include your name, contact will not be disclosed except in
Leslie Kux,
information, or other information that accordance with 21 CFR 10.20 and other
Associate Commissioner for Policy. identifies you in the body of your applicable disclosure law. For more
[FR Doc. 2016–04703 Filed 3–3–16; 8:45 am] comments, that information will be information about FDA’s posting of
BILLING CODE 4164–01–P posted on http://www.regulations.gov. comments to public dockets, see 80 FR
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![11576 Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Notices
56469, September 18, 2015, or access does not specifically recommend its use. OMB recommends that written
the information at: http://www.fda.gov/ Although the Guide does not specify comments be faxed to the Office of
regulatoryinformation/dockets/ specific SDRGs for clinical and Information and Regulatory Affairs,
default.htm. nonclinical studies, PhUSE project OMB, Attn: FDA Desk Officer, FAX:
Docket: For access to the docket to groups have created separate clinical 202–395–7285, or emailed to oira_
read background documents or the and nonclinical studies templates. This submission@omb.eop.gov. All
electronic and written/paper comments notice applies specifically to the comments should be identified with the
received, go to http:// nonclinical SDRG template. A separate OMB control number 0910–0508 and
www.regulations.gov and insert the notice was issued for the clinical SDRG title ‘‘Medical Device User Fee Small
docket number, found in brackets in the template in July 2015 (see ‘‘Intent to Business Qualification and
heading of this document, into the Review a Study Data Reviewer’s Guide Certification.’’ Also include the FDA
‘‘Search’’ box and follow the prompts Template’’ (80 FR 43779, July 23, docket number found in brackets in the
and/or go to the Division of Dockets 2015)). heading of this document.
Management, 5630 Fishers Lane, Rm. FDA now intends to review the FOR FURTHER INFORMATION CONTACT: FDA
1061, Rockville, MD 20852. PhUSE Nonclinical SDRG template, a PRA Staff, Office of Operations, Food
FOR FURTHER INFORMATION CONTACT: deliverable of the working group effort and Drug Administration, 8455
Crystal Allard, Center for Drug described previously in this document, Colesville Rd., COLE–14526, Silver
Evaluation and Research, Food and with the potential result that FDA could Spring, MD 20993–0002, PRAStaff@
Drug Administration, 10903 New recommend the use of the template in fda.hhs.gov.
Hampshire Ave., Bldg. 21, Rm. 1518, its current form, or in a modified form, SUPPLEMENTARY INFORMATION: In
Silver Spring, MD 20993–0002, 301– for use in the regulatory submission of compliance with 44 U.S.C. 3507, FDA
796–8856, crystal.allard@fda.hhs.gov. study data in conformance with the has submitted the following proposed
SUPPLEMENTARY INFORMATION:
Guide. FDA invites public comment on collection of information to OMB for
all matters regarding the use of the review and clearance.
I. Background PhUSE Nonclinical SDRG template.
Medical Device User Fee Small
FDA is a participating member of II. Electronic Access Business Qualification and Certification
PhUSE, an independent, non-profit
consortium of academic, regulatory, The PhUSE Nonclinical SDRG OMB Control Number 0910–0508—
non-profit, and private sector entities. template is available at http:// Extension
PhUSE provides a global platform for www.phusewiki.org/wiki/
index.php?title=Study_Data_ Section 101 of the Medical Device
the discussion of topics encompassing User Fee and Modernization Act
the work of biostatisticians, data Reviewer’s_Guide.
(MDUFMA) (Pub. L. 107–250) amends
managers, statistical programmers, and Dated: February 29, 2016. the Federal Food, Drug, and Cosmetic
e-clinical information technology Leslie Kux, Act, to provide for user fees for certain
professionals, with the mission of Associate Commissioner for Policy. medical device applications. FDA
providing an open, transparent, and [FR Doc. 2016–04791 Filed 3–3–16; 8:45 am] published a Federal Register notice on
collaborative forum to address BILLING CODE 4164–01–P August 3, 2015 (80 FR 46033),
computational science issues. As part of announcing fees for fiscal year (FY)
this collaboration, PhUSE working 2016. To avoid harming small
groups develop and periodically publish DEPARTMENT OF HEALTH AND businesses, MDUFMA provides for
proposals for enhancing the review and HUMAN SERVICES reduced or waived fees for applicants
analysis of human and animal study who qualify as a small business. This
data submitted to regulatory agencies. Food and Drug Administration means there are two levels of fees; a
You can learn more about PhUSE [Docket No. FDA–2015–N–3287] standard fee and a reduced or waived
working groups at http://www.phuse.eu/ small business fee. You can qualify for
cs-working-groups.aspx. (FDA has Agency Information Collection a small business fee discount under
verified the Web site addresses, as of the Activities; Submission for Office of MDUFMA if you reported gross receipts
date this document publishes in the Management and Budget Review; or sales of no more than $100 million
Federal Register, but Web sites are Comment Request; Medical Device on your Federal income tax return for
subject to change over time.) User Fee Small Business Qualification the most recent tax year. If you have any
In December 2014, FDA published the and Certification affiliates, partners, or parent firms, you
Study Data Technical Conformance must add their gross receipts or sales to
Guide (the ‘‘Guide,’’ available at http:// AGENCY: Food and Drug Administration, yours, and the total must be no more
www.fda.gov/ForIndustry/ HHS. than $100 million. If your gross receipts
DataStandards/StudyDataStandards/ ACTION: Notice of availability. or sales are no more than $30 million,
default.htm), which contains technical including all of your affiliates, partners,
SUMMARY: The Food and Drug
recommendations to sponsors for the and parent firms, you will also qualify
Administration (FDA) is announcing
submission of animal and human study for a waiver of the fee for your first
that a proposed collection of
data and related information in a (ever) premarket application (product
information has been submitted to the
standardized electronic format. In development protocol, biologics
Office of Management and Budget
section 2.2 of the Guide, FDA licensing application, or premarket
jstallworth on DSK7TPTVN1PROD with NOTICES
(OMB) for review and clearance under
recommends that each submitted study report). An applicant must pay the full
the Paperwork Reduction Act of 1995.
contain a Study Data Reviewer’s Guide standard fee unless it provides evidence
containing any special considerations or DATES: Fax written comments on the demonstrating to FDA that it meets the
directions that may facilitate review of collection of information by April 4, small business criteria (Form FDA 3602,
the study data. FDA notes in the Guide 2016. ‘‘FY 2016 MDUFMA Small Business
that the PhUSE SDRG template is an ADDRESSES: To ensure that comments on Qualification Certification—For a
example of how to create an SDRG but the information collection are received, Business Headquartered in the United
VerDate Sep<11>2014 15:22 Mar 03, 2016 Jkt 238001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\04MRN1.SGM 04MRN1](https://thefederalregister.org/doc/81_FR_11618/page/2.svg)
Document Created: 2018-02-02 15:05:47
Document Modified: 2018-02-02 15:05:47
| 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 of availability; request for comments. | |
| Dates | Although you can comment on the PhUSE Nonclinical SRDG template at any time, to ensure that the Agency considers your comments in this review, please submit either electronic or written comments by May 3, 2016. | |
| Contact | Crystal Allard, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 1518, Silver Spring, MD 20993-0002, 301- 796-8856, [email protected] | |
| FR Citation | 81 FR 11575 |
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