Intent to Review a Nonclinical Study Data Reviewer's Guide Template, 11575-11576 [2016-04791]

Download as PDF Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration [Docket No. FDA–2016–N–0701] [Docket No. FDA–2012–N–0386] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: On July 29, 2015, the Agency submitted a proposed collection of information entitled ‘‘Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products’’ 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 0910–0650. The approval expires on January 31, 2019. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. jstallworth on DSK7TPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: Dated: February 29, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–04703 Filed 3–3–16; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 15:22 Mar 03, 2016 Jkt 238001 Intent to Review a Nonclinical Study Data Reviewer’s Guide Template AGENCY: Food and Drug Administration, HHS. Notice of availability; request for comments. ACTION: 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: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 https://www.regulations.gov. PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 11575 • 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 https://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 https:// 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 E:\FR\FM\04MRN1.SGM 04MRN1 11576 Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Notices 56469, September 18, 2015, or access the information at: https://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 https:// 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, crystal.allard@fda.hhs.gov. SUPPLEMENTARY INFORMATION: jstallworth on DSK7TPTVN1PROD with NOTICES 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 https://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 https:// 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 VerDate Sep<11>2014 15:22 Mar 03, 2016 Jkt 238001 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 https:// 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–3287] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Small Business Qualification and Certification AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by April 4, 2016. SUMMARY: To ensure that comments on the information collection are received, ADDRESSES: PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0508 and title ‘‘Medical Device User Fee Small Business Qualification and Certification.’’ Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Medical Device User Fee Small Business Qualification and Certification OMB Control Number 0910–0508— Extension Section 101 of the Medical Device User Fee and Modernization Act (MDUFMA) (Pub. L. 107–250) amends the Federal Food, Drug, and Cosmetic Act, to provide for user fees for certain medical device applications. FDA published a Federal Register notice on August 3, 2015 (80 FR 46033), announcing fees for fiscal year (FY) 2016. To avoid harming small businesses, MDUFMA provides for reduced or waived fees for applicants who qualify as a small business. This means there are two levels of fees; a standard fee and a reduced or waived small business fee. You can qualify for a small business fee discount under MDUFMA if you reported gross receipts or sales of no more than $100 million on your Federal income tax return for the most recent tax year. If you have any affiliates, partners, or parent firms, you must add their gross receipts or sales to yours, and the total must be no more than $100 million. If your gross receipts or sales are no more than $30 million, including all of your affiliates, partners, and parent firms, you will also qualify for a waiver of the fee for your first (ever) premarket application (product development protocol, biologics licensing application, or premarket report). An applicant must pay the full standard fee unless it provides evidence demonstrating to FDA that it meets the small business criteria (Form FDA 3602, ‘‘FY 2016 MDUFMA Small Business Qualification Certification—For a Business Headquartered in the United E:\FR\FM\04MRN1.SGM 04MRN1

Agencies

[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)]
[Notices]
[Pages 11575-11576]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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 https://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 https://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: https://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 https://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, crystal.allard@fda.hhs.gov.

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 https://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 https://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 https://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
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