Documenting Electronic Data Files and Statistical Analysis Programs; Guidance for Industry; Availability, 72671-72672 [2020-25131]

Download as PDF Federal Register / Vol. 85, No. 220 / Friday, November 13, 2020 / Notices The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2020–25063 Filed 11–12–20; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0052] Documenting Electronic Data Files and Statistical Analysis Programs; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #197 entitled ‘‘Documenting Electronic Data Files and Statistical Analysis Programs.’’ This guidance is intended to inform sponsors of recommendations for documenting electronic data files and statistical analyses submitted to the Center for Veterinary Medicine (CVM) to support new animal drug applications. SUMMARY: The announcement of the guidance is published in the Federal Register on November 13, 2020. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: DATES: jbell on DSKJLSW7X2PROD with NOTICES 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 VerDate Sep<11>2014 17:19 Nov 12, 2020 Jkt 253001 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): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, 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– 2009–D–0052 for ‘‘Documenting Electronic Data Files and Statistical Analysis Programs.’’ 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 Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. • 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 Dockets Management Staff. 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 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 72671 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 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the guidance to the Policy and Regulations Staff (HFV–6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Virginia Recta, Center for Veterinary Medicine (HFV–160), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–402–0840, virginia.recta@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of GFI #197 entitled ‘‘Documenting Electronic Data Files and Statistical Analysis Programs.’’ In the Federal Register of May 21, 2018 (83 FR 23468), FDA published the notice of availability for a draft guidance entitled ‘‘Documenting Electronic Data Files and Statistical Analysis Programs,’’ giving interested persons until July 20, 2018, to comment on the draft guidance. On July 20, 2018, FDA published a notice of availability announcing the extension of the comment period to October 18, 2018 (83 FR 34595). FDA received numerous comments on the draft guidance and these comments were considered as the guidance was finalized. The guidance announced in this notice finalizes the draft guidance dated May 2018. This guidance is intended to inform sponsors of recommendations for E:\FR\FM\13NON1.SGM 13NON1 72672 Federal Register / Vol. 85, No. 220 / Friday, November 13, 2020 / Notices documenting electronic data files and statistical analyses submitted to CVM to support new animal drug applications. These recommendations are intended to reduce the number of revisions that may be required for CVM to effectively review data submissions. They are also intended to simplify submission preparation for sponsors by providing a suggested documentation framework, including a sample structure on how to describe and organize the information regarding the electronic data files and statistical analysis programs. This Level I guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Documenting Electronic Data Files and Statistical Analysis Programs.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required. However, this guidance refers to previously approved collections of information. These collections of information are subject to review by OMB under the PRA (44 U.S.C. 3501– 3521). The collections of information in 21 CFR part 514 have been approved under OMB control number 0910–0032. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/animal-veterinary/ guidance-regulations/guidance-industry or https://www.regulations.gov. Dated: November 9, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–25131 Filed 11–12–20; 8:45 am] jbell on DSKJLSW7X2PROD with NOTICES BILLING CODE 4164–01–P VerDate Sep<11>2014 17:19 Nov 12, 2020 Jkt 253001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–1992] Prospective Grant of an Exclusive Patent License: Field-Deployable Mass Spectrometer Diagnostic for SARS, SARS–CoV–2 and Other Viruses, Bacteria and Bacterial Serovar, and Drug Impurities AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is contemplating the grant of an Exclusive Patent License to practice the invention embodied in the U.S. Patent listed in the Supplementary Information section of this notice to Advion, Inc. located in Ithaca, New York. DATES: Only written comments and/or applications for a license which are received by the Food and Drug Administration’s Technology Transfer Program on or before November 30, 2020 will be considered. ADDRESSES: Inquiries and comments relating to the contemplated Exclusive Patent License should be directed to: Ken Millburne, Food and Drug Administration Technology Transfer Program, Bldg. 1, Rm. 4213, Silver Spring, MD 20993, 240–478–1662; email: Kenneth.millburne@fda.hhs.gov. SUPPLEMENTARY INFORMATION: SUMMARY: Intellectual Property FDA Reference No.: E–2011–021: ‘‘Direct Impact Ionization (DII) Mass Spectrometry.’’ I. U.S. Non-Provisional Application 13/271,182, filed October 11, 2011 (FDA Reference No.: E–2011–021/US–02). II. U.S. Patent granted April 22, 2014: U.S. Patent 8,704,169 B2 (FDA Reference No. E–2011–021/U.S.–02) The patent rights in this invention have been assigned to the Government of the United States of America. The prospective exclusive license territory may be worldwide and in fields of use that may be limited to manufacture and commercialization of a field-deployable mass spectrometer diagnostic for the rapid detection of SARS, SARS–CoV–2 and other viruses, bacteria and bacterial serovar, and drug impurities. Above listed patent covers inventions directed to a mass spectrometer for analyzing samples suspected of having microorganisms. It is also directed to methods for generating a mass spectrum profile of a sample. PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing. The prospective exclusive license may be granted unless within 15 days from the date of this published notice, FDA receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404. In response to this notice, the public may file comments or objections. Comments and objections, other than those in the form of a license application, will not be treated confidentially, and may be made publicly available. License applications submitted in response to this notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552. Dated: November 9, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–25142 Filed 11–12–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request; Special Volunteer and Guest Researcher Assignment (Office of Intramural Research, Office of the Director) AGENCY: National Institutes of Health, HHS. ACTION: Notice. In compliance with the requirement of the Paperwork Reduction Act of 1995, to provide opportunity for public comment on proposed data collection projects, the Office of Intramural Research (OIR), Office of the Director (OD), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. DATES: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection SUMMARY: E:\FR\FM\13NON1.SGM 13NON1

Agencies

[Federal Register Volume 85, Number 220 (Friday, November 13, 2020)]
[Notices]
[Pages 72671-72672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25131]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0052]


Documenting Electronic Data Files and Statistical Analysis 
Programs; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry (GFI) #197 entitled 
``Documenting Electronic Data Files and Statistical Analysis 
Programs.'' This guidance is intended to inform sponsors of 
recommendations for documenting electronic data files and statistical 
analyses submitted to the Center for Veterinary Medicine (CVM) to 
support new animal drug applications.

DATES: The announcement of the guidance is published in the Federal 
Register on November 13, 2020.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time 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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2009-D-0052 for ``Documenting Electronic Data Files and Statistical 
Analysis Programs.'' 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 Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     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 Dockets Management Staff. 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 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the 
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, 
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Virginia Recta, Center for Veterinary 
Medicine (HFV-160), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0840, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of GFI #197 entitled 
``Documenting Electronic Data Files and Statistical Analysis 
Programs.'' In the Federal Register of May 21, 2018 (83 FR 23468), FDA 
published the notice of availability for a draft guidance entitled 
``Documenting Electronic Data Files and Statistical Analysis 
Programs,'' giving interested persons until July 20, 2018, to comment 
on the draft guidance. On July 20, 2018, FDA published a notice of 
availability announcing the extension of the comment period to October 
18, 2018 (83 FR 34595). FDA received numerous comments on the draft 
guidance and these comments were considered as the guidance was 
finalized. The guidance announced in this notice finalizes the draft 
guidance dated May 2018.
    This guidance is intended to inform sponsors of recommendations for

[[Page 72672]]

documenting electronic data files and statistical analyses submitted to 
CVM to support new animal drug applications. These recommendations are 
intended to reduce the number of revisions that may be required for CVM 
to effectively review data submissions. They are also intended to 
simplify submission preparation for sponsors by providing a suggested 
documentation framework, including a sample structure on how to 
describe and organize the information regarding the electronic data 
files and statistical analysis programs.
    This Level I guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the current thinking of FDA on ``Documenting Electronic Data Files and 
Statistical Analysis Programs.'' It does not establish any rights for 
any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains no collection of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required.
    However, this guidance refers to previously approved collections of 
information. These collections of information are subject to review by 
OMB under the PRA (44 U.S.C. 3501-3521). The collections of information 
in 21 CFR part 514 have been approved under OMB control number 0910-
0032.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry or https://www.regulations.gov.

    Dated: November 9, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-25131 Filed 11-12-20; 8:45 am]
BILLING CODE 4164-01-P

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