83 FR 23468 - Documenting Electronic Data Files and Statistical Analysis Programs; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 98 (May 21, 2018)

Page Range		23468-23469
FR Document		2018-10722

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft revised guidance for industry (GFI) #197 entitled ``Documenting Electronic Data Files and Statistical Analysis Programs.'' This draft revised guidance is provided 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.

Federal Register, Volume 83 Issue 98 (Monday, May 21, 2018)

[Federal Register Volume 83, Number 98 (Monday, May 21, 2018)]
[Notices]
[Pages 23468-23469]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-10722]

[[Page 23468]]

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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Programs; Draft Guidance for Industry; Availability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 draft revised guidance for industry (GFI) #197
entitled ``Documenting Electronic Data Files and Statistical Analysis
Programs.'' This draft revised guidance is provided 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: Submit either electronic or written comments on the draft
revised guidance by July 20, 2018 to ensure that the Agency considers
your comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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.
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.thefederalregister.org/fdsys/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.
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 draft 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 a draft revised GFI #197
entitled ``Documenting Electronic Data Files and Statistical Analysis
Programs.'' This draft revised guidance is provided to inform sponsors
of recommendations for 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 and to simplify submission preparation by providing a
recommended documentation framework.

II. Significance of Guidance

This level 1 draft revised guidance is being issued consistent with
FDA's good guidance practices regulation (21 CFR 10.115). The draft
guidance, when finalized, will represent 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.
This guidance is not subject to Executive Order 12866.

III. Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and

[[Page 23469]]

Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 514 have been
approved under OMB control number 0910-0032.

IV. Electronic Access

Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or
https://www.regulations.gov.

Dated: May 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10722 Filed 5-18-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 98 / Monday, May 21, 2018 / Notices 23469

Budget (OMB) under the Paperwork conviction and sentenced Holloway to Holloway was afforded an opportunity
Reduction Act of 1995 (44 U.S.C. 3501– probation. The basis for the conviction to submit evidence and arguments in
3520). The collections of information in was Holloway’s involvement in opposition. ORA submitted its response
21 CFR part 514 have been approved Pharmacia’s introduction into interstate on August 30, 2013. Holloway, through
under OMB control number 0910–0032. commerce of its drug BEXTRA, a pain counsel, replied to ORA’s response on
reliever and anti-inflammatory, for the November 15, 2013.
IV. Electronic Access unapproved use of treating pre- and Under § 12.26 (21 CFR 12.26), if FDA
Persons with access to the internet postoperative surgical pain. Before it determines upon review of a request for
may obtain the draft guidance at either was removed from the market several hearing that the order at issue should be
https://www.fda.gov/AnimalVeterinary/ years later, BEXTRA was only approved modified or revoked, FDA may modify
GuidanceComplianceEnforcement/ for treatment of arthritis and primary or revoke the order by notice in the
GuidanceforIndustry/default.htm or dysmenorrhea. In September 2009, Federal Register. Based upon a review
https://www.regulations.gov. Pharmacia pled guilty to a felony of the record, the Acting Chief Scientist
Dated: May 15, 2018. violation of the FD&C Act for the concludes that it is appropriate under
promotion of BEXTRA and other drugs § 12.26, in this instance, to revoke the
Leslie Kux,
for unapproved uses. proposed order to debar Holloway for 5
Associate Commissioner for Policy.
By letter dated January 20, 2010, years.
[FR Doc. 2018–10722 Filed 5–18–18; 8:45 am] FDA’s Office of Regulatory Affairs
II. Arguments
BILLING CODE 4164–01–P (ORA) notified Holloway of a proposal
to debar her for 5 years from providing In the proposal to debar Holloway for
services in any capacity to a person 5 years, ORA noted that there are four
DEPARTMENT OF HEALTH AND having an approved or pending drug applicable considerations for
HUMAN SERVICES product application. The proposal determining the appropriateness and
stated that Holloway is subject to period of Holloway’s debarment under
Food and Drug Administration section 306(c)(3) of the FD&C Act: (1)
permissive debarment based on a
[Docket No. FDA–2009–N–0361] finding, under section 306(b)(2)(B)(i) of The nature and seriousness of her
the FD&C Act (21 U.S.C. offense under section 306(c)(3)(A); (2)
Mary C. Holloway; Order Revoking a 335a(b)(2)(B)(i)), that she was convicted the nature and extent of management
Proposed Order of Debarment of a misdemeanor under Federal law for participation in the offense under
conduct relating to the regulation of a section 306(c)(3)(B); (3) the nature and
AGENCY: Food and Drug Administration,
drug product and that the type of extent of voluntary steps taken to
HHS.
conduct serving as the basis for the mitigate the impact on the public under
ACTION: Notice. section 306(c)(3)(C); and (4) prior
conviction undermines the process for
SUMMARY: The Food and Drug the regulation of drugs. The proposal convictions involving matters within
Administration (FDA) is revoking a further concluded that Holloway should the jurisdiction of FDA under section
proposed order, under the Federal Food, be debarred for the maximum period of 306(c)(3)(F). ORA found that the first
Drug, and Cosmetic Act (FD&C Act), to 5 years under section 306(c)(2)(A)(iii) of three of those considerations weigh in
the FD&C Act based on four applicable favor of debarment and noted, as to the
debar Mary C. Holloway (Holloway) for
considerations in section 306(c)(3). fourth consideration, that FDA is
5 years from providing services in any
In a letter dated February 18, 2010, unaware of any prior convictions. In
capacity to a person that has an
through counsel, Holloway requested a finding that the each of the first three
approved or pending drug product
hearing on the proposal. On March 24, considerations weighs in favor of
application. Holloway, through counsel,
2010, Holloway submitted materials and debarment, ORA appears to have
filed a request for a hearing, as well as
arguments in support of her request. In characterized Holloway’s conduct based
information and analysis in support of
her submissions, Holloway on contested allegations from
that request, in response to the proposed
acknowledged her conviction of a Holloway’s criminal proceedings.
debarment order. FDA has determined Holloway challenged both ORA’s
that pursuing debarment of Holloway is misdemeanor under Federal law.
Holloway conceded that she is subject conclusions with respect to all three
no longer appropriate. considerations in dispute and the
to debarment as a result of this
DATES: This order is applicable May 21, conviction, but she argues nonetheless factual underpinnings of those
2018. that she is entitled to a hearing to conclusions. Holloway contended that,
FOR FURTHER INFORMATION CONTACT: determine whether permissive under section 306(i) of the FD&C Act,
Nathan Sabel, Office of Scientific debarment is appropriate. Specifically, FDA may not take any action under
Integrity, Food and Drug Holloway argued that, with respect to sections 306(b) or section 306(c) with
Administration, 10903 New Hampshire the considerations for determining the respect to any person ‘‘unless [FDA] has
Ave., Bldg. 1, Rm. 4206, Silver Spring, appropriateness and period of issued an order for such action made on
MD 20993, 301–796–8588. debarment under section 306(c)(3) of the the record after opportunity for an
SUPPLEMENTARY INFORMATION: FD&C Act, there are genuine and agency hearing on disputed issues of
substantial issues of fact for resolution material fact.’’ Section 306(c)(3)
I. Background at a hearing. explicitly requires that FDA consider,
On April 8, 2009, Holloway, formerly By letter dated April 3, 2013, the ‘‘where applicable,’’ certain factors ‘‘[i]n
a regional sales manager at Pharmacia & Office of the Commissioner, in order to
sradovich on DSK3GMQ082PROD with NOTICES

determining the appropriateness and the
Upjohn Company, Inc. (Pharmacia), determine whether granting a hearing period of debarment’’ for any permissive
pled guilty to a Federal misdemeanor would be appropriate, requested that debarment.
offense under sections 301(a), 303(a)(1), ORA submit a response to Holloway’s In proposing to debar Holloway for 5
and 502(f) of the FD&C Act (21 U.S.C. request for a hearing. ORA was invited years, ORA appears to have based its
331(a), 333(a)(1), and 352(f)). In June to include any documentary evidence, findings with respect to certain
2009, the U. S. District Court for the information, or analysis that it deemed considerations in section 306(c)(3) of
District of Massachusetts entered the appropriate in support of its response. the FD&C Act largely on the factual

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Document Created: 2018-11-02 11:07:34
Document Modified: 2018-11-02 11:07:34

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.
Dates		Submit either electronic or written comments on the draft revised guidance by July 20, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Contact		Virginia Recta, Center for Veterinary Medicine (HFV-160), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0840, [email protected]
FR Citation		83 FR 23468

83 FR 23468 - Documenting Electronic Data Files and Statistical Analysis Programs; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 98 (May 21, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration