83 FR 34595 - Documenting Electronic Data Files and Statistical Analysis Programs; Draft Guidance for Industry; Availability; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 140 (July 20, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 140 (July 20, 2018)
| Page Range | 34595-34596 | |
| FR Document | 2018-15568 |
[Federal Register Volume 83, Number 140 (Friday, July 20, 2018)] [Notices] [Pages 34595-34596] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-15568] ----------------------------------------------------------------------- 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Drug Administration [Docket No. FDA-2009-D-0052] Documenting Electronic Data Files and Statistical Analysis Programs; Draft Guidance for Industry; Availability; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability; extension of comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice of availability that published in the Federal Register on May 21, 2018. In that document, FDA requested comments on the draft revised guidance for industry (GFI) #197 entitled ``Documenting Electronic Data Files and Statistical Analysis Programs.'' The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period on the document published May 21, 2018 (83 FR 23468). Submit either electronic or written comments on the draft revised guidance by October 18, 2018, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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 [[Page 34596]] 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. 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: In the Federal Register of May 21, 2018, FDA published a notice announcing the availability of draft revised GFI #197 entitled ``Documenting Electronic Data Files and Statistical Analysis Programs'' with a 60-day comment period. We requested comments about informing 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. The Agency has received a request for a 90-day extension of the comment period. The request conveyed concern that the current 60-day comment period does not allow sufficient time to develop a comprehensive response. FDA has considered the request and is extending the comment period for the notice of availability for 90 days, until October 18, 2018. The Agency believes that a 90-day extension allows adequate time for interested persons to submit comments. Dated: July 16, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-15568 Filed 7-19-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices 34595
require that State Refugee Resettlement ORR–6 in order to participate in the Respondents: State governments,
and Wilson-Fish agencies, and local and above-mentioned programs. Replacement Designees, and Wilson/
Tribal governments complete Form Fish Alternative Projects.
ANNUAL BURDEN ESTIMATES
Number of Average
Number of responses Total burden
Instrument burden hours
respondents per hours
per response
respondent
ORR–6 Performance Report ........................................................................... 57 2 8 912
Estimated Total Annual Burden In that document, FDA requested Written/Paper Submissions
Hours: 912. comments on the draft revised guidance Submit written/paper submissions as
Copies of the proposed collection may for industry (GFI) #197 entitled follows:
be obtained by writing to the ‘‘Documenting Electronic Data Files and • Mail/Hand delivery/Courier (for
Administration for Children and Statistical Analysis Programs.’’ The written/paper submissions): Dockets
Families, Office of Planning, Research Agency is taking this action in response Management Staff (HFA–305), Food and
and Evaluation, 330 C Street SW, to a request for an extension to allow Drug Administration, 5630 Fishers
Washington, DC 20201. Attention interested persons additional time to Lane, Rm. 1061, Rockville, MD 20852.
Reports Clearance Officer. All requests submit comments. • For written/paper comments
should be identified by the title of the submitted to the Dockets Management
information collection. Email address: DATES: FDA is extending the comment Staff, FDA will post your comment, as
infocollection@acf.hhs.gov. period on the document published May well as any attachments, except for
OMB Comment: OMB is required to 21, 2018 (83 FR 23468). Submit either information submitted, marked and
make a decision concerning the electronic or written comments on the identified, as confidential, if submitted
collection of information between 30 draft revised guidance by October 18, as detailed in ‘‘Instructions.’’
and 60 days after publication of this 2018, to ensure that the Agency Instructions: All submissions received
document in the Federal Register. considers your comment on this draft must include the Docket No. FDA–
Therefore, a comment is best assured of guidance before it begins work on the 2009–D–0052 for ‘‘Documenting
having its full effect if OMB receives it final version of the guidance. Electronic Data Files and Statistical
within 30 days of publication. Written Analysis Programs.’’ Received
comments and recommendations for the ADDRESSES: You may submit comments
on any guidance at any time as follows: comments will be placed in the docket
proposed information collection should and, except for those submitted as
be sent directly to the following: Office Electronic Submissions ‘‘Confidential Submissions,’’ publicly
of Management and Budget, Paperwork viewable at https://www.regulations.gov
Reduction Project, Email: OIRA_ Submit electronic comments in the or at the Dockets Management Staff
SUBMISSION@OMB.EOP.GOV, Attn: following way: between 9 a.m. and 4 p.m., Monday
Desk Officer for the Administration for • Federal eRulemaking Portal: through Friday.
Children and Families. https://www.regulations.gov. Follow the • Confidential Submissions—To
Robert Sargis, instructions for submitting comments. submit a comment with confidential
Comments submitted electronically, information that you do not wish to be
Reports Clearance Officer.
including attachments, to https:// made publicly available, submit your
[FR Doc. 2018–15537 Filed 7–19–18; 8:45 am]
www.regulations.gov will be posted to comments only as a written/paper
BILLING CODE 4184–45–P
the docket unchanged. Because your submission. You should submit two
comment will be made public, you are copies total. One copy will include the
solely responsible for ensuring that your information you claim to be confidential
DEPARTMENT OF HEALTH AND
comment does not include any with a heading or cover note that states
HUMAN SERVICES
confidential information that you or a ‘‘THIS DOCUMENT CONTAINS
Food and Drug Administration third party may not wish to be posted, CONFIDENTIAL INFORMATION.’’ The
such as medical information, your or Agency will review this copy, including
[Docket No. FDA–2009–D–0052] the claimed confidential information, in
anyone else’s Social Security number, or
confidential business information, such its consideration of comments. The
Documenting Electronic Data Files and
second copy, which will have the
Statistical Analysis Programs; Draft as a manufacturing process. Please note
claimed confidential information
Guidance for Industry; Availability; that if you include your name, contact
redacted/blacked out, will be available
Extension of Comment Period information, or other information that
for public viewing and posted on
identifies you in the body of your
AGENCY: Food and Drug Administration, https://www.regulations.gov. Submit
comments, that information will be
HHS. both copies to the Dockets Management
posted on https://www.regulations.gov. Staff. If you do not wish your name and
ACTION:Notice of availability; extension
daltland on DSKBBV9HB2PROD with NOTICES
of comment period. • If you want to submit a comment contact information to be made publicly
with confidential information that you available, you can provide this
SUMMARY: The Food and Drug do not wish to be made available to the information on the cover sheet and not
Administration (FDA or Agency) is public, submit the comment as a in the body of your comments and you
extending the comment period for the written/paper submission and in the must identify this information as
notice of availability that published in manner detailed (see ‘‘Written/Paper ‘‘confidential.’’ Any information marked
the Federal Register on May 21, 2018. Submissions’’ and ‘‘Instructions’’). as ‘‘confidential’’ will not be disclosed
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![34596 Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices
except in accordance with 21 CFR 10.20 DEPARTMENT OF HEALTH AND third party may not wish to be posted,
and other applicable disclosure law. For HUMAN SERVICES such as medical information, your or
more information about FDA’s posting anyone else’s Social Security number, or
of comments to public dockets, see 80 Food and Drug Administration confidential business information, such
FR 56469, September 18, 2015, or access [Docket No. FDA–2008–N–0500] as a manufacturing process. Please note
the information at: https://www.gpo.gov/ that if you include your name, contact
fdsys/pkg/FR-2015-09-18/pdf/2015- Agency Information Collection information, or other information that
23389.pdf. Activities; Proposed Collection; identifies you in the body of your
Comment Request; Requirements on comments, that information will be
Docket: For access to the docket to posted on https://www.regulations.gov.
Content and Format of Labeling for
read background documents or the Human Prescription Drug and • If you want to submit a comment
electronic and written/paper comments Biological Products with confidential information that you
received, go to https:// do not wish to be made available to the
www.regulations.gov and insert the AGENCY: Food and Drug Administration, public, submit the comment as a
docket number, found in brackets in the HHS. written/paper submission and in the
heading of this document, into the ACTION: Notice. manner detailed (see ‘‘Written/Paper
‘‘Search’’ box and follow the prompts Submissions’’ and ‘‘Instructions’’).
SUMMARY: The Food and Drug
and/or go to the Dockets Management Administration (FDA or Agency) is Written/Paper Submissions
Staff, 5630 Fishers Lane, Rm. 1061, announcing an opportunity for public
Rockville, MD 20852. Submit written/paper submissions as
comment on the proposed collection of follows:
FOR FURTHER INFORMATION CONTACT: certain information by the Agency. • Mail/Hand delivery/Courier (for
Virginia Recta, Center for Veterinary Under the Paperwork Reduction Act of written/paper submissions): Dockets
Medicine (HFV–160), Food and Drug 1995 (PRA), Federal Agencies are Management Staff (HFA–305), Food and
Administration, 7500 Standish Pl., required to publish notice in the Drug Administration, 5630 Fishers
Rockville, MD 20855, 240–402–0840, Federal Register concerning each Lane, Rm. 1061, Rockville, MD 20852.
virginia.recta@fda.hhs.gov.
proposed collection of information, • For written/paper comments
including each proposed extension of an submitted to the Dockets Management
SUPPLEMENTARY INFORMATION: In the existing collection of information, and Staff, FDA will post your comment, as
Federal Register of May 21, 2018, FDA to allow 60 days for public comment in well as any attachments, except for
published a notice announcing the response to the notice. This notice information submitted, marked and
availability of draft revised GFI #197 solicits comments on the information identified, as confidential, if submitted
entitled ‘‘Documenting Electronic Data collection provisions of FDA’s as detailed in ‘‘Instructions.’’
Files and Statistical Analysis Programs’’ requirements on content and format of Instructions: All submissions received
with a 60-day comment period. We labeling for human prescription drug must include the Docket No. FDA–
requested comments about informing and biological products. 2008–N–0500 for ‘‘Agency Information
sponsors of recommendations for DATES: Submit either electronic or Collection Activities; Proposed
documenting electronic data files and written comments on the collection of Collection; Comment Request;
statistical analyses submitted to CVM to information by September 18, 2018. Requirements on Content and Format of
support new animal drug applications. ADDRESSES: You may submit comments Labeling for Human Prescription Drug
as follows. Please note that late, and Biological Products.’’ Received
These recommendations are intended to
untimely filed comments will not be comments, those filed in a timely
reduce the number of revisions that may
considered. Electronic comments must manner (see ADDRESSES), will be placed
be required for CVM to effectively
be submitted on or before September 18, in the docket and, except for those
review data submissions and to simplify submitted as ‘‘Confidential
submission preparation by providing a 2018. The https://www.regulations.gov
electronic filing system will accept Submissions,’’ publicly viewable at
recommended documentation https://www.regulations.gov or at the
comments until midnight Eastern Time
framework. Dockets Management Staff between 9
at the end of September 18, 2018.
The Agency has received a request for Comments received by mail/hand a.m. and 4 p.m., Monday through
a 90-day extension of the comment delivery/courier (for written/paper Friday.
period. The request conveyed concern submissions) will be considered timely • Confidential Submissions—To
that the current 60-day comment period if they are postmarked or the delivery submit a comment with confidential
does not allow sufficient time to service acceptance receipt is on or information that you do not wish to be
develop a comprehensive response. before that date. made publicly available, submit your
comments only as a written/paper
FDA has considered the request and Electronic Submissions submission. You should submit two
is extending the comment period for the Submit electronic comments in the copies total. One copy will include the
notice of availability for 90 days, until following way: information you claim to be confidential
October 18, 2018. The Agency believes • Federal eRulemaking Portal: with a heading or cover note that states
that a 90-day extension allows adequate https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
time for interested persons to submit instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The
comments. Comments submitted electronically, Agency will review this copy, including
daltland on DSKBBV9HB2PROD with NOTICES
Dated: July 16, 2018. including attachments, to https:// the claimed confidential information, in
Leslie Kux,
www.regulations.gov will be posted to its consideration of comments. The
the docket unchanged. Because your second copy, which will have the
Associate Commissioner for Policy.
comment will be made public, you are claimed confidential information
[FR Doc. 2018–15568 Filed 7–19–18; 8:45 am] solely responsible for ensuring that your redacted/blacked out, will be available
BILLING CODE 4164–01–P comment does not include any for public viewing and posted on
confidential information that you or a https://www.regulations.gov. Submit
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Document Created: 2018-07-20 01:18:48
Document Modified: 2018-07-20 01:18:48
| 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; extension of comment period. | |
| Dates | FDA is extending the comment period on the document published May 21, 2018 (83 FR 23468). Submit either electronic or written comments on the draft revised guidance by October 18, 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, virgi[email protected] | |
| FR Citation | 83 FR 34595 |
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