Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry; Availability, 61763-61764 [2017-28140]

Download as PDF Federal Register / Vol. 82, No. 249 / Friday, December 29, 2017 / Notices Advantage and Prescription Drug Plan organizations submit a completed PBP and formulary as part of the annual bidding process. During this process, organizations prepare their proposed plan benefit packages for the upcoming contract year and submit them to us for review and approval. We publish beneficiary education information using a variety of formats. The specific education initiatives that utilize PBP and formulary data include web application tools on www.medicare.gov and the plan benefit insert in the Medicare & You handbook. In addition, organizations utilize the PBP data to generate their Summary of Benefits marketing information. This notice replaces the 30-day Federal Register notice that published on December 13, 2017 (82 FR 58613) which was subsequently withdrawn on December 22, 2017 (82 FR 60744). Form Number: CMS–R–262 (OMB control number 0938–0763); Frequency: Yearly; Affected Public: Private sector (Business or other for-profits and Notfor-profit institutions); Number of Respondents: 520; Total Annual Responses: 5,675; Total Annual Hours: 56,450. (For policy questions regarding this collection contact Kristy Holtje at 410–786–2209.) Dated: December 26, 2017. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2017–28159 Filed 12–28–17; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–D–6530] Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.’’ This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of drug or biological ethrower on DSK3G9T082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 20:09 Dec 28, 2017 Jkt 244001 products (hereafter referred to as products). The previous guidance for industry ‘‘Formal Meetings Between the FDA and Sponsors or Applicants’’ published May 19, 2009, and the draft guidance for industry ‘‘Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products’’ published March 11, 2015, have been withdrawn. Submit either electronic or written comments on the draft guidance by March 29, 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: DATES: 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– PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 61763 2017–D–6530 for ‘‘Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry; Availability.’’ 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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 draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, E:\FR\FM\29DEN1.SGM 29DEN1 61764 Federal Register / Vol. 82, No. 249 / Friday, December 29, 2017 / Notices 4th Floor, Silver Spring, MD 20993– 0002, or Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. 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: Rachel B. Kichline, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6312, Silver Spring, MD 20993–0002, 301– 796–0319; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: ethrower on DSK3G9T082PROD with NOTICES I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.’’ This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of products regulated by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. This draft guidance does not apply to abbreviated new drug applications, applications for biosimilar biological products, or submissions for medical devices. For the purposes of this guidance, formal meeting includes any meeting that is requested by a sponsor or applicant following the request procedures provided in this guidance and includes meetings conducted in any format (i.e., face to face, teleconference/videoconference, or written response only). This guidance discusses the principles of good meeting management practices and describes standardized procedures for requesting, preparing for, scheduling, conducting, and documenting such formal meetings. The general principles in this guidance may be extended to other nonapplicationrelated meetings with external constituents, insofar as this is possible. The previous guidance for industry ‘‘Formal Meetings Between the FDA and Sponsors or Applicants’’ published May 19, 2009, and the draft guidance for industry ‘‘Formal Meetings Between the FDA and Sponsors or Applicants of VerDate Sep<11>2014 20:09 Dec 28, 2017 Jkt 244001 PDUFA Products’’ published March 11, 2015, have been withdrawn. This draft 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 formal meetings between FDA and sponsors or applicants of PDUFA products. 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. II. The Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information referred to in the guidance entitled ‘‘Formal Meetings Between the FDA and Sponsors or Applicants’’ have been approved under OMB control number 0910–0429. The collections of information for Form FDA 1571 and end-of-phase 2 meetings have been approved under OMB control number 0910–0014 and collections of information for Form FDA 356h have been approved under OMB control number 0910–0338. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/default.htm, or https:// www.regulations.gov. Dated: December 19, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–28140 Filed 12–28–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–D–6564] Best Practices for Communication Between Investigational New Drug Application Sponsors and the Food and Drug Administration; Guidance for Industry and Review Staff; Availability AGENCY: Food and Drug Administration, HHS. PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry and review staff entitled ‘‘Best Practices for Communication Between IND Sponsors and FDA During Drug Development.’’ Timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development facilitate earlier availability of safe and effective drugs to the American public. This guidance describes FDA’s philosophy regarding timely interactive communication with IND sponsors as a core activity; describes the scope of appropriate interactions between FDA review teams and IND sponsors; outlines the types of advice appropriate for sponsors to seek from FDA in pursuing their drug development programs; describes the general expectations for the timing of FDA responses to IND sponsor inquiries; describes best practices and communication methods to facilitate interactions between FDA review teams and IND sponsors during drug development; and includes expectations on appropriate methods and frequency of such communications. This guidance does not apply to communications or inquiries from industry trade organizations, consumer or patient advocacy organizations, other government agencies, or other stakeholders not pursuing a development program under an IND. This guidance finalizes the draft guidance issued on December 9, 2015. DATES: The announcement of the guidance is published in the Federal Register on December 29, 2017. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time 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 E:\FR\FM\29DEN1.SGM 29DEN1

Agencies

[Federal Register Volume 82, Number 249 (Friday, December 29, 2017)]
[Notices]
[Pages 61763-61764]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-28140]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6530]

Formal Meetings Between the Food and Drug Administration and
Sponsors or Applicants of Prescription Drug User Fee Act Products;
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 guidance for industry entitled ``Formal
Meetings Between the FDA and Sponsors or Applicants of PDUFA
Products.'' This draft guidance provides recommendations to industry on
formal meetings between FDA and sponsors or applicants relating to the
development and review of drug or biological products (hereafter
referred to as products). The previous guidance for industry ``Formal
Meetings Between the FDA and Sponsors or Applicants'' published May 19,
2009, and the draft guidance for industry ``Formal Meetings Between the
FDA and Sponsors or Applicants of PDUFA Products'' published March 11,
2015, have been withdrawn.

DATES: Submit either electronic or written comments on the draft
guidance by March 29, 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-2017-D-6530 for ``Formal Meetings Between the Food and Drug
Administration and Sponsors or Applicants of Prescription Drug User Fee
Act Products; Draft Guidance for Industry; Availability.'' 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.gpo.gov/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 draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building,

[[Page 61764]]

4th Floor, Silver Spring, MD 20993-0002, or Office of Communication,
Outreach, and Development, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 3128, Silver Spring, MD 20993-0002. 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: Rachel B. Kichline, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6312, Silver Spring, MD 20993-0002, 301-
796-0319; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry
entitled ``Formal Meetings Between the FDA and Sponsors or Applicants
of PDUFA Products.'' This draft guidance provides recommendations to
industry on formal meetings between FDA and sponsors or applicants
relating to the development and review of products regulated by the
Center for Drug Evaluation and Research and the Center for Biologics
Evaluation and Research. This draft guidance does not apply to
abbreviated new drug applications, applications for biosimilar
biological products, or submissions for medical devices. For the
purposes of this guidance, formal meeting includes any meeting that is
requested by a sponsor or applicant following the request procedures
provided in this guidance and includes meetings conducted in any format
(i.e., face to face, teleconference/videoconference, or written
response only).
This guidance discusses the principles of good meeting management
practices and describes standardized procedures for requesting,
preparing for, scheduling, conducting, and documenting such formal
meetings. The general principles in this guidance may be extended to
other nonapplication-related meetings with external constituents,
insofar as this is possible.
The previous guidance for industry ``Formal Meetings Between the
FDA and Sponsors or Applicants'' published May 19, 2009, and the draft
guidance for industry ``Formal Meetings Between the FDA and Sponsors or
Applicants of PDUFA Products'' published March 11, 2015, have been
withdrawn.
This draft 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 formal
meetings between FDA and sponsors or applicants of PDUFA products. 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.

II. The Paperwork Reduction Act of 1995

This draft guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information referred to in the guidance
entitled ``Formal Meetings Between the FDA and Sponsors or Applicants''
have been approved under OMB control number 0910-0429. The collections
of information for Form FDA 1571 and end-of-phase 2 meetings have been
approved under OMB control number 0910-0014 and collections of
information for Form FDA 356h have been approved under OMB control
number 0910-0338.

III. Electronic Access

Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.

Dated: December 19, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-28140 Filed 12-28-17; 8:45 am]
BILLING CODE 4164-01-P

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