82_FR_40170 82 FR 40008 - Determination of Regulatory Review Period for Purposes of Patent Extension; RECUVYRA; Affirmation

82 FR 40008 - Determination of Regulatory Review Period for Purposes of Patent Extension; RECUVYRA; Affirmation

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 162 (August 23, 2017)

Page Range40008-40008
FR Document2017-17961

Federal Register, Volume 82 Issue 162 (Wednesday, August 23, 2017)
[Federal Register Volume 82, Number 162 (Wednesday, August 23, 2017)]
[Notices]
[Page 40008]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-17961]



[[Page 40008]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2013-E-0264; FDA-2013-E-0263; and FDA-2013-E-0218]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; RECUVYRA; Affirmation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of affirmation.

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

DATES: August 23, 2017

FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy, 10903 
New Hampshire Ave., Bldg. 51, Silver Spring, MD 20993, 301-796-9148.

SUPPLEMENTARY INFORMATION: The Food and Drug Administration (FDA) is 
affirming the signature date for a notice that appeared in the Federal 
Register on August 21, 2017 (82 FR 39587). The document announced FDA's 
determination for the regulatory review period for RECUVYRA. The 
document published with an incorrect date for the signature. We affirm 
that the document was signed on August 15, 2017.

    Dated: August 21, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17961 Filed 8-21-17; 4:15 pm]
BILLING CODE 4164-01-P



                                                    40008                      Federal Register / Vol. 82, No. 162 / Wednesday, August 23, 2017 / Notices

                                                    DEPARTMENT OF HEALTH AND                                ADDRESSES:   You may submit either                    copies total. One copy will include the
                                                    HUMAN SERVICES                                          electronic or written comments on                     information you claim to be confidential
                                                                                                            Agency guidances at any time as                       with a heading or cover note that states
                                                    Food and Drug Administration                            follows:                                              ‘‘THIS DOCUMENT CONTAINS
                                                    [Docket Nos. FDA–2013–E–0264; FDA–                                                                            CONFIDENTIAL INFORMATION.’’ The
                                                                                                            Electronic Submissions
                                                    2013–E–0263; and FDA–2013–E–0218]                                                                             Agency will review this copy, including
                                                                                                              Submit electronic comments in the                   the claimed confidential information, in
                                                    Determination of Regulatory Review                      following way:                                        its consideration of comments. The
                                                    Period for Purposes of Patent                             • Federal eRulemaking Portal:                       second copy, which will have the
                                                    Extension; RECUVYRA; Affirmation                        https://www.regulations.gov. Follow the               claimed confidential information
                                                                                                            instructions for submitting comments.                 redacted/blacked out, will be available
                                                    AGENCY:    Food and Drug Administration,                Comments submitted electronically,                    for public viewing and posted on
                                                    HHS.                                                    including attachments, to https://                    https://www.regulations.gov. Submit
                                                    ACTION:   Notification of affirmation.                  www.regulations.gov will be posted to                 both copies to the Dockets Management
                                                                                                            the docket unchanged. Because your                    Staff. If you do not wish your name and
                                                    DATES:   August 23, 2017                                comment will be made public, you are                  contact information to be made publicly
                                                    FOR FURTHER INFORMATION CONTACT:                        solely responsible for ensuring that your             available, you can provide this
                                                    Joyce Strong, Office of Policy, 10903                   comment does not include any                          information on the cover sheet and not
                                                    New Hampshire Ave., Bldg. 51, Silver                    confidential information that you or a                in the body of your comments and you
                                                    Spring, MD 20993, 301–796–9148.                         third party may not wish to be posted,                must identify this information as
                                                    SUPPLEMENTARY INFORMATION: The Food                     such as medical information, your or                  ‘‘confidential.’’ Any information marked
                                                    and Drug Administration (FDA) is                        anyone else’s Social Security number, or              as ‘‘confidential’’ will not be disclosed
                                                    affirming the signature date for a notice               confidential business information, such               except in accordance with 21 CFR 10.20
                                                    that appeared in the Federal Register on                as a manufacturing process. Please note               and other applicable disclosure law. For
                                                    August 21, 2017 (82 FR 39587). The                      that if you include your name, contact                more information about FDA’s posting
                                                    document announced FDA’s                                information, or other information that                of comments to public dockets, see 80
                                                    determination for the regulatory review                 identifies you in the body of your                    FR 56469, September 18, 2015, or access
                                                    period for RECUVYRA. The document                       comments, that information will be                    the information at: https://www.gpo.gov/
                                                    published with an incorrect date for the                posted on https://www.regulations.gov.                fdsys/pkg/FR-2015-09-18/pdf/2015-
                                                    signature. We affirm that the document                    • If you want to submit a comment                   23389.pdf.
                                                    was signed on August 15, 2017.                          with confidential information that you                   Docket: For access to the docket to
                                                      Dated: August 21, 2017.                               do not wish to be made available to the               read background documents or the
                                                    Leslie Kux,                                             public, submit the comment as a                       electronic and written/paper comments
                                                    Associate Commissioner for Policy.                      written/paper submission and in the                   received, go to https://
                                                    [FR Doc. 2017–17961 Filed 8–21–17; 4:15 pm]
                                                                                                            manner detailed (see ‘‘Written/Paper                  www.regulations.gov and insert the
                                                                                                            Submissions’’ and ‘‘Instructions’’).                  docket number, found in brackets in the
                                                    BILLING CODE 4164–01–P
                                                                                                            Written/Paper Submissions                             heading of this document, into the
                                                                                                                                                                  ‘‘Search’’ box and follow the prompts
                                                                                                               Submit written/paper submissions as
                                                    DEPARTMENT OF HEALTH AND                                                                                      and/or go to the Dockets Management
                                                                                                            follows:
                                                    HUMAN SERVICES                                                                                                Staff, 5630 Fishers Lane, Rm. 1061,
                                                                                                               • Mail/Hand delivery/Courier (for
                                                                                                                                                                  Rockville, MD 20852.
                                                    Food and Drug Administration                            written/paper submissions): Dockets
                                                                                                                                                                     Submit written requests for single
                                                                                                            Management Staff (HFA–305), Food and
                                                    [Docket No. FDA–2016–D–1248]                                                                                  copies of the guidance to the Policy and
                                                                                                            Drug Administration, 5630 Fishers
                                                                                                                                                                  Regulations Staff (HFV–6), Center for
                                                                                                            Lane, Rm. 1061, Rockville, MD 20852.
                                                    Oncology Drugs for Companion                                                                                  Veterinary Medicine, Food and Drug
                                                                                                               • For written/paper comments
                                                    Animals; Guidance for Industry;                                                                               Administration, 7519 Standish Pl.,
                                                                                                            submitted to the Dockets Management
                                                    Availability                                                                                                  Rockville, MD 20855. Send one self-
                                                                                                            Staff, FDA will post your comment, as
                                                                                                                                                                  addressed adhesive label to assist that
                                                    AGENCY:    Food and Drug Administration,                well as any attachments, except for
                                                                                                                                                                  office in processing your requests. See
                                                    HHS.                                                    information submitted, marked and
                                                                                                                                                                  the SUPPLEMENTARY INFORMATION section
                                                    ACTION:   Notice of availability.                       identified, as confidential, if submitted
                                                                                                                                                                  for electronic access to the guidance
                                                                                                            as detailed in ‘‘Instructions.’’
                                                    SUMMARY:   The Food and Drug                               Instructions: All submissions received             document.
                                                    Administration (FDA or Agency) is                       must include the Docket No. FDA–                      FOR FURTHER INFORMATION CONTACT:
                                                    announcing the availability of a                        2016–D–1248 for ‘‘Oncology Drugs for                  Christopher Loss, Center for Veterinary
                                                    guidance for industry #237 entitled                     Companion Animals.’’ Received                         Medicine (HFV–116), Food and Drug
                                                    ‘‘Oncology Drugs for Companion                          comments will be placed in the docket                 Administration, 7500 Standish Pl., Rm.
                                                    Animals.’’ The guidance provides                        and, except for those submitted as                    N310, Rockville, MD 20855, 240–402–
                                                    recommendations for sponsors of                         ‘‘Confidential Submissions,’’ publicly                0619, christopher.loss@fda.hhs.gov.
                                                    investigational oncology drugs for use in               viewable at https://www.regulations.gov               SUPPLEMENTARY INFORMATION:
                                                    companion animals (e.g., dogs, cats, and
asabaliauskas on DSKBBXCHB2PROD with NOTICES




                                                                                                            or at the Dockets Management Staff
                                                    horses), discusses the contents of a new                office between 9 a.m. and 4 p.m.,                     I. Background
                                                    animal drug application for certain                     Monday through Friday.                                   In the Federal Register of June 10,
                                                    oncology drugs, and provides                               • Confidential Submissions—To                      2016 (81 FR 37605), FDA published the
                                                    recommendations on how to address                       submit a comment with confidential                    notice of availability for a draft guidance
                                                    human user safety concerns.                             information that you do not wish to be                entitled ‘‘Oncology Drugs for
                                                    DATES: The announcement of the                          made publicly available, submit your                  Companion Animals’’ giving interested
                                                    guidance is published in the Federal                    comments only as a written/paper                      persons until August 9, 2016, to
                                                    Register on August 23, 2017.                            submission. You should submit two                     comment on the draft guidance. FDA


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Document Created: 2017-08-22 23:52:15
Document Modified: 2017-08-22 23:52:15
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotification of affirmation.
DatesAugust 23, 2017
ContactJoyce Strong, Office of Policy, 10903 New Hampshire Ave., Bldg. 51, Silver Spring, MD 20993, 301-796-9148.
FR Citation82 FR 40008 

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