83_FR_52672 83 FR 52471 - Determination of Regulatory Review Period for Purposes of Patent Extension; TREMFYA

83 FR 52471 - Determination of Regulatory Review Period for Purposes of Patent Extension; TREMFYA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 201 (October 17, 2018)

Page Range52471-52472
FR Document2018-22571

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TREMFYA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

Federal Register, Volume 83 Issue 201 (Wednesday, October 17, 2018)
[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)]
[Notices]
[Pages 52471-52472]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-22571]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2017-E-6371 and FDA-2017-E-6372]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; TREMFYA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has 
determined the regulatory review period for TREMFYA and is publishing 
this notice of that determination as required by law. FDA has made the 
determination because of the submission of applications to the Director 
of the U.S. Patent and Trademark Office (USPTO), Department of 
Commerce, for the extension of a patent which claims that human 
biological product.

DATES: Anyone with knowledge that any of the dates as published (see 
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either 
electronic or written comments and ask for a redetermination by 
December 17, 2018. Furthermore, any interested person may petition FDA 
for a determination regarding whether the applicant for extension acted 
with due diligence during the regulatory review period by April 15, 
2019. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for 
more information.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before December 17, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 17, 2018. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

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 Nos. 
FDA-2017-E-6371 and FDA-2017-E-6372 for ``Determination of Regulatory 
Review Period for Purposes of Patent Extension; TREMFYA.'' Received 
comments, those filed in a timely manner (see ADDRESSES), 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 Sec.  10.20 (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: Beverly Friedman, Office of Regulatory 
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term 
Restoration Act (Pub. L. 100-670) generally provide that a patent may 
be extended for a period of up to 5 years so long as the patented item 
(human drug product, animal drug product, medical device, food 
additive, or color additive) was subject to regulatory review by FDA 
before the item was marketed. Under these acts, a product's regulatory 
review period forms the basis for determining the amount of extension 
an applicant may receive.

[[Page 52472]]

    A regulatory review period consists of two periods of time: A 
testing phase and an approval phase. For human biological products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the biological product becomes effective and runs 
until the approval phase begins. The approval phase starts with the 
initial submission of an application to market the human biological 
product and continues until FDA grants permission to market the 
biological product. Although only a portion of a regulatory review 
period may count toward the actual amount of extension that the 
Director of USPTO may award (for example, half the testing phase must 
be subtracted as well as any time that may have occurred before the 
patent was issued), FDA's determination of the length of a regulatory 
review period for a human biological product will include all of the 
testing phase and approval phase as specified in 35 U.S.C. 
156(g)(1)(B).
    FDA has approved for marketing the human biologic product TREMFYA 
(guselkumab). TREMFYA is indicated for the treatment of adult patients 
with moderate-to-severe plaque psoriasis who are candidates for 
systemic therapy or phototherapy. Subsequent to this approval, the 
USPTO received patent term restoration applications for TREMFYA (U.S. 
Patent Nos.7,935,344 and 7,993,645) from Janssen Biotech, Inc., and the 
USPTO requested FDA's assistance in determining the patents' 
eligibility for patent term restoration. In a letter dated January 9, 
2018, FDA advised the USPTO that this human biological product had 
undergone a regulatory review period and that the approval of TREMFYA 
represented the first permitted commercial marketing or use of the 
product. Thereafter, the USPTO requested that FDA determine the 
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for 
TREMFYA is 2,968 days. Of this time, 2,728 days occurred during the 
testing phase of the regulatory review period, while 240 days occurred 
during the approval phase. These periods of time were derived from the 
following dates:
    1. The date an exemption under section 505(i) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: May 30, 
2009. The applicant claims April 30, 2009, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was May 30, 2009, 
which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to 
the human biological product under section 351 of the Public Health 
Service Act (42 U.S.C. 262): November 16, 2016. FDA has verified the 
applicant's claim that the biologics license application (BLA) for 
TREMFYA (BLA 761061) was initially submitted on November 16, 2016.
    3. The date the application was approved: July 13, 2017. FDA has 
verified the applicant's claim that BLA 761061 was approved on July 13, 
2017.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the USPTO 
applies several statutory limitations in its calculations of the actual 
period for patent extension. In its applications for patent extension, 
this applicant seeks 1,252 days or 1,203 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are 
incorrect may submit either electronic or written comments and, under 
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as 
specified in Sec.  60.30 (21 CFR 60.30), any interested person may 
petition FDA for a determination regarding whether the applicant for 
extension acted with due diligence during the regulatory review period. 
To meet its burden, the petition must comply with all the requirements 
of Sec.  60.30, including but not limited to: Must be timely (see 
DATES), must be filed in accordance with Sec.  10.20, must contain 
sufficient facts to merit an FDA investigation, and must certify that a 
true and complete copy of the petition has been served upon the patent 
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at 
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are 
required) to the Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: October 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22571 Filed 10-16-18; 8:45 am]
 BILLING CODE 4164-01-P



                                                                         Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Notices                                          52471

                                                 Dated: October 3, 2018.                               Electronic Submissions                                copies total. One copy will include the
                                               Seema Verma,                                              Submit electronic comments in the                   information you claim to be confidential
                                               Administrator, Centers for Medicare &                   following way:                                        with a heading or cover note that states
                                               Medicaid Services.
                                                                                                         • Federal eRulemaking Portal:                       ‘‘THIS DOCUMENT CONTAINS
                                                 Dated: October 11, 2018.                              https://www.regulations.gov. Follow the               CONFIDENTIAL INFORMATION.’’ The
                                               Alex M. Azar II,                                        instructions for submitting comments.                 Agency will review this copy, including
                                               Secretary, Department of Health and Human               Comments submitted electronically,                    the claimed confidential information, in
                                               Services.                                               including attachments, to https://                    its consideration of comments. The
                                               [FR Doc. 2018–22530 Filed 10–12–18; 11:15 am]           www.regulations.gov will be posted to                 second copy, which will have the
                                               BILLING CODE 4120–01–P                                  the docket unchanged. Because your                    claimed confidential information
                                                                                                       comment will be made public, you are                  redacted/blacked out, will be available
                                                                                                       solely responsible for ensuring that your             for public viewing and posted on
                                               DEPARTMENT OF HEALTH AND                                comment does not include any                          https://www.regulations.gov. Submit
                                               HUMAN SERVICES                                          confidential information that you or a                both copies to the Dockets Management
                                                                                                       third party may not wish to be posted,                Staff. If you do not wish your name and
                                               Food and Drug Administration                                                                                  contact information to be made publicly
                                                                                                       such as medical information, your or
                                               [Docket Nos. FDA–2017–E–6371 and FDA–                   anyone else’s Social Security number, or              available, you can provide this
                                               2017–E–6372]                                            confidential business information, such               information on the cover sheet and not
                                                                                                       as a manufacturing process. Please note               in the body of your comments and you
                                               Determination of Regulatory Review                      that if you include your name, contact                must identify this information as
                                               Period for Purposes of Patent                           information, or other information that                ‘‘confidential.’’ Any information marked
                                               Extension; TREMFYA                                      identifies you in the body of your                    as ‘‘confidential’’ will not be disclosed
                                               AGENCY:    Food and Drug Administration,                comments, that information will be                    except in accordance with § 10.20 (21
                                               HHS.                                                    posted on https://www.regulations.gov.                CFR 10.20) and other applicable
                                                                                                         • If you want to submit a comment                   disclosure law. For more information
                                               ACTION:   Notice.                                                                                             about FDA’s posting of comments to
                                                                                                       with confidential information that you
                                               SUMMARY:    The Food and Drug                           do not wish to be made available to the               public dockets, see 80 FR 56469,
                                               Administration (FDA or the Agency) has                  public, submit the comment as a                       September 18, 2015, or access the
                                               determined the regulatory review period                 written/paper submission and in the                   information at: https://www.gpo.gov/
                                               for TREMFYA and is publishing this                      manner detailed (see ‘‘Written/Paper                  fdsys/pkg/FR-2015-09-18/pdf/2015-
                                               notice of that determination as required                Submissions’’ and ‘‘Instructions’’).                  23389.pdf.
                                               by law. FDA has made the                                                                                         Docket: For access to the docket to
                                               determination because of the                            Written/Paper Submissions                             read background documents or the
                                               submission of applications to the                         Submit written/paper submissions as                 electronic and written/paper comments
                                               Director of the U.S. Patent and                         follows:                                              received, go to https://
                                               Trademark Office (USPTO), Department                      • Mail/Hand delivery/Courier (for                   www.regulations.gov and insert the
                                               of Commerce, for the extension of a                     written/paper submissions): Dockets                   docket number, found in brackets in the
                                               patent which claims that human                          Management Staff (HFA–305), Food and                  heading of this document, into the
                                               biological product.                                     Drug Administration, 5630 Fishers                     ‘‘Search’’ box and follow the prompts
                                               DATES: Anyone with knowledge that any                   Lane, Rm. 1061, Rockville, MD 20852.                  and/or go to the Dockets Management
                                               of the dates as published (see the                        • For written/paper comments                        Staff, 5630 Fishers Lane, Rm. 1061,
                                               SUPPLEMENTARY INFORMATION section) are                  submitted to the Dockets Management                   Rockville, MD 20852.
                                               incorrect may submit either electronic                  Staff, FDA will post your comment, as                 FOR FURTHER INFORMATION CONTACT:
                                               or written comments and ask for a                       well as any attachments, except for                   Beverly Friedman, Office of Regulatory
                                               redetermination by December 17, 2018.                   information submitted, marked and                     Policy, Food and Drug Administration,
                                               Furthermore, any interested person may                  identified, as confidential, if submitted             10903 New Hampshire Ave., Bldg. 51,
                                               petition FDA for a determination                        as detailed in ‘‘Instructions.’’
                                               regarding whether the applicant for                                                                           Rm. 6250, Silver Spring, MD 20993,
                                                                                                         Instructions: All submissions received
                                               extension acted with due diligence                                                                            301–796–3600.
                                                                                                       must include the Docket Nos. FDA–
                                               during the regulatory review period by                  2017–E–6371 and FDA–2017–E–6372                       SUPPLEMENTARY INFORMATION:
                                               April 15, 2019. See ‘‘Petitions’’ in the                for ‘‘Determination of Regulatory                     I. Background
                                               SUPPLEMENTARY INFORMATION section for                   Review Period for Purposes of Patent
                                               more information.                                       Extension; TREMFYA.’’ Received                          The Drug Price Competition and
                                               ADDRESSES: You may submit comments                      comments, those filed in a timely                     Patent Term Restoration Act of 1984
                                               as follows. Please note that late,                      manner (see ADDRESSES), will be placed                (Pub. L. 98–417) and the Generic
                                               untimely filed comments will not be                     in the docket and, except for those                   Animal Drug and Patent Term
                                               considered. Electronic comments must                    submitted as ‘‘Confidential                           Restoration Act (Pub. L. 100–670)
                                               be submitted on or before December 17,                  Submissions,’’ publicly viewable at                   generally provide that a patent may be
                                               2018. The https://www.regulations.gov                   https://www.regulations.gov or at the                 extended for a period of up to 5 years
                                               electronic filing system will accept                    Dockets Management Staff between 9                    so long as the patented item (human
                                               comments until 11:59 p.m. Eastern Time                  a.m. and 4 p.m., Monday through                       drug product, animal drug product,
daltland on DSKBBV9HB2PROD with NOTICES




                                               at the end of December 17, 2018.                        Friday.                                               medical device, food additive, or color
                                               Comments received by mail/hand                            • Confidential Submissions—To                       additive) was subject to regulatory
                                               delivery/courier (for written/paper                     submit a comment with confidential                    review by FDA before the item was
                                               submissions) will be considered timely                  information that you do not wish to be                marketed. Under these acts, a product’s
                                               if they are postmarked or the delivery                  made publicly available, submit your                  regulatory review period forms the basis
                                               service acceptance receipt is on or                     comments only as a written/paper                      for determining the amount of extension
                                               before that date.                                       submission. You should submit two                     an applicant may receive.


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                                               52472                     Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Notices

                                                  A regulatory review period consists of               which was 30 days after FDA receipt of                DEPARTMENT OF HEALTH AND
                                               two periods of time: A testing phase and                the IND.                                              HUMAN SERVICES
                                               an approval phase. For human                              2. The date the application was
                                               biological products, the testing phase                                                                        Food and Drug Administration
                                                                                                       initially submitted with respect to the
                                               begins when the exemption to permit                                                                           [Docket No. FDA–2018–N–3516]
                                                                                                       human biological product under section
                                               the clinical investigations of the
                                                                                                       351 of the Public Health Service Act (42
                                               biological product becomes effective                                                                          Agency Information Collection
                                               and runs until the approval phase                       U.S.C. 262): November 16, 2016. FDA
                                                                                                                                                             Activities; Proposed Collection;
                                               begins. The approval phase starts with                  has verified the applicant’s claim that
                                                                                                                                                             Comment Request; Disease
                                               the initial submission of an application                the biologics license application (BLA)
                                                                                                                                                             Awareness and Prescription Drug
                                               to market the human biological product                  for TREMFYA (BLA 761061) was                          Promotion on Television
                                               and continues until FDA grants                          initially submitted on November 16,
                                               permission to market the biological                     2016.                                                 AGENCY:    Food and Drug Administration,
                                               product. Although only a portion of a                     3. The date the application was                     HHS.
                                               regulatory review period may count                      approved: July 13, 2017. FDA has                      ACTION:   Notice.
                                               toward the actual amount of extension                   verified the applicant’s claim that BLA               SUMMARY:    The Food and Drug
                                               that the Director of USPTO may award                    761061 was approved on July 13, 2017.                 Administration (FDA or Agency) is
                                               (for example, half the testing phase must
                                                                                                         This determination of the regulatory                announcing an opportunity for public
                                               be subtracted as well as any time that
                                                                                                       review period establishes the maximum                 comment on the proposed collection of
                                               may have occurred before the patent
                                                                                                       potential length of a patent extension.               certain information by the Agency.
                                               was issued), FDA’s determination of the
                                                                                                       However, the USPTO applies several                    Under the Paperwork Reduction Act of
                                               length of a regulatory review period for
                                                                                                       statutory limitations in its calculations             1995 (the PRA), Federal Agencies are
                                               a human biological product will include
                                                                                                       of the actual period for patent extension.            required to publish notice in the
                                               all of the testing phase and approval
                                                                                                       In its applications for patent extension,             Federal Register concerning each
                                               phase as specified in 35 U.S.C.
                                                                                                       this applicant seeks 1,252 days or 1,203              proposed collection of information and
                                               156(g)(1)(B).
                                                  FDA has approved for marketing the                   days of patent term extension.                        to allow 60 days for public comment in
                                               human biologic product TREMFYA                                                                                response to the notice. This notice
                                               (guselkumab). TREMFYA is indicated                      III. Petitions                                        solicits comments on research entitled,
                                               for the treatment of adult patients with                                                                      ‘‘Disease Awareness and Prescription
                                                                                                          Anyone with knowledge that any of                  Drug Promotion on Television.’’
                                               moderate-to-severe plaque psoriasis                     the dates as published are incorrect may
                                               who are candidates for systemic therapy                                                                       DATES: Submit either electronic or
                                                                                                       submit either electronic or written                   written comments on the collection of
                                               or phototherapy. Subsequent to this                     comments and, under 21 CFR 60.24, ask
                                               approval, the USPTO received patent                                                                           information by December 17, 2018.
                                                                                                       for a redetermination (see DATES).                    ADDRESSES: You may submit comments
                                               term restoration applications for
                                                                                                       Furthermore, as specified in § 60.30 (21              as follows. Please note that late,
                                               TREMFYA (U.S. Patent Nos.7,935,344
                                               and 7,993,645) from Janssen Biotech,                    CFR 60.30), any interested person may                 untimely filed comments will not be
                                               Inc., and the USPTO requested FDA’s                     petition FDA for a determination                      considered. Electronic comments must
                                               assistance in determining the patents’                  regarding whether the applicant for                   be submitted on or before December 17,
                                               eligibility for patent term restoration. In             extension acted with due diligence                    2018. The https://www.regulations.gov
                                               a letter dated January 9, 2018, FDA                     during the regulatory review period. To               electronic filing system will accept
                                               advised the USPTO that this human                       meet its burden, the petition must                    comments until midnight Eastern Time
                                               biological product had undergone a                      comply with all the requirements of                   at the end of December 17, 2018.
                                               regulatory review period and that the                   § 60.30, including but not limited to:                Comments received by mail/hand
                                               approval of TREMFYA represented the                     Must be timely (see DATES), must be                   delivery/courier (for written/paper
                                               first permitted commercial marketing or                 filed in accordance with § 10.20, must                submissions) will be considered timely
                                               use of the product. Thereafter, the                     contain sufficient facts to merit an FDA              if they are postmarked or the delivery
                                               USPTO requested that FDA determine                      investigation, and must certify that a                service acceptance receipt is on or
                                               the product’s regulatory review period.                 true and complete copy of the petition                before that date.
                                               II. Determination of Regulatory Review                  has been served upon the patent                       Electronic Submissions
                                               Period                                                  applicant. (See H. Rept. 857, part 1, 98th
                                                                                                       Cong., 2d sess., pp. 41–42, 1984.)                      Submit electronic comments in the
                                                  FDA has determined that the                          Petitions should be in the format                     following way:
                                               applicable regulatory review period for                 specified in 21 CFR 10.30.                              • Federal eRulemaking Portal:
                                               TREMFYA is 2,968 days. Of this time,                                                                          https://www.regulations.gov. Follow the
                                               2,728 days occurred during the testing                     Submit petitions electronically to                 instructions for submitting comments.
                                               phase of the regulatory review period,                  https://www.regulations.gov at Docket                 Comments submitted electronically,
                                               while 240 days occurred during the                      No. FDA–2013–S–0610. Submit written                   including attachments, to https://
                                               approval phase. These periods of time                   petitions (two copies are required) to the            www.regulations.gov will be posted to
                                               were derived from the following dates:                  Dockets Management Staff (HFA–305),                   the docket unchanged. Because your
                                                  1. The date an exemption under                       Food and Drug Administration, 5630                    comment will be made public, you are
                                               section 505(i) of the Federal Food, Drug,               Fishers Lane, Rm. 1061, Rockville, MD                 solely responsible for ensuring that your
daltland on DSKBBV9HB2PROD with NOTICES




                                               and Cosmetic Act (21 U.S.C. 355(i))                     20852.                                                comment does not include any
                                               became effective: May 30, 2009. The                       Dated: October 11, 2018.                            confidential information that you or a
                                               applicant claims April 30, 2009, as the                                                                       third party may not wish to be posted,
                                                                                                       Leslie Kux,
                                               date the investigational new drug                                                                             such as medical information, your or
                                               application (IND) became effective.                     Associate Commissioner for Policy.                    anyone else’s Social Security number, or
                                               However, FDA records indicate that the                  [FR Doc. 2018–22571 Filed 10–16–18; 8:45 am]          confidential business information, such
                                               IND effective date was May 30, 2009,                    BILLING CODE 4164–01–P                                as a manufacturing process. Please note


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Document Created: 2018-10-17 01:47:03
Document Modified: 2018-10-17 01:47:03
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
ActionNotice.
DatesAnyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by December 17, 2018. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by April 15, 2019. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information.
ContactBeverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
FR Citation83 FR 52471 

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