83_FR_53846 83 FR 53640 - Determination of Regulatory Review Period for Purposes of Patent Extension; LARTRUVO

83 FR 53640 - Determination of Regulatory Review Period for Purposes of Patent Extension; LARTRUVO

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 206 (October 24, 2018)

Page Range53640-53641
FR Document2018-23219

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LARTRUVO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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 206 (Wednesday, October 24, 2018)
[Federal Register Volume 83, Number 206 (Wednesday, October 24, 2018)]
[Notices]
[Pages 53640-53641]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-23219]



[[Page 53640]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-E-5106]


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

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 LARTRUVO and is publishing 
this notice of that determination as required by law. FDA has made the 
determination because of the submission of an application 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 24, 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 22, 
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 24, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 24, 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 No. 
FDA-2017-E-5106 for ''Determination of Regulatory Review Period for 
Purposes of Patent Extension; LARTRUVO.'' 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.
    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

[[Page 53641]]

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 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 LARTRUVO 
(olaratumab). LARTRUVO is a platelet-derived growth factor receptor 
alpha blocking antibody indicated, in combination with doxorubicin, for 
the treatment of adult patients with soft tissue sarcoma with a 
histologic subtype for which an anthracycline-containing regimen is 
appropriate and which is not amenable to curative treatment with 
radiotherapy or surgery. This indication is approved under accelerated 
approval. Continued approval for this indication may be contingent upon 
verification and description of clinical benefit in the confirmatory 
trial. Subsequent to this approval, the USPTO received a patent term 
restoration application for LARTRUVO (U.S. Patent No. 8,128,929) from 
Imclone LLC, and the USPTO requested FDA's assistance in determining 
this patent's eligibility for patent term restoration. In a letter 
dated November 6, 2017, FDA advised the USPTO that this human 
biological product had undergone a regulatory review period and that 
the approval of LARTRUVO 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 
LARTRUVO is 3,766 days. Of this time, 3,527 days occurred during the 
testing phase of the regulatory review period, while 239 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: June 30, 
2006. The applicant claims July 1, 2006, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was June 30, 2006, 
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): February 24, 2016. The applicant claims 
December 10, 2015, as the date the biologics license application (BLA) 
for LARTRUVO (BLA 761038) was initially submitted. However, FDA records 
indicate that BLA 761038 was submitted on February 24, 2016.
    3. The date the application was approved: October 19, 2016. FDA has 
verified the applicant's claim that BLA 761038 was approved on October 
19, 2016.
    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 application for patent extension, 
this applicant seeks 1,003 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 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23219 Filed 10-23-18; 8:45 am]
 BILLING CODE 4164-01-P



                                              53640                     Federal Register / Vol. 83, No. 206 / Wednesday, October 24, 2018 / Notices

                                              DEPARTMENT OF HEALTH AND                                comment does not include any                          Staff. If you do not wish your name and
                                              HUMAN SERVICES                                          confidential information that you or a                contact information to be made publicly
                                                                                                      third party may not wish to be posted,                available, you can provide this
                                              Food and Drug Administration                            such as medical information, your or                  information on the cover sheet and not
                                              [Docket No. FDA–2017–E–5106]                            anyone else’s Social Security number, or              in the body of your comments and you
                                                                                                      confidential business information, such               must identify this information as
                                              Determination of Regulatory Review                      as a manufacturing process. Please note               ‘‘confidential.’’ Any information marked
                                              Period for Purposes of Patent                           that if you include your name, contact                as ‘‘confidential’’ will not be disclosed
                                              Extension; LARTRUVO                                     information, or other information that                except in accordance with § 10.20 (21
                                                                                                      identifies you in the body of your                    CFR 10.20) and other applicable
                                              AGENCY:    Food and Drug Administration,                comments, that information will be                    disclosure law. For more information
                                              HHS.                                                    posted on https://www.regulations.gov.                about FDA’s posting of comments to
                                              ACTION:   Notice.                                         • If you want to submit a comment                   public dockets, see 80 FR 56469,
                                                                                                      with confidential information that you                September 18, 2015, or access the
                                              SUMMARY:    The Food and Drug
                                                                                                      do not wish to be made available to the               information at: https://www.gpo.gov/
                                              Administration (FDA or the Agency) has
                                                                                                      public, submit the comment as a                       fdsys/pkg/FR-2015-09-18/pdf/2015-
                                              determined the regulatory review period
                                                                                                      written/paper submission and in the                   23389.pdf.
                                              for LARTRUVO and is publishing this
                                                                                                      manner detailed (see ‘‘Written/Paper                     Docket: For access to the docket to
                                              notice of that determination as required
                                                                                                      Submissions’’ and ‘‘Instructions’’).                  read background documents or the
                                              by law. FDA has made the
                                              determination because of the                            Written/Paper Submissions                             electronic and written/paper comments
                                              submission of an application to the                                                                           received, go to https://
                                                                                                         Submit written/paper submissions as                www.regulations.gov and insert the
                                              Director of the U.S. Patent and                         follows:                                              docket number, found in brackets in the
                                              Trademark Office (USPTO), Department                       • Mail/Hand delivery/Courier (for
                                              of Commerce, for the extension of a                                                                           heading of this document, into the
                                                                                                      written/paper submissions): Dockets
                                              patent which claims that human                                                                                ‘‘Search’’ box and follow the prompts
                                                                                                      Management Staff (HFA–305), Food and
                                              biological product.                                                                                           and/or go to the Dockets Management
                                                                                                      Drug Administration, 5630 Fishers
                                              DATES: Anyone with knowledge that any
                                                                                                                                                            Staff, 5630 Fishers Lane, Rm. 1061,
                                                                                                      Lane, Rm. 1061, Rockville, MD 20852.
                                              of the dates as published (see the                         • For written/paper comments                       Rockville, MD 20852.
                                              SUPPLEMENTARY INFORMATION section) are                  submitted to the Dockets Management                   FOR FURTHER INFORMATION CONTACT:
                                              incorrect may submit either electronic                  Staff, FDA will post your comment, as                 Beverly Friedman, Office of Regulatory
                                              or written comments and ask for a                       well as any attachments, except for                   Policy, Food and Drug Administration,
                                              redetermination by December 24, 2018.                   information submitted, marked and                     10903 New Hampshire Ave., Bldg. 51,
                                              Furthermore, any interested person may                  identified, as confidential, if submitted             Rm. 6250, Silver Spring, MD 20993,
                                              petition FDA for a determination                        as detailed in ‘‘Instructions.’’                      301–796–3600.
                                              regarding whether the applicant for                        Instructions: All submissions received             SUPPLEMENTARY INFORMATION:
                                              extension acted with due diligence                      must include the Docket No. FDA–
                                                                                                      2017–E–5106 for ’’Determination of                    I. Background
                                              during the regulatory review period by
                                              April 22, 2019. See ‘‘Petitions’’ in the                Regulatory Review Period for Purposes                   The Drug Price Competition and
                                              SUPPLEMENTARY INFORMATION section for                   of Patent Extension; LARTRUVO.’’                      Patent Term Restoration Act of 1984
                                              more information.                                       Received comments, those filed in a                   (Pub. L. 98–417) and the Generic
                                              ADDRESSES: You may submit comments                      timely manner (see ADDRESSES), will be                Animal Drug and Patent Term
                                              as follows. Please note that late,                      placed in the docket and, except for                  Restoration Act (Pub. L. 100–670)
                                              untimely filed comments will not be                     those submitted as ‘‘Confidential                     generally provide that a patent may be
                                              considered. Electronic comments must                    Submissions,’’ publicly viewable at                   extended for a period of up to 5 years
                                              be submitted on or before December 24,                  https://www.regulations.gov or at the                 so long as the patented item (human
                                              2018. The https://www.regulations.gov                   Dockets Management Staff between 9                    drug product, animal drug product,
                                              electronic filing system will accept                    a.m. and 4 p.m., Monday through                       medical device, food additive, or color
                                              comments until 11:59 p.m. Eastern Time                  Friday.                                               additive) was subject to regulatory
                                              at the end of December 24, 2018.                           • Confidential Submissions—To                      review by FDA before the item was
                                              Comments received by mail/hand                          submit a comment with confidential                    marketed. Under these acts, a product’s
                                              delivery/courier (for written/paper                     information that you do not wish to be                regulatory review period forms the basis
                                              submissions) will be considered timely                  made publicly available, submit your                  for determining the amount of extension
                                              if they are postmarked or the delivery                  comments only as a written/paper                      an applicant may receive.
                                              service acceptance receipt is on or                     submission. You should submit two                       A regulatory review period consists of
                                              before that date.                                       copies total. One copy will include the               two periods of time: a testing phase and
                                                                                                      information you claim to be confidential              an approval phase. For human
                                              Electronic Submissions                                  with a heading or cover note that states              biological products, the testing phase
                                                Submit electronic comments in the                     ‘‘THIS DOCUMENT CONTAINS                              begins when the exemption to permit
                                              following way:                                          CONFIDENTIAL INFORMATION.’’ The                       the clinical investigations of the
                                                • Federal eRulemaking Portal:                         Agency will review this copy, including               biological product becomes effective
                                              https://www.regulations.gov. Follow the                 the claimed confidential information, in              and runs until the approval phase
amozie on DSK3GDR082PROD with NOTICES1




                                              instructions for submitting comments.                   its consideration of comments. The                    begins. The approval phase starts with
                                              Comments submitted electronically,                      second copy, which will have the                      the initial submission of an application
                                              including attachments, to https://                      claimed confidential information                      to market the human biological product
                                              www.regulations.gov will be posted to                   redacted/blacked out, will be available               and continues until FDA grants
                                              the docket unchanged. Because your                      for public viewing and posted on                      permission to market the biological
                                              comment will be made public, you are                    https://www.regulations.gov. Submit                   product. Although only a portion of a
                                              solely responsible for ensuring that your               both copies to the Dockets Management                 regulatory review period may count


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                                                                        Federal Register / Vol. 83, No. 206 / Wednesday, October 24, 2018 / Notices                                         53641

                                              toward the actual amount of extension                   U.S.C. 262): February 24, 2016. The                   DEPARTMENT OF HEALTH AND
                                              that the Director of USPTO may award                    applicant claims December 10, 2015, as                HUMAN SERVICES
                                              (for example, half the testing phase must               the date the biologics license
                                              be subtracted as well as any time that                  application (BLA) for LARTRUVO (BLA                   Health Resources and Service
                                              may have occurred before the patent                     761038) was initially submitted.                      Administration
                                              was issued), FDA’s determination of the                 However, FDA records indicate that
                                              length of a regulatory review period for                                                                      Meeting of the Advisory Committee on
                                                                                                      BLA 761038 was submitted on February
                                              a human biological product will include                                                                       Interdisciplinary, Community-Based
                                                                                                      24, 2016.                                             Linkages
                                              all the testing phase and approval phase
                                              as specified in 35 U.S.C. 156(g)(1)(B).                   3. The date the application was
                                                                                                      approved: October 19, 2016. FDA has                   AGENCY: Health Resources and Service
                                                 FDA has approved for marketing the
                                                                                                      verified the applicant’s claim that BLA               Administration (HRSA), Department of
                                              human biologic product LARTRUVO
                                                                                                      761038 was approved on October 19,                    Health and Human Services (HHS).
                                              (olaratumab). LARTRUVO is a platelet-
                                              derived growth factor receptor alpha                    2016.                                                 ACTION: Notice.
                                              blocking antibody indicated, in                           This determination of the regulatory                SUMMARY:   The Advisory Committee on
                                              combination with doxorubicin, for the                   review period establishes the maximum                 Interdisciplinary, Community-Based
                                              treatment of adult patients with soft                   potential length of a patent extension.               Linkages (ACICBL) has scheduled a
                                              tissue sarcoma with a histologic subtype                However, the USPTO applies several                    public meeting. Information about the
                                              for which an anthracycline-containing                                                                         ACICBL is located on the ACICBL
                                                                                                      statutory limitations in its calculations
                                              regimen is appropriate and which is not
                                                                                                      of the actual period for patent extension.            website at https://www.hrsa.gov/
                                              amenable to curative treatment with
                                                                                                      In its application for patent extension,              advisory-committees/interdisciplinary-
                                              radiotherapy or surgery. This indication
                                                                                                      this applicant seeks 1,003 days of patent             community-linkages/index.html. This
                                              is approved under accelerated approval.
                                                                                                      term extension.                                       notice is being published less than 15
                                              Continued approval for this indication
                                                                                                                                                            days prior to the meeting date due to
                                              may be contingent upon verification and                 III. Petitions                                        unexpected administrative delays.
                                              description of clinical benefit in the
                                              confirmatory trial. Subsequent to this                     Anyone with knowledge that any of                  DATES: October 30, 2018 from 11:00
                                              approval, the USPTO received a patent                   the dates as published are incorrect may              a.m.–5:00 p.m. ET.
                                              term restoration application for                        submit either electronic or written                   ADDRESSES: This meeting will be held
                                              LARTRUVO (U.S. Patent No. 8,128,929)                    comments and, under 21 CFR 60.24, ask                 through teleconference and webinar.
                                              from Imclone LLC, and the USPTO                         for a redetermination (see DATES).                    The conference call-in number is 1–
                                              requested FDA’s assistance in                           Furthermore, as specified in § 60.30 (21              888–455–0640; passcode: HRSA
                                              determining this patent’s eligibility for               CFR 60.30), any interested person may                 COUNCIL. The webinar link is https://
                                              patent term restoration. In a letter dated              petition FDA for a determination                      hrsa.connectsolutions.com/acicbl.
                                              November 6, 2017, FDA advised the                       regarding whether the applicant for                   FOR FURTHER INFORMATION CONTACT: Joan
                                              USPTO that this human biological                                                                              Weiss, Ph.D., RN, CRNP, FAAN, Senior
                                                                                                      extension acted with due diligence
                                              product had undergone a regulatory                                                                            Advisor and Designated Federal Official
                                                                                                      during the regulatory review period. To
                                              review period and that the approval of                                                                        (DFO), Division of Medicine and
                                              LARTRUVO represented the first                          meet its burden, the petition must
                                                                                                      comply with all the requirements of                   Dentistry, HRSA, 5600 Fishers Lane,
                                              permitted commercial marketing or use                                                                         Room 15N39, Rockville, Maryland
                                              of the product. Thereafter, the USPTO                   § 60.30, including, but not limited to:
                                                                                                                                                            20857; 301–443–0430; or jweiss@
                                              requested that FDA determine the                        Must be timely (see DATES), must be
                                                                                                                                                            hrsa.gov.
                                              product’s regulatory review period.                     filed in accordance with § 10.20, must
                                                                                                      contain sufficient facts to merit an FDA              SUPPLEMENTARY INFORMATION:      ACICBL
                                              II. Determination of Regulatory Review                  investigation, and must certify that a                provides advice and recommendations
                                              Period                                                  true and complete copy of the petition                to the Secretary of HHS (Secretary) and
                                                 FDA has determined that the                          has been served upon the patent                       submits an annual report to the
                                              applicable regulatory review period for                 applicant. (See H. Rept. 857, part 1, 98th            Secretary and Congress on a broad range
                                              LARTRUVO is 3,766 days. Of this time,                   Cong., 2d sess., pp. 41–42, 1984.)                    of issues relating to grant programs
                                              3,527 days occurred during the testing                  Petitions should be in the format                     authorized by Sections 750–760, Title
                                              phase of the regulatory review period,                  specified in 21 CFR 10.30.                            VII, Part D of the Public Health Service
                                              while 239 days occurred during the                                                                            Act (PHS Act).
                                              approval phase. These periods of time                      Submit petitions electronically to                   During the October 30 meeting,
                                              were derived from the following dates:                  https://www.regulations.gov at Docket                 ACICBL members will discuss possible
                                                 1. The date an exemption under                       No. FDA–2013–S–0610. Submit written                   topics to work on for fiscal year 2019.
                                              section 505(i) of the Federal Food, Drug,               petitions (two copies are required) to the            Under Section 757 of the PHS Act,
                                              and Cosmetic Act (21 U.S.C. 355(i))                     Dockets Management Staff (HFA–305),                   ACICBL submits annual reports to the
                                              became effective: June 30, 2006. The                    Food and Drug Administration, 5630                    Secretary, the Committee on Health,
                                              applicant claims July 1, 2006, as the                   Fishers Lane, Rm. 1061, Rockville, MD                 Education, Labor, and Pensions of the
                                              date the investigational new drug                       20852.                                                Senate, and the Committee on Energy
                                              application (IND) became effective.                       Dated: October 19, 2018.
                                                                                                                                                            and Commerce of the House of
                                              However, FDA records indicate that the                                                                        Representatives. Not later than 14 days
amozie on DSK3GDR082PROD with NOTICES1




                                                                                                      Leslie Kux,
                                              IND effective date was June 30, 2006,                                                                         prior to the convening of the meeting,
                                              which was 30 days after FDA receipt of                  Associate Commissioner for Policy.                    ACICBL shall prepare and make
                                              the IND.                                                [FR Doc. 2018–23219 Filed 10–23–18; 8:45 am]          available an agenda of the matters to be
                                                 2. The date the application was                      BILLING CODE 4164–01–P                                considered by ACICBL at the meeting.
                                              initially submitted with respect to the                                                                       The agenda will be posted on the
                                              human biological product under section                                                                        ACICBL website at https://
                                              351 of the Public Health Service Act (42                                                                      www.hrsa.gov/advisory-committees/


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Document Created: 2018-10-24 00:24:32
Document Modified: 2018-10-24 00:24:32
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 24, 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 22, 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 53640 

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