83_FR_5808 83 FR 5780 - Determination of Regulatory Review Period for Purposes of Patent Extension; ODOMZO

83 FR 5780 - Determination of Regulatory Review Period for Purposes of Patent Extension; ODOMZO

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 28 (February 9, 2018)

Page Range5780-5781
FR Document2018-02658

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ODOMZO 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 drug product.

Federal Register, Volume 83 Issue 28 (Friday, February 9, 2018)
[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Pages 5780-5781]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-02658]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-1289]


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

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 ODOMZO 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 drug 
product.

DATES: Anyone with knowledge that any of the dates as published (in the 
SUPPLEMENTARY INFORMATION section) are incorrect may submit either 
electronic or written comments and ask for a redetermination by April 
10, 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 August 8, 2018. 
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 April 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of April 10, 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-2016-E-1289 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; ODOMZO.'' 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

[[Page 5781]]

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 drug products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the drug becomes effective and runs until the 
approval phase begins. The approval phase starts with the initial 
submission of an application to market the human drug product and 
continues until FDA grants permission to market the drug 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 
drug 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 drug product ODOMZO 
(sonidegib phosphate). ODOMZO is indicated for the treatment of adult 
patients with locally advanced basal cell carcinoma that has recurred 
following surgery or radiation therapy, or those who are not candidates 
for surgery or radiation therapy. Subsequent to this approval, the 
USPTO received a patent term restoration application for ODOMZO (U.S. 
Patent No. 8,178,563) from Novartis AG, and the USPTO requested FDA's 
assistance in determining this patent's eligibility for patent term 
restoration. In a letter dated July 28, 2016, FDA advised the USPTO 
that this human drug product had undergone a regulatory review period 
and that the approval of ODOMZO 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 
ODOMZO is 2,414 days. Of this time, 2,112 days occurred during the 
testing phase of the regulatory review period, while 302 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 (the FD&C Act) (21 U.S.C. 355(i)) became 
effective: December 15, 2008. FDA has verified the applicant's claim 
that December 15, 2008, is the date the investigational new drug 
application (IND) became effective.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: September 
26, 2014. FDA has verified the applicant's claim that the new drug 
application (NDA) for ODOMZO (NDA 205266) was initially submitted on 
September 26, 2014.
    3. The date the application was approved: July 24, 2015. FDA has 
verified the applicant's claim that NDA 205266 was approved on July 24, 
2015.
    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 169 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 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: February 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02658 Filed 2-8-18; 8:45 am]
 BILLING CODE 4164-01-P



                                                5780                           Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices

                                                contain sufficient facts to merit an FDA                be submitted on or before April 10,                   https://www.regulations.gov or at the
                                                investigation, and must certify that a                  2018. The https://www.regulations.gov                 Dockets Management Staff between 9
                                                true and complete copy of the petition                  electronic filing system will accept                  a.m. and 4 p.m., Monday through
                                                has been served upon the patent                         comments until midnight Eastern Time                  Friday.
                                                applicant. (See H. Rept. 857, part 1, 98th              at the end of April 10, 2018. Comments                   • Confidential Submissions—To
                                                Cong., 2d sess., pp. 41–42, 1984.)                      received by mail/hand delivery/courier                submit a comment with confidential
                                                Petitions should be in the format                       (for written/paper submissions) will be               information that you do not wish to be
                                                specified in 21 CFR 10.30.                              considered timely if they are                         made publicly available, submit your
                                                  Submit petitions electronically to                    postmarked or the delivery service                    comments only as a written/paper
                                                https://www.regulations.gov at Docket                   acceptance receipt is on or before that               submission. You should submit two
                                                No. FDA–2013–S–0610. Submit written                     date.                                                 copies total. One copy will include the
                                                petitions (two copies are required) to the                                                                    information you claim to be confidential
                                                Dockets Management Staff (HFA–305),                     Electronic Submissions
                                                                                                                                                              with a heading or cover note that states
                                                Food and Drug Administration, 5630                        Submit electronic comments in the                   ‘‘THIS DOCUMENT CONTAINS
                                                Fishers Lane, Rm. 1061, Rockville, MD                   following way:                                        CONFIDENTIAL INFORMATION.’’ The
                                                20852.                                                    • Federal eRulemaking Portal:                       Agency will review this copy, including
                                                                                                        https://www.regulations.gov. Follow the               the claimed confidential information, in
                                                  Dated: February 5, 2018.
                                                                                                        instructions for submitting comments.                 its consideration of comments. The
                                                Leslie Kux,
                                                                                                        Comments submitted electronically,                    second copy, which will have the
                                                Associate Commissioner for Policy.                      including attachments, to https://                    claimed confidential information
                                                [FR Doc. 2018–02582 Filed 2–8–18; 8:45 am]              www.regulations.gov will be posted to                 redacted/blacked out, will be available
                                                BILLING CODE 4164–01–P                                  the docket unchanged. Because your                    for public viewing and posted on
                                                                                                        comment will be made public, you are                  https://www.regulations.gov. Submit
                                                                                                        solely responsible for ensuring that your             both copies to the Dockets Management
                                                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–2016–E–1289]                            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; ODOMZO                                       information, or other information that                except in accordance with § 10.20 (21
                                                AGENCY:    Food and Drug Administration,                identifies you in the body of your                    CFR 10.20) and other applicable
                                                HHS.                                                    comments, that information will be                    disclosure law. For more information
                                                ACTION:   Notice.                                       posted on https://www.regulations.gov.                about FDA’s posting of comments to
                                                                                                          • If you want to submit a comment                   public dockets, see 80 FR 56469,
                                                SUMMARY:   The Food and Drug                            with confidential information that you                September 18, 2015, or access the
                                                Administration (FDA or the Agency) has                  do not wish to be made available to the               information at: https://www.gpo.gov/
                                                determined the regulatory review period                 public, submit the comment as a                       fdsys/pkg/FR-2015-09-18/pdf/2015-
                                                for ODOMZO and is publishing this                       written/paper submission and in the                   23389.pdf.
                                                notice of that determination as required                manner detailed (see ‘‘Written/Paper                     Docket: For access to the docket to
                                                by law. FDA has made the                                Submissions’’ and ‘‘Instructions’’).                  read background documents or the
                                                determination because of the                            Written/Paper Submissions                             electronic and written/paper comments
                                                submission of an application to the                                                                           received, go to https://
                                                Director of the U.S. Patent and                           Submit written/paper submissions as
                                                                                                                                                              www.regulations.gov and insert the
                                                Trademark Office (USPTO), Department                    follows:
                                                                                                          • Mail/Hand delivery/Courier (for                   docket number, found in brackets in the
                                                of Commerce, for the extension of a                                                                           heading of this document, into the
                                                patent which claims that human drug                     written/paper submissions): Dockets
                                                                                                        Management Staff (HFA–305), Food and                  ‘‘Search’’ box and follow the prompts
                                                product.                                                                                                      and/or go to the Dockets Management
                                                                                                        Drug Administration, 5630 Fishers
                                                DATES: Anyone with knowledge that any                   Lane, Rm. 1061, Rockville, MD 20852.                  Staff, 5630 Fishers Lane, Rm. 1061,
                                                of the dates as published (in 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 April 10, 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–
                                                during the regulatory review period by                  2016–E–1289 for ‘‘Determination of                    I. Background
sradovich on DSK3GMQ082PROD with NOTICES




                                                August 8, 2018. See ‘‘Petitions’’ in the                Regulatory Review Period for Purposes                   The Drug Price Competition and
                                                SUPPLEMENTARY INFORMATION section for                   of Patent Extension; ODOMZO.’’                        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


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                                                                               Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices                                                 5781

                                                so long as the patented item (human                       1. The date an exemption under                        Dated: February 6, 2018.
                                                drug product, animal drug product,                      section 505(i) of the Federal Food, Drug,             Leslie Kux,
                                                medical device, food additive, or color                 and Cosmetic Act (the FD&C Act) (21                   Associate Commissioner for Policy.
                                                additive) was subject to regulatory                     U.S.C. 355(i)) became effective:                      [FR Doc. 2018–02658 Filed 2–8–18; 8:45 am]
                                                review by FDA before the item was                       December 15, 2008. FDA has verified                   BILLING CODE 4164–01–P
                                                marketed. Under these acts, a product’s                 the applicant’s claim that December 15,
                                                regulatory review period forms the basis                2008, is the date the investigational new
                                                for determining the amount of extension                 drug application (IND) became effective.              DEPARTMENT OF HEALTH AND
                                                an applicant may receive.                                                                                     HUMAN SERVICES
                                                   A regulatory review period consists of                 2. The date the application was
                                                two periods of time: A testing phase and                initially submitted with respect to the               Food and Drug Administration
                                                an approval phase. For human drug                       human drug product under section
                                                                                                                                                              [Docket Nos. FDA–2016–E–1851; FDA–
                                                products, the testing phase begins when                 505(b) of the FD&C Act: September 26,                 2016–E–1878; FDA–2016–E–1879; FDA–
                                                the exemption to permit the clinical                    2014. FDA has verified the applicant’s                2016–E–1880; and FDA–2016–E–1882]
                                                investigations of the drug becomes                      claim that the new drug application
                                                effective and runs until the approval                   (NDA) for ODOMZO (NDA 205266) was                     Determination of Regulatory Review
                                                phase begins. The approval phase starts                 initially submitted on September 26,                  Period for Purposes of Patent
                                                with the initial submission of an                       2014.                                                 Extension; ENTRESTO
                                                application to market the human drug
                                                                                                          3. The date the application was                     AGENCY:    Food and Drug Administration,
                                                product and continues until FDA grants
                                                permission to market the drug product.                  approved: July 24, 2015. FDA has                      HHS.
                                                Although only a portion of a regulatory                 verified the applicant’s claim that NDA               ACTION:   Notice.
                                                review period may count toward the                      205266 was approved on July 24, 2015.
                                                                                                                                                              SUMMARY:   The Food and Drug
                                                actual amount of extension that the                       This determination of the regulatory                Administration (FDA or the Agency) has
                                                Director of USPTO may award (for                        review period establishes the maximum                 determined the regulatory review period
                                                example, half the testing phase must be                 potential length of a patent extension.               for ENTRESTO and is publishing this
                                                subtracted as well as any time that may                 However, the USPTO applies several                    notice of that determination as required
                                                have occurred before the patent was                     statutory limitations in its calculations             by law. FDA has made the
                                                issued), FDA’s determination of the                     of the actual period for patent extension.            determination because of the
                                                length of a regulatory review period for                In its application for patent extension,              submission of applications to the
                                                a human drug product will include all                   this applicant seeks 169 days of patent               Director of the U.S. Patent and
                                                of the testing phase and approval phase                 term extension.                                       Trademark Office (USPTO), Department
                                                as specified in 35 U.S.C. 156(g)(1)(B).                                                                       of Commerce, for the extension of a
                                                   FDA has approved for marketing the                   III. Petitions                                        patent which claims that human drug
                                                human drug product ODOMZO                                                                                     product.
                                                (sonidegib phosphate). ODOMZO is                          Anyone with knowledge that any of
                                                indicated for the treatment of adult                    the dates as published are incorrect may              DATES: Anyone with knowledge that any
                                                patients with locally advanced basal cell               submit either electronic or written                   of the dates as published (in the
                                                carcinoma that has recurred following                   comments and, under 21 CFR 60.24, ask                 SUPPLEMENTARY INFORMATION section) are
                                                surgery or radiation therapy, or those                  for a redetermination (see DATES).                    incorrect may submit either electronic
                                                who are not candidates for surgery or                   Furthermore, as specified in § 60.30 (21              or written comments and ask for a
                                                radiation therapy. Subsequent to this                   CFR 60.30), any interested person may                 redetermination by April 10, 2018.
                                                approval, the USPTO received a patent                   petition FDA for a determination                      Furthermore, any interested person may
                                                term restoration application for                        regarding whether the applicant for                   petition FDA for a determination
                                                ODOMZO (U.S. Patent No. 8,178,563)                      extension acted with due diligence                    regarding whether the applicant for
                                                from Novartis AG, and the USPTO                         during the regulatory review period. To               extension acted with due diligence
                                                requested FDA’s assistance in                                                                                 during the regulatory review period by
                                                                                                        meet its burden, the petition comply
                                                determining this patent’s eligibility for                                                                     August 8, 2018. See ‘‘Petitions’’ in the
                                                                                                        with all the requirements of § 60.30,
                                                patent term restoration. In a letter dated                                                                    SUPPLEMENTARY INFORMATION section for
                                                                                                        including but not limited to: Must be
                                                July 28, 2016, FDA advised the USPTO                                                                          more information.
                                                                                                        timely (see DATES), must be filed in
                                                that this human drug product had                                                                              ADDRESSES: You may submit comments
                                                                                                        accordance with § 10.20, must contain
                                                undergone a regulatory review period                                                                          as follows. Please note that late,
                                                                                                        sufficient facts to merit an FDA
                                                and that the approval of ODOMZO                                                                               untimely filed comments will not be
                                                represented the first permitted                         investigation, and must certify that a                considered. Electronic comments must
                                                commercial marketing or use of the                      true and complete copy of the petition                be submitted on or before April 10,
                                                product. Thereafter, the USPTO                          has been served upon the patent                       2018. The https://www.regulations.gov
                                                requested that FDA determine the                        applicant. (See H. Rept. 857, part 1, 98th            electronic filing system will accept
                                                product’s regulatory review period.                     Cong., 2d sess., pp. 41–42, 1984.)                    comments until midnight Eastern Time
                                                                                                        Petitions should be in the format                     at the end of April 10, 2018. Comments
                                                II. Determination of Regulatory Review                  specified in 21 CFR 10.30.                            received by mail/hand delivery/courier
                                                Period
                                                                                                          Submit petitions electronically to                  (for written/paper submissions) will be
                                                   FDA has determined that the
sradovich on DSK3GMQ082PROD with NOTICES




                                                                                                        https://www.regulations.gov at Docket                 considered timely if they are
                                                applicable regulatory review period for                 No. FDA–2013–S–0610. Submit written                   postmarked or the delivery service
                                                ODOMZO is 2,414 days. Of this time,                                                                           acceptance receipt is on or before that
                                                                                                        petitions (two copies are required) to the
                                                2,112 days occurred during the testing                                                                        date.
                                                                                                        Dockets Management Staff (HFA–305),
                                                phase of the regulatory review period,
                                                                                                        Food and Drug Administration, 5630                    Electronic Submissions
                                                while 302 days occurred during the
                                                approval phase. These periods of time                   Fishers Lane, Rm. 1061, Rockville, MD                   Submit electronic comments in the
                                                were derived from the following dates:                  20852.                                                following way:


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Document Created: 2018-02-09 00:12:00
Document Modified: 2018-02-09 00:12:00
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 (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 10, 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 August 8, 2018. 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 5780 

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