82 FR 41274 - Determination of Regulatory Review Period for Purposes of Patent Extension; KENGREAL

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 167 (August 30, 2017)

Page Range		41274-41276
FR Document		2017-18380

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

Federal Register, Volume 82 Issue 167 (Wednesday, August 30, 2017)

[Federal Register Volume 82, Number 167 (Wednesday, August 30, 2017)]
[Notices]
[Pages 41274-41276]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-18380]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-1283; FDA-2016-E-1291]

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

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 KENGREAL 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 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 October
30, 2017. 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 February 26, 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 October 30, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of October 30, 2017. 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:

[[Page 41275]]

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-2016-E-1283 and FDA-2016-E-1291 for ''Determination of Regulatory
Review Period for Purposes of Patent Extension; KENGREAL.'' 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 Office 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 Office. If you do
not wish your name and contact information to be made publicly
available, you can provide this information on the cover sheet and not
in the body of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.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 Office, 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 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 KENGREAL
(cangrelor tetrasodium). KENGREAL is indicated as an adjunct to
percutaneous coronary intervention for reducing the risk of
periprocedural myocardial infarction, repeat coronary
revascularization, and stent thrombosis in patients who have not been
treated with a P2Y12 platelet inhibitor and are not being
given a glycoprotein IIb/IIIa inhibitor. Subsequent to this approval,
the USPTO received patent term restoration applications for KENGREAL
(U.S. Patent Nos. 6,114,313 and 6,130,208) from AstraZeneca UK Limited,
and the USPTO requested FDA's assistance in determining the patents'
eligibility for patent term restoration. In a letter dated July 12,
2016, FDA advised the USPTO that this human drug product had undergone
a regulatory review period and that the approval of KENGREAL
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
KENGREAL is 6,122 days. Of this time, 5,338 days occurred during the
testing phase of the regulatory review period, while 784 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: September 19, 1998. The applicant claims August 20, 1998, as
the date the investigational new drug application (IND) became
effective. However, FDA records indicate that the IND effective date
was September 19, 1998, which

[[Page 41276]]

was 30 days after FDA receipt of the IND.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: April 30,
2013. FDA has verified the applicant's claim that the new drug
application (NDA) for KENGREAL (NDA 204958) was initially submitted on
April 30, 2013.
3. The date the application was approved: June 22, 2015. FDA has
verified the applicant's claim that NDA 204958 was approved on June 22,
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 5 years 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 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 21 CFR 60.30,
including but not limited to: Must be timely (see DATES), must be filed
in accordance with 21 CFR 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: August 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18380 Filed 8-29-17; 8:45 am]
BILLING CODE 4164-01-P

41274 Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices

mg, and 1.25 mg, were not withdrawn on March 24, 1999. CENESTIN is Dated: August 24, 2017.
from sale for reasons of safety or indicated for treatment of moderate to Anna K. Abram,
effectiveness. This determination will severe vasomotor symptoms due to Deputy Commissioner for Policy, Planning,
allow FDA to approve abbreviated new menopause and treatment of moderate Legislation, and Analysis.
drug applications (ANDAs) for these to severe symptoms of vulvar and [FR Doc. 2017–18376 Filed 8–29–17; 8:45 am]
products, if all other legal and vaginal atrophy due to menopause. BILLING CODE 4164–01–P
regulatory requirements are met. In 2016, Teva notified FDA that
FOR FURTHER INFORMATION CONTACT: CENESTIN (estrogens, conjugated
Bronwen Blass, Center for Drug synthetic A) Tablets, 0.3 mg, 0.45 mg, DEPARTMENT OF HEALTH AND
Evaluation and Research, Food and 0.625 mg, 0.9 mg, and 1.25 mg, were HUMAN SERVICES
Drug Administration, 10903 New being discontinued, and FDA moved the
Hampshire Ave. Bldg. 51, Rm. 6228, drug product to the ‘‘Discontinued Drug Food and Drug Administration
Silver Spring, MD 20993–0002, 301– Product List’’ section of the Orange [Docket Nos. FDA–2016–E–1283; FDA–
796–5092. Book. 2016–E–1291]
Foley & Lardner submitted a citizen
SUPPLEMENTARY INFORMATION: In 1984,
petition dated March 8, 2017 (Docket Determination of Regulatory Review
Congress enacted the Drug Price No. FDA–2017–P–1461), under 21 CFR Period for Purposes of Patent
Competition and Patent Term 10.30, requesting that the Agency Extension; KENGREAL
Restoration Act of 1984 (Pub. L. 98–417) determine whether CENESTIN
(the 1984 amendments), which (estrogens, conjugated synthetic A) AGENCY: Food and Drug Administration,
authorized the approval of duplicate Tablets, 0.3 mg, 0.45 mg, 0.625 mg, 0.9 HHS.
versions of drug products under an mg, and 1.25 mg, were withdrawn from ACTION: Notice.
ANDA procedure. ANDA applicants sale for reasons of safety or
must, with certain exceptions, show that SUMMARY: The Food and Drug
effectiveness. Administration (FDA or the Agency) has
the drug for which they are seeking After considering the citizen and
approval contains the same active determined the regulatory review period
reviewing Agency records and based on
ingredient in the same strength and for KENGREAL and is publishing this
the information we have at this time,
dosage form as the ‘‘listed drug,’’ which notice of that determination as required
FDA has determined under § 314.161
is a version of the drug that was by law. FDA has made the
that CENESTIN (estrogens, conjugated
previously approved. ANDA applicants determination because of the
synthetic A) Tablets, 0.3 mg, 0.45 mg,
do not have to repeat the extensive submission of applications to the
0.625 mg, 0.9 mg, and 1.25 mg, were not
clinical testing otherwise necessary to Director of the U.S. Patent and
withdrawn for reasons of safety or
gain approval of a new drug application Trademark Office (USPTO), Department
effectiveness. The petitioner has
(NDA). of Commerce, for the extension of a
identified no data or other information
The 1984 amendments include what patent which claims that human drug
suggesting that these products were
is now section 505(j)(7) of the Federal product.
withdrawn for reasons of safety or
Food, Drug, and Cosmetic Act (21 U.S.C. effectiveness. We have carefully DATES: Anyone with knowledge that any
355(j)(7)), which requires FDA to reviewed our files for records of the dates as published (in the
publish a list of all approved drugs. concerning the withdrawal of these SUPPLEMENTARY INFORMATION section) are
FDA publishes this list as part of the products from sale. We have also incorrect may submit either electronic
‘‘Approved Drug Products With independently evaluated relevant or written comments and ask for a
Therapeutic Equivalence Evaluations,’’ literature and data for possible redetermination by October 30, 2017.
which is known generally as the postmarketing adverse events. We have Furthermore, any interested person may
‘‘Orange Book.’’ Under FDA regulations, found no information that would petition FDA for a determination
drugs are removed from the list if the indicate that these drug products were regarding whether the applicant for
Agency withdraws or suspends withdrawn from sale for reasons of extension acted with due diligence
approval of the drug’s NDA or ANDA safety or effectiveness. during the regulatory review period by
for reasons of safety or effectiveness or Accordingly, the Agency will February 26, 2018. See ‘‘Petitions’’ in
if FDA determines that the listed drug continue to list CENESTIN (estrogens, the SUPPLEMENTARY INFORMATION section
was withdrawn from sale for reasons of conjugated synthetic A) Tablets, 0.3 mg, for more information.
safety or effectiveness (21 CFR 314.162). 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg, ADDRESSES: You may submit comments
A person may petition the Agency to in the ‘‘Discontinued Drug Product List’’ as follows. Please note that late,
determine, or the Agency may section of the Orange Book. The untimely filed comments will not be
determine on its own initiative, whether ‘‘Discontinued Drug Product List’’ considered. Electronic comments must
a listed drug was withdrawn from sale delineates, among other items, drug be submitted on or before October 30,
for reasons of safety or effectiveness. products that have been discontinued 2017. The https://www.regulations.gov
This determination may be made at any from marketing for reasons other than electronic filing system will accept
time after the drug has been withdrawn safety or effectiveness. ANDAs that refer comments until midnight Eastern Time
from sale, but must be made prior to to CENESTIN (estrogens, conjugated at the end of October 30, 2017.
approving an ANDA that refers to the synthetic A) Tablets, 0.3 mg, 0.45 mg, Comments received by mail/hand
listed drug (§ 314.161 (21 CFR 314.161)). 0.625 mg, 0.9 mg, and 1.25 mg, may be delivery/courier (for written/paper
FDA may not approve an ANDA that approved by the Agency as long as they submissions) will be considered timely
mstockstill on DSK30JT082PROD with NOTICES

does not refer to a listed drug. meet all other legal and regulatory if they are postmarked or the delivery
CENESTIN (estrogens, conjugated requirements for the approval of service acceptance receipt is on or
synthetic A) Tablets, 0.3 mg, 0.45 mg, ANDAs. If FDA determines that labeling before that date.
0.625 mg, 0.9 mg, and 1.25 mg, is the for this drug product should be revised
subject of NDA 020992, held by Teva to meet current standards, the Agency Electronic Submissions
Branded Pharmaceutical Products R&D, will advise ANDA applicants to submit Submit electronic comments in the
Inc. (Teva), and was initially approved such labeling. following way:

VerDate Sep<11>2014 17:40 Aug 29, 2017 Jkt 241001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\30AUN1.SGM 30AUN1

41276 Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices

was 30 days after FDA receipt of the DEPARTMENT OF HEALTH AND HHS, the Director of CDC, and the
IND. HUMAN SERVICES Administrator of HRSA regarding
2. The date the application was objectives, strategies, policies, and
Health Resources and Services priorities for HIV, viral hepatitis, and
initially submitted with respect to the
Administration other STDs; prevention and treatment
human drug product under section
505(b) of the FD&C Act: April 30, 2013. efforts including surveillance of HIV
CDC/HRSA Advisory Committee on
FDA has verified the applicant’s claim infection, AIDS, viral hepatitis and
HIV, Viral Hepatitis and STD Prevention
that the new drug application (NDA) for other STDs, and related behaviors;
and Treatment
KENGREAL (NDA 204958) was initially epidemiologic, behavioral, health
AGENCY: Health Resources and Service services, and laboratory research on
submitted on April 30, 2013.
Administration (HRSA), Department of HIV/AIDS, viral hepatitis, and other
3. The date the application was Health and Human Services (HHS). STDs; identification of policy issues
approved: June 22, 2015. FDA has ACTION: Notice of meeting. related to HIV/viral hepatitis/STD
verified the applicant’s claim that NDA professional education, patient
204958 was approved on June 22, 2015. SUMMARY: In accordance with the healthcare delivery, and prevention
Federal Advisory Committee Act, notice services; HHS policies about prevention
This determination of the regulatory is hereby given that a meeting is
review period establishes the maximum of HIV/AIDS, viral hepatitis and other
scheduled for the Centers for Disease
potential length of a patent extension. STDs; treatment, healthcare delivery,
Control and Prevention (CDC)/HRSA
However, the USPTO applies several and research and training; strategic
Advisory Committee on HIV, Viral
statutory limitations in its calculations Hepatitis and STD Prevention and issues influencing the ability of CDC
of the actual period for patent extension. Treatment. This meeting will be open to and HRSA to fulfill their missions of
In its application for patent extension, the public. Information about the CDC/ providing prevention and treatment
this applicant seeks 5 years of patent HRSA Advisory Committee on HIV, services; programmatic efforts to
term extension. Viral Hepatitis and STD Prevention and prevent and treat HIV, viral hepatitis,
Treatment and the agenda for this and other STDs; and support to CDC
III. Petitions and HRSA in their development of
meeting can be obtained by contacting
CDR Holly Berilla at (301) 443–9965 or responses to emerging health needs
Anyone with knowledge that any of
hberilla@hrsa.gov. related to HIV, viral hepatitis, and other
the dates as published are incorrect may
DATES: October 25, 2017, 9:00 a.m. to STDs.
submit either electronic or written
comments and, under 21 CFR 60.24, ask 5:30 p.m. (Eastern) and October 26, During the October 25 to 26, 2017,
for a redetermination (see DATES). 2017, 9:00 a.m. to 4:15 p.m. (Eastern). meeting, the CDC/HRSA Advisory
Furthermore, as specified in 21 CFR ADDRESSES: This meeting will be held in Committee on HIV, Viral Hepatitis and
60.30, any interested person may person and offer virtual access through STD Prevention and Treatment will
petition FDA for a determination teleconference and Adobe Connect. The discuss strategies to link, retain, and re-
regarding whether the applicant for address for the meeting is 5600 Fishers engage people living with HIV into the
extension acted with due diligence Lane, Pavilion, Rockville, Maryland Ryan White HIV/AIDS Program system
during the regulatory review period. To 20857. The conference call-in number is of care; HAB’s benchmarking and risk
meet its burden, the petition must (888) 469–0566 and passcode is adjustment initiatives; HRSA and CDC
6012320. The webinar link is https:// initiatives regarding congenital syphilis;
comply with all the requirements of 21
hrsa.connectsolutions.com/october_ and committee workgroup reports.
CFR 60.30, including but not limited to:
chac_meeting/. Agenda items are subject to change as
Must be timely (see DATES), must be
FOR FURTHER INFORMATION CONTACT: priorities dictate.
filed in accordance with 21 CFR 10.20,
Those requesting information regarding Members of the public will have the
must contain sufficient facts to merit an
the CDC/HRSA Advisory Committee on opportunity to provide comments. Oral
FDA investigation, and must certify that
HIV, Viral Hepatitis and STD Prevention comments will be honored in the order
a true and complete copy of the petition and Treatment should contact CDR
has been served upon the patent they are requested and may be limited
Holly Berilla, Senior Public Health as time allows. Requests to make oral
applicant. (See H. Rept. 857, part 1, 98th Analyst, Division of Policy and Data
Cong., 2d sess., pp. 41–42, 1984.) comments or provide written comments
(DPD), HIV/AIDS Bureau (HAB), HRSA, to the CDC/HRSA Advisory Committee
Petitions should be in the format in one of three ways: (1) Mail a request
specified in 21 CFR 10.30. on HIV, Viral Hepatitis and STD
to CDR Holly Berilla, Senior Public Prevention and Treatment should be
Submit petitions electronically to Health Analyst, HRSA/HAB/DPD, 5600 sent to CDR Holly Berilla, using the
https://www.regulations.gov at Docket Fishers Lane, 9N164C, Rockville,
contact information listed above, by
No. FDA–2013–S–0610. Submit written Maryland 20857; (2) call (301) 443–
October 11, 2017.
petitions (two copies are required) to the 9965; or (3) send an email to hberilla@
hrsa.gov. The building at 5600 Fishers Lane,
Dockets Management Staff (HFA–305),
SUPPLEMENTARY INFORMATION: The CDC/ Rockville, MD 20857, requires a security
Food and Drug Administration, 5630
HRSA Advisory Committee on HIV, screening on entry. To facilitate your
Fishers Lane, Rm. 1061, Rockville, MD
Viral Hepatitis and STD Prevention and access to the building please contact
20852.
Treatment was established under CDR Holly Berilla (contact information
mstockstill on DSK30JT082PROD with NOTICES

Dated: August 24, 2017. Section 222 of the Public Health Service provided above). Individuals who plan
Anna K. Abram, Act, [42 U.S.C. Section 217a], as to attend and need special assistance,
Deputy Commissioner for Policy, Planning, amended. such as sign language interpretation or
Legislation, and Analysis. The purpose of the CDC/HRSA other reasonable accommodations,
[FR Doc. 2017–18380 Filed 8–29–17; 8:45 am] Advisory Committee on HIV, Viral should notify CDR Holly Berilla (contact
BILLING CODE 4164–01–P
Hepatitis and STD Prevention and information provided above) at least 10
Treatment is to advise the Secretary of days prior to the meeting.

VerDate Sep<11>2014 17:40 Aug 29, 2017 Jkt 241001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\30AUN1.SGM 30AUN1

Document Created: 2017-08-30 04:08:45
Document Modified: 2017-08-30 04:08:45

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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 October 30, 2017. 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 February 26, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more 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.
FR Citation		82 FR 41274

82 FR 41274 - Determination of Regulatory Review Period for Purposes of Patent Extension; KENGREAL

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 167 (August 30, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration