83 FR 4224 - Determination of Regulatory Review Period for Purposes of Patent Extension; SAPIEN 3 TRANSCATHETER HEART VALVE

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 20 (January 30, 2018)

Page Range		4224-4226
FR Document		2018-01655

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SAPIEN 3 TRANSCATHETER HEART VALVE 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 medical device.

Federal Register, Volume 83 Issue 20 (Tuesday, January 30, 2018)

[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Notices]
[Pages 4224-4226]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-01655]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-1279 and FDA-2016-E-1282]

Determination of Regulatory Review Period for Purposes of Patent
Extension; SAPIEN 3 TRANSCATHETER HEART VALVE

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 SAPIEN 3 TRANSCATHETER
HEART VALVE 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 medical device.

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
2, 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 July 30, 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 2, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 2, 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://

[[Page 4225]]

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 Office, 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-1279 and FDA-2016-1282 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; SAPIEN 3 TRANSCATHETER
HEART VALVE.'' 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 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 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 medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (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 medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
FDA has approved for marketing the medical device SAPIEN 3
TRANSCATHETER HEART VALVE. SAPIEN 3 TRANSCATHETER HEART VALVE is
indicated for relief of aortic stenosis in patients with symptomatic
heart disease due to severe native calcific aortic stenosis who are
judged by a heart team, including a cardiac surgeon, to be at high or
greater risk for open surgical therapy (i.e., Society of Thoracic
Surgeons Operative Risk score 8 percent or at a 15 percent risk of
mortality at 30 days). Subsequent to this approval, the USPTO received
a patent term restoration application for SAPIEN 3 TRANSCATHETER HEART
VALVE (U.S. Patent Nos. 7,585,321 and 8,591,575) from Edwards
Lifesciences PVT, Inc., 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 medical
device had undergone a regulatory review period and that the approval
of SAPIEN 3 TRANSCATHETER HEART VALVE 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
SAPIEN 3 TRANSCATHETER HEART VALVE is 1,736 days. Of this time, 1,558
days occurred during the testing phase of the regulatory review period,
while 178 days occurred during the approval phase. These periods of
time were derived from the following dates:
1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving
this device became effective: September 17, 2010. The applicant claims
that the investigational device exemption (IDE) required under section
520(g) of the FD&C Act for human tests to begin became effective on
July 31, 2014. However, FDA records indicate that the

[[Page 4226]]

IDE was determined substantially complete for clinical studies to have
begun on September 17, 2010, which represents the IDE effective date.
2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): December
22, 2014. The applicant claims December 19, 2014, as the date the
premarket approval application (PMA) for SAPIEN 3 TRANSCATHETER HEART
VALVE (PMA P140031) was initially submitted. However, FDA records
indicate that PMA P140031 was submitted on December 22, 2014.
3. The date the application was approved: June 17, 2015. FDA has
verified the applicant's claim that PMA P140031 was approved on June
17, 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 applications for patent extension,
this applicant seeks 250 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: January 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01655 Filed 1-29-18; 8:45 am]
BILLING CODE 4164-01-P

4224 Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Notices

Although only a portion of a regulatory 207981) was initially submitted on DEPARTMENT OF HEALTH AND
review period may count toward the December 19, 2014. HUMAN SERVICES
actual amount of extension that the 3. The date the application was
Director of USPTO may award (for Food and Drug Administration
approved: September 22, 2015. FDA has
example, half the testing phase must be
verified the applicant’s claim that NDA [Docket Nos. FDA–2016–E–1279 and FDA–
subtracted as well as any time that may 2016–E–1282]
207981 was approved on September 22,
have occurred before the patent was
issued), FDA’s determination of the 2015.
Determination of Regulatory Review
length of a regulatory review period for This determination of the regulatory Period for Purposes of Patent
a human drug product will include all review period establishes the maximum Extension; SAPIEN 3
of the testing phase and approval phase potential length of a patent extension. TRANSCATHETER HEART VALVE
as specified in 35 U.S.C. 156(g)(1)(B). However, the USPTO applies several
FDA has approved for marketing the statutory limitations in its calculations AGENCY: Food and Drug Administration,
human drug product LONSURF of the actual period for patent extension. HHS.
(trifluridine and tipiracil In its applications for patent extension, ACTION: Notice.
hydrochloride). LONSURF is indicated this applicant seeks 1,827 days or 1,013
for the treatment of patients with SUMMARY: The Food and Drug
days of patent term extension.
metastatic colorectal cancer who have Administration (FDA or the Agency) has
been previously treated with III. Petitions determined the regulatory review period
fluoropyrimidine-, oxalplatin- and for SAPIEN 3 TRANSCATHETER
irinotecan-based chemotherapy, an anti- Anyone with knowledge that any of HEART VALVE and is publishing this
vascular endothelial growth factor the dates as published are incorrect may notice of that determination as required
biological therapy, and if RAS wild- submit either electronic or written by law. FDA has made the
type, an anti-epidermal growth factor comments and, under 21 CFR 60.24, ask determination because of the
receptor therapy. Subsequent to this for a redetermination (see DATES). submission of applications to the
approval, the USPTO received patent Furthermore, as specified in § 60.30 (21 Director of the U.S. Patent and
term restoration applications for CFR 60.30), any interested person may Trademark Office (USPTO), Department
LONSURF (U.S. Patent Nos. 6,479,500 petition FDA for a determination of Commerce, for the extension of a
and 7,799,783) from Taiho regarding whether the applicant for patent which claims that medical
Pharmaceutical Co., Ltd., and the extension acted with due diligence device.
USPTO requested FDA’s assistance in during the regulatory review period. To DATES: Anyone with knowledge that any
determining the patents’ eligibility for meet its burden, the petition must of the dates as published (in the
patent term restoration. In a letter dated comply with all the requirements of SUPPLEMENTARY INFORMATION section) are
October 14, 2016, FDA advised the § 60.30, including but not limited to: incorrect may submit either electronic
USPTO that this human drug product must be timely (see DATES), must be or written comments and ask for a
had undergone a regulatory review
filed in accordance with § 10.20, must redetermination by April 2, 2018.
period and that the approval of
contain sufficient facts to merit an FDA Furthermore, any interested person may
LONSURF represented the first
investigation, and must certify that a petition FDA for a determination
permitted commercial marketing or use
true and complete copy of the petition regarding whether the applicant for
of the product. Thereafter, the USPTO
has been served upon the patent extension acted with due diligence
requested that FDA determine the
applicant. (See H. Rept. 857, part 1, 98th during the regulatory review period by
product’s regulatory review period.
Cong., 2d sess., pp. 41–42, 1984.) July 30, 2018. See ‘‘Petitions’’ in the
II. Determination of Regulatory Review Petitions should be in the format SUPPLEMENTARY INFORMATION section for
Period specified in 21 CFR 10.30. more information.
FDA has determined that the ADDRESSES: You may submit comments
Submit petitions electronically to
applicable regulatory review period for https://www.regulations.gov at Docket as follows. Please note that late,
LONSURF is 6,083 days. Of this time, untimely filed comments will not be
No. FDA–2013–S–0610. Submit written
5,805 days occurred during the testing considered. Electronic comments must
petitions (two copies are required) to the
phase of the regulatory review period, be submitted on or before April 2, 2018.
Dockets Management Staff (HFA–305), The https://www.regulations.gov
while 278 days occurred during the
Food and Drug Administration, 5630 electronic filing system will accept
approval phase. These periods of time
were derived from the following dates: Fishers Lane, Rm. 1061, Rockville, MD comments until midnight Eastern Time
1. The date an exemption under 20852. at the end of April 2, 2018. Comments
section 505(i) of the Federal Food, Drug, Dated: January 24, 2018. received by mail/hand delivery/courier
and Cosmetic Act (the FD&C Act) (21 Leslie Kux, (for written/paper submissions) will be
U.S.C. 355(i)) became effective: January Associate Commissioner for Policy.
considered timely if they are
28, 1999. FDA has verified the Taiho postmarked or the delivery service
[FR Doc. 2018–01641 Filed 1–29–18; 8:45 am]
Pharmaceutical Co., Ltd. claim that acceptance receipt is on or before that
January 28, 1999, is the date the BILLING CODE 4164–01–P date.
investigational new drug application
Electronic Submissions
(IND) became effective.
daltland on DSKBBV9HB2PROD with NOTICES

2. The date the application was Submit electronic comments in the
initially submitted with respect to the following way:
human drug product under section • Federal eRulemaking Portal:
505(b)/507 of the FD&C Act: December https://www.regulations.gov. Follow the
19, 2014. FDA has verified the instructions for submitting comments.
applicant’s claim that the new drug Comments submitted electronically,
application (NDA) for LONSURF (NDA including attachments, to https://

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4226 Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Notices

IDE was determined substantially Dated: January 24, 2018. (Catalogue of Federal Domestic Assistance
complete for clinical studies to have Leslie Kux, Program Nos. 93.859, Pharmacology,
Physiology, and Biological Chemistry
begun on September 17, 2010, which Associate Commissioner for Policy.
Research; 93.350, B—Cooperative
represents the IDE effective date. [FR Doc. 2018–01655 Filed 1–29–18; 8:45 am] Agreements; 93.859, Biomedical Research
2. The date an application was BILLING CODE 4164–01–P and Research Training, National Institutes of
initially submitted with respect to the Health, HHS)
device under section 515 of the FD&C Dated: January 25, 2018.
Act (21 U.S.C. 360e): December 22, DEPARTMENT OF HEALTH AND David Clary,
HUMAN SERVICES
2014. The applicant claims December Program Analyst, Office of Federal Advisory
19, 2014, as the date the premarket Committee Policy.
National Institutes of Health
approval application (PMA) for SAPIEN [FR Doc. 2018–01822 Filed 1–29–18; 8:45 am]
3 TRANSCATHETER HEART VALVE National Center for Advancing BILLING CODE 4140–01–P
(PMA P140031) was initially submitted. Translational Sciences; Notice of
However, FDA records indicate that Closed Meetings
PMA P140031 was submitted on DEPARTMENT OF HEALTH AND
Pursuant to section 10(d) of the HUMAN SERVICES
December 22, 2014. Federal Advisory Committee Act, as
3. The date the application was amended, notice is hereby given of the National Institutes of Health
approved: June 17, 2015. FDA has National Center for Advancing
verified the applicant’s claim that PMA Translational Sciences Special National Institute on Aging; Notice of
P140031 was approved on June 17, Emphasis Panel. Closed Meetings
2015. The meetings will be closed to the Pursuant to section 10(d) of the
This determination of the regulatory public in accordance with the Federal Advisory Committee Act, as
review period establishes the maximum provisions set forth in sections amended, notice is hereby given of the
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., following meetings.
potential length of a patent extension.
as amended. The grant applications and The meetings will be closed to the
However, the USPTO applies several
the discussions could disclose public in accordance with the
statutory limitations in its calculations
confidential trade secrets or commercial provisions set forth in sections
of the actual period for patent extension. property such as patentable material, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
In its applications for patent extension, and personal information concerning as amended. The grant applications and
this applicant seeks 250 days of patent individuals associated with the grant the discussions could disclose
term extension. applications, the disclosure of which confidential trade secrets or commercial
III. Petitions would constitute a clearly unwarranted property such as patentable material,
invasion of personal privacy. and personal information concerning
Anyone with knowledge that any of Name of Committee: National Center for individuals associated with the grant
the dates as published are incorrect may Advancing Translational Sciences Special applications, the disclosure of which
submit either electronic or written Emphasis Panel; CTSA Collaborative would constitute a clearly unwarranted
comments and, under 21 CFR 60.24, ask Innovation Award Review. invasion of personal privacy.
for a redetermination (see DATES). Date: February 22–23, 2018.
Name of Committee: National Institute on
Time: 8:00 a.m. to 5:00 p.m.
Furthermore, as specified in § 60.30 (21 Aging Special Emphasis Panel; GEMSSTAR.
Agenda: To review and evaluate grant Date: February 26, 2018.
CFR 60.30), any interested person may applications.
petition FDA for a determination Time: 8:00 a.m. to 6:00 p.m.
Place: National Institutes of Health, Agenda: To review and evaluate grant
regarding whether the applicant for Democracy I, Room 1068, 6701 Democracy applications.
extension acted with due diligence Blvd., Bethesda, MD 20817 (Virtual Meeting). Place: Bethesda Marriott Hotel, 5151 Pooks
during the regulatory review period. To Contact Person: M. Lourdes Ponce, Ph.D., Hill Road, Bethesda, MD 20814.
meet its burden, the petition must Scientific Review Officer, Office of Scientific Contact Person: Isis S. Mikhail, MD, MPH,
Review, National Center for Advancing DRPH, National Institute on Aging, Gateway
comply with all the requirements of Translational Sciences (NCATS), National
§ 60.30, including but not limited to: Building, 7201 Wisconsin Avenue, Suite
Institutes of Health, 6701 Democracy Blvd., 2C212, Bethesda, MD 20892, 301–402–7704,
Must be timely (see DATES), must be Democracy I, Room 1073 Bethesda, MD MIKHAILI@MAIL.NIH.GOV.
filed in accordance with § 10.20, must 20892, 301–435–0810, lourdes.ponce@ Name of Committee: National Institute on
contain sufficient facts to merit an FDA nih.gov. Aging Special Emphasis Panel; Primate
investigation, and must certify that a Name of Committee: National Center for Aging Database and Management.
true and complete copy of the petition Advancing Translational Sciences Special Date: March 1, 2018.
has been served upon the patent Emphasis Panel; Bench Testing. Time: 11:30 a.m. to 12:30 p.m.
Date: February 27, 2018. Agenda: To review and evaluate contract
applicant. (See H. Rept. 857, part 1, 98th Time: 8:00 a.m. to 5:30 p.m. proposals.
Cong., 2d sess., pp. 41–42, 1984.) Agenda: To review and evaluate grant Place: National Institute on Aging,
Petitions should be in the format applications, Gateway Building, Suite 2W233, 7201
specified in 21 CFR 10.30. Place: National Institutes of Health, Wisconsin Avenue, Bethesda, MD 20892
Democracy I, Room 1066, 6701 Democracy (Telephone Conference Call).
Submit petitions electronically to Contact Person: Anita H. Undale, Ph.D.,
Blvd., Bethesda, MD 20817 (Virtual Meeting).
https://www.regulations.gov at Docket
daltland on DSKBBV9HB2PROD with NOTICES

Contact Person: Barbara J. Nelson, Ph.D., MD, Scientific Review Branch, National
No. FDA–2013–S–0610. Submit written Scientific Review Officer, Office of Scientific Institute on Aging, Gateway Building, Suite
petitions (two copies are required) to the Review, National Center for Advancing 2W200, 7201 Wisconsin Avenue, Bethesda,
Dockets Management Staff (HFA–305), Translational Sciences (NCATS), National MD 20892, 240–747–7825, anita.undale@
Food and Drug Administration, 5630 Institutes of Health, 6701 Democracy Blvd., nih.gov.
Fishers Lane, Rm. 1061, Rockville, MD Democracy I, Room 1080, Bethesda, MD (Catalogue of Federal Domestic Assistance
20892–4874, 301–435–0806, nelsonbj@ Program Nos. 93.866, Aging Research,
20852. mail.nih.gov. National Institutes of Health, HHS)

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Document Created: 2018-10-26 10:12:24
Document Modified: 2018-10-26 10:12:24

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 April 2, 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 July 30, 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		83 FR 4224

83 FR 4224 - Determination of Regulatory Review Period for Purposes of Patent Extension; SAPIEN 3 TRANSCATHETER HEART VALVE

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 20 (January 30, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration