83_FR_62813 83 FR 62580 - Determination of Regulatory Review Period for Purposes of Patent Extension; ASPIRE ASSIST

83 FR 62580 - Determination of Regulatory Review Period for Purposes of Patent Extension; ASPIRE ASSIST

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 233 (December 4, 2018)

Page Range62580-62582
FR Document2018-26290

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ASPIRE ASSIST 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 medical device.

Federal Register, Volume 83 Issue 233 (Tuesday, December 4, 2018) 
[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)]
[Notices]
[Pages 62580-62582]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-26290]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-E-2801]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; ASPIRE ASSIST

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has 
determined the regulatory review period for ASPIRE ASSIST 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 
medical device.

DATES: Anyone with knowledge that any of the dates as published (see 
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either 
electronic or written comments and ask for a redetermination by 
February 4, 2019. 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 June 3, 2019. 
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more 
information.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before February 4, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 3, 2019. 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

[[Page 62581]]

identified, as confidential, if submitted as detailed in 
``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-E-2801 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; ASPIRE ASSIST.'' Received comments, those 
filed in a timely manner (see ADDRESSES), will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and 
other applicable disclosure law. For more information about FDA's 
posting of comments to public dockets, see 80 FR 56469, September 18, 
2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term 
Restoration Act (Pub. L. 100-670) generally provide that a patent may 
be extended for a period of up to 5 years so long as the patented item 
(human drug product, animal drug product, medical device, food 
additive, or color additive) was subject to regulatory review by FDA 
before the item was marketed. Under these acts, a product's regulatory 
review period forms the basis for determining the amount of extension 
an applicant may receive.
    A regulatory review period consists of two periods of time: a 
testing phase and an approval phase. For 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 ASPIRE ASSIST. 
ASPIRE ASSIST is indicated for use in adults aged 22 or older with a 
body mass index (BMI) of 35.0-55.0 kg/m2 who have failed to achieve and 
maintain weight loss with non-surgical weight loss therapy. The ASPIRE 
ASSIST is intended for a long-term duration of use in conjunction with 
lifestyle therapy and continuous medical monitoring. Subsequent to this 
approval, the USPTO received a patent term restoration application for 
ASPIRE ASSIST (U.S. Patent No. 9,039,677) from Aspire Bariatrics, Inc., 
and the USPTO requested FDA's assistance in determining this patent's 
eligibility for patent term restoration. In a letter dated October 16, 
2017, FDA advised the USPTO that this medical device had undergone a 
regulatory review period and that the approval of ASPIRE ASSIST 
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 
ASPIRE ASSIST is 2,785 days. Of this time, 2,444 days occurred during 
the testing phase of the regulatory review period, while 341 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 (FD&C Act) (21 U.S.C. 360j(g)) involving this 
device became effective: October 31, 2008. 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 May 
16, 2012. However, FDA records indicate that the IDE was determined 
substantially complete for clinical studies to have begun on October 
31, 2008, 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): July 10, 
2015. The applicant claims July 7, 2015, as the date the premarket 
approval application (PMA) for ASPIRE ASSIST (PMA P150024) was 
initially submitted. However, FDA records indicate that PMA P150024 was 
submitted on July 10, 2015.
    3. The date the application was approved: June 14, 2016. FDA has 
verified the applicant's claim that PMA P150024 was approved on June 
14, 2016.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the USPTO 
applies several statutory limitations in its calculations of the actual 
period for patent extension. In its application for patent extension, 
this applicant seeks 385 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

[[Page 62582]]

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: November 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26290 Filed 12-3-18; 8:45 am]
BILLING CODE 4164-01-P

62580 Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices prior authorization request with Additional information is available on Furthermore, any interested person may appropriate documentation. the CMS website at http://go.cms.gov/ petition FDA for a determination • Scenario 4: If an ambulance PAAmbulance. regarding whether the applicant for provider or supplier renders a service to extension acted with due diligence a beneficiary and does not request prior III. Collection of Information during the regulatory review period by authorization by the fourth round trip in Requirements June 3, 2019. See ‘‘Petitions’’ in the a 30-day period, and the claim is Section 1115A(d)(3) of the Act states SUPPLEMENTARY INFORMATION section for submitted to the MAC for payment, then that chapter 35 of title 44, United States more information. the claim will be stopped for Code (the Paperwork Reduction Act of ADDRESSES: You may submit comments prepayment review and documentation 1995), shall not apply to the testing and as follows. Please note that late, will be requested. evaluation of models or expansion of untimely filed comments will not be ++ If the claim is determined to be for such models under this section. considered. Electronic comments must services that were not medically Consequently, this document need not be submitted on or before February 4, necessary or for which there was be reviewed by the Office of 2019. The https://www.regulations.gov insufficient documentation, the claim Management and Budget under the electronic filing system will accept will be denied, and all current policies authority of the Paperwork Reduction comments until 11:59 p.m. Eastern Time and procedures regarding liability for Act of 1995. at the end of June 3, 2019. Comments payment will apply. The ambulance received by mail/hand delivery/courier provider/supplier or the beneficiary, or IV. Regulatory Impact Statement (for written/paper submissions) will be both, can appeal the claim denial if they This document announces a 1-year considered timely if they are believe the denial was inappropriate. extension of the Medicare Prior postmarked or the delivery service ++ If the claim is determined to be Authorization Model for Repetitive acceptance receipt is on or before that payable, it will be paid. Scheduled Non-Emergent Ambulance date. Only one prior authorization request Transport. Therefore, there are no per beneficiary per designated time regulatory impact implications Electronic Submissions period can be provisionally affirmed. If associated with this notice. Submit electronic comments in the the initial ambulance provider/supplier following way: Authority: Section 1115A of the Act. cannot complete the total number of • Federal eRulemaking Portal: prior authorized transports (for Dated: November 27, 2018. https://www.regulations.gov. Follow the example, the initial ambulance Seema Verma, instructions for submitting comments. company closes or no longer services Administrator, Centers for Medicare & Comments submitted electronically, that area), the initial request is Medicaid Services. including attachments, to https:// cancelled. In this situation, a [FR Doc. 2018–26334 Filed 11–30–18; 11:15 am] www.regulations.gov will be posted to subsequent prior authorization request BILLING CODE 4120–01–P the docket unchanged. Because your may be submitted for the same comment will be made public, you are beneficiary and must include the solely responsible for ensuring that your required documentation in the DEPARTMENT OF HEALTH AND comment does not include any submission. If multiple ambulance HUMAN SERVICES confidential information that you or a providers/suppliers are providing third party may not wish to be posted, transports to the beneficiary during the Food and Drug Administration such as medical information, your or same or overlapping time period, the [Docket No. FDA–2017–E–2801] anyone else’s Social Security number, or prior authorization decision will only confidential business information, such cover the ambulance provider/supplier Determination of Regulatory Review as a manufacturing process. Please note indicated in the provisionally affirmed Period for Purposes of Patent that if you include your name, contact prior authorization request. Any Extension; ASPIRE ASSIST information, or other information that ambulance provider/supplier submitting identifies you in the body of your claims for repetitive, scheduled non- AGENCY: Food and Drug Administration, HHS. comments, that information will be emergent ambulance transports for posted on https://www.regulations.gov. which no prior authorization request is ACTION: Notice. • If you want to submit a comment submitted by the fourth round trip in a with confidential information that you 30-day period will be subject to 100 SUMMARY: The Food and Drug Administration (FDA or the Agency) has do not wish to be made available to the percent prepayment medical review of public, submit the comment as a those claims. determined the regulatory review period for ASPIRE ASSIST and is publishing written/paper submission and in the Under the model, we will work to manner detailed (see ‘‘Written/Paper limit any adverse impact on this notice of that determination as required by law. FDA has made the Submissions’’ and ‘‘Instructions’’). beneficiaries and to educate beneficiaries about the process. If a prior determination because of the Written/Paper Submissions authorization request is non-affirmed, submission of an application to the Submit written/paper submissions as and the claim is still submitted by the Director of the U.S. Patent and follows: ambulance provider/supplier, the claim Trademark Office (USPTO), Department • Mail/Hand delivery/Courier (for will be denied, but beneficiaries will of Commerce, for the extension of a written/paper submissions): Dockets continue to have all applicable patent which claims that medical Management Staff (HFA–305), Food and administrative appeal rights. We have device. Drug Administration, 5630 Fishers also recently implemented a process to DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852. help find alternative resources for of the dates as published (see the • For written/paper comments beneficiaries who do not meet the SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management requirements of the Medicare repetitive incorrect may submit either electronic Staff, FDA will post your comment, as scheduled non-emergent ambulance or written comments and ask for a well as any attachments, except for transport benefit. redetermination by February 4, 2019. information submitted, marked and VerDate Sep<11>2014 17:36 Dec 03, 2018 Jkt 247001 PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 E:\FR\FM\04DEN1.SGM 04DEN1

Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices 62581 identified, as confidential, if submitted Rm. 6250, Silver Spring, MD 20993, requested that FDA determine the as detailed in ‘‘Instructions.’’ 301–796–3600. product’s regulatory review period. Instructions: All submissions received SUPPLEMENTARY INFORMATION: II. Determination of Regulatory Review must include the Docket No. FDA– I. Background Period 2017–E–2801 for ‘‘Determination of Regulatory Review Period for Purposes The Drug Price Competition and FDA has determined that the of Patent Extension; ASPIRE ASSIST.’’ Patent Term Restoration Act of 1984 applicable regulatory review period for Received comments, those filed in a (Pub. L. 98–417) and the Generic ASPIRE ASSIST is 2,785 days. Of this timely manner (see ADDRESSES), will be Animal Drug and Patent Term time, 2,444 days occurred during the placed in the docket and, except for Restoration Act (Pub. L. 100–670) testing phase of the regulatory review those submitted as ‘‘Confidential generally provide that a patent may be period, while 341 days occurred during Submissions,’’ publicly viewable at extended for a period of up to 5 years the approval phase. These periods of https://www.regulations.gov or at the so long as the patented item (human time were derived from the following Dockets Management Staff between 9 drug product, animal drug product, dates: a.m. and 4 p.m., Monday through medical device, food additive, or color 1. The date an exemption under Friday. additive) was subject to regulatory section 520(g) of the Federal Food, Drug, • Confidential Submissions—To review by FDA before the item was and Cosmetic Act (FD&C Act) (21 U.S.C. submit a comment with confidential marketed. Under these acts, a product’s 360j(g)) involving this device became information that you do not wish to be regulatory review period forms the basis effective: October 31, 2008. The made publicly available, submit your for determining the amount of extension applicant claims that the investigational comments only as a written/paper an applicant may receive. device exemption (IDE) required under submission. You should submit two A regulatory review period consists of section 520(g) of the FD&C Act for copies total. One copy will include the two periods of time: a testing phase and human tests to begin became effective information you claim to be confidential an approval phase. For medical devices, on May 16, 2012. However, FDA records with a heading or cover note that states the testing phase begins with a clinical indicate that the IDE was determined ‘‘THIS DOCUMENT CONTAINS investigation of the device and runs substantially complete for clinical CONFIDENTIAL INFORMATION.’’ The until the approval phase begins. The studies to have begun on October 31, Agency will review this copy, including approval phase starts with the initial 2008, which represents the IDE effective the claimed confidential information, in submission of an application to market date. its consideration of comments. The the device and continues until 2. The date an application was second copy, which will have the permission to market the device is initially submitted with respect to the claimed confidential information granted. Although only a portion of a device under section 515 of the FD&C redacted/blacked out, will be available regulatory review period may count Act (21 U.S.C. 360e): July 10, 2015. The for public viewing and posted on toward the actual amount of extension applicant claims July 7, 2015, as the https://www.regulations.gov. Submit that the Director of USPTO may award date the premarket approval application (half the testing phase must be (PMA) for ASPIRE ASSIST (PMA both copies to the Dockets Management subtracted as well as any time that may P150024) was initially submitted. Staff. If you do not wish your name and have occurred before the patent was However, FDA records indicate that contact information to be made publicly issued), FDA’s determination of the PMA P150024 was submitted on July available, you can provide this length of a regulatory review period for 10, 2015. information on the cover sheet and not a medical device will include all of the 3. The date the application was in the body of your comments and you testing phase and approval phase as approved: June 14, 2016. FDA has must identify this information as specified in 35 U.S.C. 156(g)(3)(B). verified the applicant’s claim that PMA ‘‘confidential.’’ Any information marked FDA has approved for marketing the P150024 was approved on June 14, as ‘‘confidential’’ will not be disclosed medical device ASPIRE ASSIST. 2016. except in accordance with § 10.20 (21 ASPIRE ASSIST is indicated for use in This determination of the regulatory CFR 10.20) and other applicable adults aged 22 or older with a body review period establishes the maximum disclosure law. For more information mass index (BMI) of 35.0–55.0 kg/m2 potential length of a patent extension. about FDA’s posting of comments to who have failed to achieve and maintain However, the USPTO applies several public dockets, see 80 FR 56469, weight loss with non-surgical weight statutory limitations in its calculations September 18, 2015, or access the loss therapy. The ASPIRE ASSIST is of the actual period for patent extension. information at: https://www.gpo.gov/ intended for a long-term duration of use In its application for patent extension, fdsys/pkg/FR-2015-09-18/pdf/2015- in conjunction with lifestyle therapy this applicant seeks 385 days of patent 23389.pdf. and continuous medical monitoring. term extension. Docket: For access to the docket to Subsequent to this approval, the USPTO read background documents or the received a patent term restoration III. Petitions electronic and written/paper comments application for ASPIRE ASSIST (U.S. Anyone with knowledge that any of received, go to https:// Patent No. 9,039,677) from Aspire the dates as published are incorrect may www.regulations.gov and insert the Bariatrics, Inc., and the USPTO submit either electronic or written docket number, found in brackets in the requested FDA’s assistance in comments and, under 21 CFR 60.24, ask heading of this document, into the determining this patent’s eligibility for for a redetermination (see DATES). ‘‘Search’’ box and follow the prompts patent term restoration. In a letter dated Furthermore, as specified in § 60.30 (21 and/or go to the Dockets Management October 16, 2017, FDA advised the CFR 60.30), any interested person may Staff, 5630 Fishers Lane, Rm. 1061, USPTO that this medical device had petition FDA for a determination Rockville, MD 20852. undergone a regulatory review period regarding whether the applicant for FOR FURTHER INFORMATION CONTACT: and that the approval of ASPIRE extension acted with due diligence Beverly Friedman, Office of Regulatory ASSIST represented the first permitted during the regulatory review period. To Policy, Food and Drug Administration, commercial marketing or use of the meet its burden, the petition must 10903 New Hampshire Ave., Bldg. 51, product. Thereafter, the USPTO comply with all the requirements of VerDate Sep<11>2014 17:36 Dec 03, 2018 Jkt 247001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\FR\FM\04DEN1.SGM 04DEN1

62582 Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices § 60.30, including but not limited to: Comments submitted electronically, claimed confidential information Must be timely (see DATES), must be including attachments, to https:// redacted/blacked out, will be available filed in accordance with § 10.20, must www.regulations.gov will be posted to for public viewing and posted on contain sufficient facts to merit an FDA the docket unchanged. Because your https://www.regulations.gov. Submit investigation, and must certify that a comment will be made public, you are both copies to the Dockets Management true and complete copy of the petition solely responsible for ensuring that your Staff. If you do not wish your name and has been served upon the patent comment does not include any contact information to be made publicly applicant. (See H. Rept. 857, part 1, 98th confidential information that you or a available, you can provide this Cong., 2d sess., pp. 41–42, 1984.) third party may not wish to be posted, information on the cover sheet and not Petitions should be in the format such as medical information, your or in the body of your comments and you specified in 21 CFR 10.30. anyone else’s Social Security number, or must identify this information as Submit petitions electronically to confidential business information, such ‘‘confidential.’’ Any information marked https://www.regulations.gov at Docket as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed No. FDA–2013–S–0610. Submit written that if you include your name, contact except in accordance with 21 CFR 10.20 petitions (two copies are required) to the information, or other information that and other applicable disclosure law. For Dockets Management Staff (HFA–305), identifies you in the body of your more information about FDA’s posting Food and Drug Administration, 5630 comments, that information will be of comments to public dockets, see 80 Fishers Lane, Rm. 1061, Rockville, MD posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access 20852. • If you want to submit a comment the information at: https://www.gpo.gov/ with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015- Dated: November 28, 2018. do not wish to be made available to the 23389.pdf. Leslie Kux, public, submit the comment as a Docket: For access to the docket to Associate Commissioner for Policy. written/paper submission and in the read background documents or the [FR Doc. 2018–26290 Filed 12–3–18; 8:45 am] manner detailed (see ‘‘Written/Paper electronic and written/paper comments BILLING CODE 4164–01–P Submissions’’ and ‘‘Instructions’’). received, go to https:// Written/Paper Submissions www.regulations.gov and insert the docket number, found in brackets in the DEPARTMENT OF HEALTH AND Submit written/paper submissions as heading of this document, into the HUMAN SERVICES follows: ‘‘Search’’ box and follow the prompts • Mail/Hand delivery/Courier (for Food and Drug Administration and/or go to the Dockets Management written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061, [Docket No. FDA–2018–D–3632] Management Staff (HFA–305), Food and Rockville, MD 20852. Drug Administration, 5630 Fishers You may submit comments on any Noncirrhotic Nonalcoholic Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments guidance at any time (see 21 CFR Steatohepatitis With Liver Fibrosis: 10.115(g)(5)). Developing Drugs for Treatment; Draft submitted to the Dockets Management Staff, FDA will post your comment, as Submit written requests for single Guidance for Industry; Availability copies of the draft guidance to the well as any attachments, except for AGENCY: Food and Drug Administration, information submitted, marked and Division of Drug Information, Center for HHS. identified, as confidential, if submitted Drug Evaluation and Research, Food ACTION: Notice of availability. as detailed in ‘‘Instructions.’’ and Drug Administration, 10001 New Instructions: All submissions received Hampshire Ave., Hillandale Building, SUMMARY: The Food and Drug must include the Docket No. FDA– 4th Floor, Silver Spring, MD 20993– Administration (FDA or Agency) is 2018–D–3632 for ‘‘Noncirrhotic 0002. Send one self-addressed adhesive announcing the availability of a draft Nonalcoholic Steatohepatitis With Liver label to assist that office in processing guidance for industry entitled Fibrosis: Developing Drugs for your requests. See the SUPPLEMENTARY ‘‘Noncirrhotic Nonalcoholic Treatment.’’ Received comments will be INFORMATION section for electronic Steatohepatitis With Liver Fibrosis: placed in the docket and, except for access to the draft guidance document. Developing Drugs for Treatment.’’ This those submitted as ‘‘Confidential FOR FURTHER INFORMATION CONTACT: draft guidance is intended to assist Submissions,’’ publicly viewable at Evangela Covert, Center for Drug sponsors in the clinical development of https://www.regulations.gov or at the Evaluation and Research, Food and drugs for the treatment of noncirrhotic Dockets Management Staff between 9 Drug Administration, 10903 New nonalcoholic steatohepatitis (NASH) a.m. and 4 p.m., Monday through Hampshire Ave., Bldg. 22, Rm. 5234, with liver fibrosis. Friday. Silver Spring, MD 20993–0002, 301– DATES: Submit either electronic or • Confidential Submissions—To 796–4075. written comments on the draft guidance submit a comment with confidential SUPPLEMENTARY INFORMATION: by February 4, 2019 to ensure that the information that you do not wish to be Agency considers your comment on this made publicly available, submit your I. Background draft guidance before it begins work on comments only as a written/paper FDA is announcing the availability of the final version of the guidance. submission. You should submit two a draft guidance for industry entitled ADDRESSES: You may submit comments copies total. One copy will include the ‘‘Noncirrhotic Nonalcoholic on any guidance at any time as follows: information you claim to be confidential Steatohepatitis With Liver Fibrosis: with a heading or cover note that states Developing Drugs for Treatment.’’ This Electronic Submissions ‘‘THIS DOCUMENT CONTAINS draft guidance is intended to assist Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The sponsors in the clinical development of following way: Agency will review this copy, including drugs for the treatment of noncirrhotic • Federal eRulemaking Portal: the claimed confidential information, in NASH with liver fibrosis. The draft https://www.regulations.gov. Follow the its consideration of comments. The guidance also identifies knowledge gaps instructions for submitting comments. second copy, which will have the that represent important challenges in VerDate Sep<11>2014 17:36 Dec 03, 2018 Jkt 247001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\FR\FM\04DEN1.SGM 04DEN1


Document Created: 2018-12-04 00:43:02
Document Modified: 2018-12-04 00:43:02
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAnyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by February 4, 2019. 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 June 3, 2019. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information.
ContactBeverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
FR Citation83 FR 62580 
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