82_FR_39747 82 FR 39587 - Determination of Regulatory Review Period for Purposes of Patent Extension; RECUVYRA

82 FR 39587 - Determination of Regulatory Review Period for Purposes of Patent Extension; RECUVYRA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 160 (August 21, 2017)

Page Range39587-39589
FR Document2017-17566

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

Federal Register, Volume 82 Issue 160 (Monday, August 21, 2017) 
[Federal Register Volume 82, Number 160 (Monday, August 21, 2017)]
[Notices]
[Pages 39587-39589]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-17566]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2013-E-0264; FDA-2013-E-0263; and FDA-2013-E-0218]


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

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 RECUVYRA 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 animal 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 
20, 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 20, 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 20, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of October 20, 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:
     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 39588]]

identified, as confidential, if submitted as detailed in 
``Instructions.''
    Instructions: All submissions received must include the Docket Nos. 
FDA-2013-E-0264; FDA-2013-E-0263; and FDA-2013-E-0218 for 
``Determination of Regulatory Review Period for Purposes of Patent 
Extension; RECUVYRA.'' 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 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 animal drug products, the 
testing phase begins on the earlier date when either a major 
environmental effects test was initiated for the drug or when an 
exemption under section 512(j) of the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) (21 U.S.C. 360b(j)) became effective and runs until 
the approval phase begins. The approval phase starts with the initial 
submission of an application to market the animal 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 an animal 
drug product will include all of the testing phase and approval phase 
as specified in 35 U.S.C. 156(g)(4)(B).
    FDA has approved for marketing the animal drug product RECUVYRA 
(fentanyl). RECUVYRA is indicated for the control of postoperative pain 
associated with surgical procedures in dogs. Subsequent to this 
approval, the USPTO received patent term restoration applications for 
RECUVYRA (U.S. Patent Nos. 6,299,900; 6,818,226; and 6,916,486) from 
Acrux DDS Pty. Ltd., and the USPTO requested FDA's assistance in 
determining the patents' eligibility for patent term restoration. In a 
letter dated April 26, 2016, FDA advised the USPTO that this animal 
drug product had undergone a regulatory review period and that the 
approval of RECUVYRA 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 
RECUVYRA is 2,092 days. Of this time, 2,037 days occurred during the 
testing phase of the regulatory review period, while 55 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 FD&C Act (21 
U.S.C. 355(i)) became effective: October 3, 2006. The applicant claims 
August 31, 2005, as the date the investigational new animal drug 
application (INAD) became effective. However, FDA records indicate that 
the INAD effective date was October 3, 2006, which was the date a major 
health or environmental effects test began.
    2. The date the application was initially submitted with respect to 
the animal drug product under section 512 of the FD&C Act (21 U.S.C. 
360b): April 30, 2012. The applicant claims April 18, 2012, as the date 
the new animal drug application (NADA) for RECUVYRA (NADA 141-337) was 
initially submitted. However, FDA records indicate that NADA 141-337 
was submitted on April 30, 2012.
    3. The date the application was approved: June 23, 2012. FDA has 
verified the applicant's claim that NADA 141-337 was approved on June 
23, 2012.
    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 1,279 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 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 be timely (see DATES) and contain sufficient facts to 
merit an FDA investigation. (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.

[[Page 39589]]

    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 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17566 Filed 8-18-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Notices 39587 structure in order to (1) improve the and (5) incorporate advances in survey in short, Web-based methodological and measurement of covered health topics, methodology and measurement. cognitive testing activities to evaluate (2) reduce respondent burden by As in past years, and in accordance the redesigned questionnaire and/or shortening the length of the with the 1995 initiative to increase the inform the development of new rotating questionnaire and seamlessly integration of surveys within the DHHS, and supplemental content using Web integrating supplements, (3) harmonize respondents to the 2018 NHIS will serve and/or mail survey tools. overlapping content with other federal as the sampling frame for the Medical Expenditure Panel Survey. In addition, There is no cost to the respondents health surveys, (4) establish a long-term other than their time. Clearance is a subsample of NHIS respondents and/ structure of ongoing and periodic topics, sought for three years, to collect data for or members of commercial survey panels may be identified to participate 2018–2020. ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Number of burden per Total burden Type of respondent Form name responses per respondents response (in hours) respondent (in hours) Adult Household Member ................. Main Household Composition and 39,375 1 23/60 15,094 Family Core. Sample Adult ..................................... Main Adult Core ............................... 31,500 1 15/60 7,875 Adult Family Member ........................ Main Child Core ............................... 12,250 1 10/60 2,042 Adult Family Member ........................ Main Supplements ........................... 45,000 1 20/60 15,000 Adult Household Member ................. Redesigned Family Core ................. 5,625 1 23/60 2,156 Sample Adult ..................................... Redesigned Adult Core .................... 4,500 1 15/60 1,125 Adult Family Member ........................ Redesigned Child Core .................... 1,750 1 10/60 292 Adult Family Member ........................ Methodological Projects ................... 15,000 1 20/60 5,000 Adult Family Member ........................ Reinterview Survey .......................... 5,000 1 5/60 417 Total ........................................... ........................................................... ........................ ........................ ........................ 49,000 Leroy A. Richardson, DATES: Anyone with knowledge that any including attachments, to https:// Chief, Information Collection Review Office, of the dates as published (in the www.regulations.gov will be posted to Office of Scientific Integrity, Office of the SUPPLEMENTARY INFORMATION section) are the docket unchanged. Because your Associate Director for Science, Office of the incorrect may submit either electronic comment will be made public, you are Director, Centers for Disease Control and or written comments and ask for a solely responsible for ensuring that your Prevention. redetermination by October 20, 2017. comment does not include any [FR Doc. 2017–17582 Filed 8–18–17; 8:45 am] Furthermore, any interested person may confidential information that you or a BILLING CODE 4163–18–P petition FDA for a determination third party may not wish to be posted, regarding whether the applicant for such as medical information, your or extension acted with due diligence anyone else’s Social Security number, or DEPARTMENT OF HEALTH AND during the regulatory review period by confidential business information, such HUMAN SERVICES February 20, 2018. See ‘‘Petitions’’ in as a manufacturing process. Please note the SUPPLEMENTARY INFORMATION section that if you include your name, contact Food and Drug Administration information, or other information that for more information. [Docket Nos. FDA–2013–E–0264; FDA– ADDRESSES: You may submit comments identifies you in the body of your 2013–E–0263; and FDA–2013–E–0218] comments, that information will be as follows. Please note that late, posted on https://www.regulations.gov. untimely filed comments will not be Determination of Regulatory Review • If you want to submit a comment considered. Electronic comments must with confidential information that you Period for Purposes of Patent be submitted on or before October 20, Extension; RECUVYRA do not wish to be made available to the 2017. The https://www.regulations.gov public, submit the comment as a AGENCY: Food and Drug Administration, electronic filing system will accept written/paper submission and in the HHS. comments until midnight Eastern Time manner detailed (see ‘‘Written/Paper ACTION: Notice. at the end of October 20, 2017. Submissions’’ and ‘‘Instructions’’). Comments received by mail/hand SUMMARY: The Food and Drug delivery/courier (for written/paper Written/Paper Submissions Administration (FDA or the Agency) has submissions) will be considered timely Submit written/paper submissions as determined the regulatory review period if they are postmarked or the delivery follows: for RECUVYRA and is publishing this service acceptance receipt is on or • Mail/Hand delivery/Courier (for before that date. asabaliauskas on DSKBBXCHB2PROD with NOTICES notice of that determination as required written/paper submissions): Dockets by law. FDA has made the Electronic Submissions Management Staff (HFA–305), Food and determination because of the Drug Administration, 5630 Fishers submission of applications to the Submit electronic comments in the Lane, Rm. 1061, Rockville, MD 20852. Director of the U.S. Patent and following way: • For written/paper comments Trademark Office (USPTO), Department • Federal eRulemaking Portal: submitted to the Dockets Management of Commerce, for the extension of a https://www.regulations.gov. Follow the Staff, FDA will post your comment, as patent which claims that animal drug instructions for submitting comments. well as any attachments, except for product. Comments submitted electronically, information submitted, marked and VerDate Sep<11>2014 18:37 Aug 18, 2017 Jkt 241001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\21AUN1.SGM 21AUN1

39588 Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Notices identified, as confidential, if submitted Rm. 6250, Silver Spring, MD 20993, USPTO requested that FDA determine as detailed in ‘‘Instructions.’’ 301–796–3600. the product’s regulatory review period. Instructions: All submissions received SUPPLEMENTARY INFORMATION: II. Determination of Regulatory Review must include the Docket Nos. FDA– I. Background Period 2013–E–0264; FDA–2013–E–0263; and FDA–2013–E–0218 for ‘‘Determination The Drug Price Competition and FDA has determined that the of Regulatory Review Period for Patent Term Restoration Act of 1984 applicable regulatory review period for Purposes of Patent Extension; (Pub. L. 98–417) and the Generic RECUVYRA is 2,092 days. Of this time, RECUVYRA.’’ Received comments, Animal Drug and Patent Term 2,037 days occurred during the testing those filed in a timely manner (see Restoration Act (Pub. L. 100–670) phase of the regulatory review period, ADDRESSES), will be placed in the docket generally provide that a patent may be while 55 days occurred during the and, except for those submitted as extended for a period of up to 5 years approval phase. These periods of time ‘‘Confidential Submissions,’’ publicly so long as the patented item (human were derived from the following dates: viewable at https://www.regulations.gov drug product, animal drug product, 1. The date an exemption under or at the Dockets Management Staff medical device, food additive, or color section 505(i) of the FD&C Act (21 between 9 a.m. and 4 p.m., Monday additive) was subject to regulatory U.S.C. 355(i)) became effective: October through Friday. review by FDA before the item was 3, 2006. The applicant claims August • Confidential Submissions—To marketed. Under these acts, a product’s 31, 2005, as the date the investigational submit a comment with confidential regulatory review period forms the basis new animal drug application (INAD) information that you do not wish to be for determining the amount of extension became effective. However, FDA records made publicly available, submit your an applicant may receive. indicate that the INAD effective date comments only as a written/paper A regulatory review period consists of was October 3, 2006, which was the submission. You should submit two two periods of time: A testing phase and date a major health or environmental copies total. One copy will include the an approval phase. For animal drug effects test began. information you claim to be confidential products, the testing phase begins on 2. The date the application was with a heading or cover note that states the earlier date when either a major initially submitted with respect to the ‘‘THIS DOCUMENT CONTAINS environmental effects test was initiated animal drug product under section 512 CONFIDENTIAL INFORMATION.’’ The for the drug or when an exemption of the FD&C Act (21 U.S.C. 360b): April Agency will review this copy, including under section 512(j) of the Federal Food, 30, 2012. The applicant claims April 18, the claimed confidential information, in Drug, and Cosmetic Act (the FD&C Act) 2012, as the date the new animal drug its consideration of comments. The (21 U.S.C. 360b(j)) became effective and application (NADA) for RECUVYRA second copy, which will have the runs until the approval phase begins. (NADA 141–337) was initially claimed confidential information The approval phase starts with the submitted. However, FDA records redacted/blacked out, will be available initial submission of an application to indicate that NADA 141–337 was for public viewing and posted on market the animal drug product and submitted on April 30, 2012. continues until FDA grants permission 3. The date the application was https://www.regulations.gov. Submit to market the drug product. Although approved: June 23, 2012. FDA has both copies to the Dockets Management only a portion of a regulatory review verified the applicant’s claim that Staff. If you do not wish your name and period may count toward the actual NADA 141–337 was approved on June contact information to be made publicly amount of extension that the Director of 23, 2012. available, you can provide this This determination of the regulatory USPTO may award (for example, half information on the cover sheet and not review period establishes the maximum the testing phase must be subtracted as in the body of your comments and you potential length of a patent extension. well as any time that may have occurred must identify this information as However, the USPTO applies several before the patent was issued), FDA’s ‘‘confidential.’’ Any information marked statutory limitations in its calculations determination of the length of a as ‘‘confidential’’ will not be disclosed regulatory review period for an animal of the actual period for patent extension. except in accordance with 21 CFR 10.20 drug product will include all of the In its applications for patent extension, and other applicable disclosure law. For testing phase and approval phase as this applicant seeks 1,279 days of patent more information about FDA’s posting specified in 35 U.S.C. 156(g)(4)(B). term extension. of comments to public dockets, see 80 FDA has approved for marketing the FR 56469, September 18, 2015, or access animal drug product RECUVYRA III. Petitions the information at: https://www.gpo.gov/ (fentanyl). RECUVYRA is indicated for Anyone with knowledge that any of fdsys/pkg/FR-2015-09-18/pdf/2015- the control of postoperative pain the dates as published are incorrect may 23389.pdf. associated with surgical procedures in submit either electronic or written Docket: For access to the docket to dogs. Subsequent to this approval, the comments and, under 21 CFR 60.24, ask read background documents or the USPTO received patent term restoration for a redetermination (see DATES). electronic and written/paper comments applications for RECUVYRA (U.S. Furthermore, as specified in 21 CFR received, go to https:// Patent Nos. 6,299,900; 6,818,226; and 60.30, any interested person may www.regulations.gov and insert the 6,916,486) from Acrux DDS Pty. Ltd., petition FDA for a determination docket number, found in brackets in the and the USPTO requested FDA’s regarding whether the applicant for heading of this document, into the asabaliauskas on DSKBBXCHB2PROD with NOTICES assistance in determining the patents’ extension acted with due diligence ‘‘Search’’ box and follow the prompts eligibility for patent term restoration. In during the regulatory review period. To and/or go to the Dockets Management a letter dated April 26, 2016, FDA meet its burden, the petition must be Staff, 5630 Fishers Lane, Rm. 1061, advised the USPTO that this animal timely (see DATES) and contain sufficient Rockville, MD 20852. drug product had undergone a facts to merit an FDA investigation. (See FOR FURTHER INFORMATION CONTACT: regulatory review period and that the H. Rept. 857, part 1, 98th Cong., 2d Beverly Friedman, Office of Regulatory approval of RECUVYRA represented the sess., pp. 41–42, 1984.) Petitions should Policy, Food and Drug Administration, first permitted commercial marketing or be in the format specified in 21 CFR 10903 New Hampshire Ave., Bldg. 51, use of the product. Thereafter, the 10.30. VerDate Sep<11>2014 18:37 Aug 18, 2017 Jkt 241001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\21AUN1.SGM 21AUN1

Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Notices 39589 Submit petitions electronically to default.htm. The eStudy Data guidance ACTION: Notice of availability. https://www.regulations.gov at Docket implements the electronic submission No. FDA–2013–S–0610. Submit written requirements of section 745A(a) of the SUMMARY: The Food and Drug petitions (two copies are required) to the Food, Drug and Cosmetic Act (21 U.S.C. Administration (FDA or Agency) is Dockets Management Staff (HFA–305), 379k–1(a)) for study data contained in announcing the availability of a draft Food and Drug Administration, 5630 new drug applications (NDAs), guidance for industry entitled Fishers Lane, Rm. 1061, Rockville, MD abbreviated new drug applications ‘‘Identifying Trading Partners Under the 20852. (ANDAs), biologics license applications Drug Supply Chain Security Act’’ (draft (BLAs), and investigational new drug trading partner guidance). FDA is Dated: August 15, 2015. applications (INDs) to FDA’s Center for issuing this guidance to assist industry Leslie Kux, and State and local governments in Biologics Evaluation and Research or Associate Commissioner for Policy. CDER by specifying the format for understanding how to categorize the [FR Doc. 2017–17566 Filed 8–18–17; 8:45 am] electronic submissions. The initial entities in the drug supply chain in BILLING CODE 4164–01–P timetable for implementing electronic accordance with the Drug Supply Chain submission requirements for study data Security Act (DSCSA). This guidance was December 17, 2016 (24 months after explains how to determine when certain DEPARTMENT OF HEALTH AND issuance of final guidance for NDAs, statutory requirements will apply to HUMAN SERVICES BLAs, ANDAs, and 36 months for INDs). entities that may be considered trading The eStudy Data guidance states that a partners in the drug supply chain. FDA Food and Drug Administration is also soliciting public input specific to Federal Register notice will specify the [Docket No. FDA–2017–N–2363] transition date for all version updates the activities of ‘‘private-label (with the month and day for the distributors’’ of drug products and Electronic Study Data Submission; transition date corresponding to March whether those activities fall within the Data Standards; Support for Standard 15). definitions under DSCSA of the various for Exchange of Nonclinical Data The transition date for support of trading partners. Implementation Guide Version 3.1 version 3.1 of CDISC SEND IG is March DATES: Although you can comment on 15, 2018. Although SEND IG version 3.1 any guidance at any time (see 21 CFR AGENCY: Food and Drug Administration, is supported as of this Federal Register 10.115(g)(5)), to ensure that the Agency HHS. notice and sponsors or applicants are considers your comment on this draft ACTION: Notice. encouraged to begin using it, the new guidance before it begins work on the SUMMARY: The Food and Drug version will only be required in final version of the guidance, submit Administration’s (FDA or Agency) submissions for studies that start after either electronic or written comments Center for Drug Evaluation and Research March 15, 2019. The Catalog will list on the draft guidance by October 20, (CDER) is announcing support for the March 15, 2019, as the ‘‘date 2017. 3.1 version of Clinical Data Interchange requirement begins.’’ When multiple versions of an FDA-supported standard ADDRESSES: You may submit comments Standards Consortium (CDISC) Standard as follows: for Exchange of Nonclinical Data (SEND are listed in the Catalog, sponsors or IG 3.1), the end of support for the 3.0 applicants can select a version to use. Electronic Submissions The transition date for the end of FDA version of SEND IG, and an update to Submit electronic comments in the support for SEND IG 3.0 is March 15, the FDA Data Standards Catalog following way: 2018. Therefore, FDA support for SEND (Catalog). (See http://www.fda.gov/ IG 3.0 will end for studies that start after • Federal eRulemaking Portal: forindustry/datastandards/ https://www.regulations.gov. Follow the March 15, 2019. The Catalog will be studydatastandards/default.htm.) SEND instructions for submitting comments. updated to list March 15, 2019, as the IG 3.1 has been available from CDISC Comments submitted electronically, ‘‘date support ends.’’ (www.cdisc.org) since July 2016. FDA is including attachments, to https:// encouraging sponsors and applicants to II. Electronic Access www.regulations.gov will be posted to use SEND IG 3.1 in investigational study Persons with access to the Internet the docket unchanged. Because your data provided in regulatory submissions may obtain the referenced material at comment will be made public, you are to CDER. https://www.fda.gov/ectd. solely responsible for ensuring that your FOR FURTHER INFORMATION CONTACT: Ron Dated: August 15, 2017. comment does not include any Fitzmartin, Center for Drug Evaluation confidential information that you or a Leslie Kux, and Research, Food and Drug third party may not wish to be posted, Associate Commissioner for Policy. Administration, 10903 New Hampshire such as medical information, your or [FR Doc. 2017–17567 Filed 8–18–17; 8:45 am] Ave., Bldg. 51, Rm. 1115, Silver Spring, anyone else’s Social Security number, or MD 20993–0002, 301–796–5333, email: BILLING CODE 4164–01–P confidential business information, such CDERDataStandards@fda.hhs.gov. as a manufacturing process. Please note SUPPLEMENTARY INFORMATION: that if you include your name, contact DEPARTMENT OF HEALTH AND information, or other information that I. Background HUMAN SERVICES identifies you in the body of your asabaliauskas on DSKBBXCHB2PROD with NOTICES On December 17, 2014, FDA Food and Drug Administration comments, that information will be published final guidance for industry posted on https://www.regulations.gov. entitled ‘‘Providing Regulatory [Docket No. FDA–2017–D–1956] • If you want to submit a comment Submissions in Electronic Format— with confidential information that you Identifying Trading Partners Under the Standardized Study Data’’ (eStudy do not wish to be made available to the Drug Supply Chain Security Act; Draft Data), posted on FDA’s Study Data public, submit the comment as a Guidance for Industry; Availability Standards Resources Web page at written/paper submission and in the https://www.fda.gov/forindustry/ AGENCY: Food and Drug Administration, manner detailed (see ‘‘Written/Paper datastandards/studydatastandards/ HHS. Submissions’’ and ‘‘Instructions’’). VerDate Sep<11>2014 18:37 Aug 18, 2017 Jkt 241001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\21AUN1.SGM 21AUN1


Document Created: 2017-08-19 00:44:33
Document Modified: 2017-08-19 00:44:33
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 October 20, 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 20, 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 Citation82 FR 39587 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR