81_FR_86203 81 FR 85974 - Determination of Regulatory Review Period for Purposes of Patent Extension; NUWIQ

81 FR 85974 - Determination of Regulatory Review Period for Purposes of Patent Extension; NUWIQ

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 229 (November 29, 2016)

Page Range85974-85976
FR Document2016-28654

The Food and Drug Administration (FDA) has determined the regulatory review period for NUWIQ and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

Federal Register, Volume 81 Issue 229 (Tuesday, November 29, 2016) 
[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)]
[Notices]
[Pages 85974-85976]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-28654]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-0622]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for NUWIQ and is publishing this notice of 
that determination as required by law. FDA has made the determination 
because of the submission of an application to the Director of the U.S. 
Patent and Trademark Office (USPTO), Department of Commerce, for the 
extension of a patent which claims that human biological product.

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 January 
30, 2017. Furthermore, any interested person may petition FDA for a 
determination regarding whether the applicant for extension acted with 
due diligence during the regulatory review period by May 30, 2017. See 
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more 
information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted,

[[Page 85975]]

marked and identified, as confidential, if submitted as detailed in 
``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-E-0622 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; NUWIQ.'' Received comments will be placed 
in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

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

SUPPLEMENTARY INFORMATION: 

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term 
Restoration Act (Pub. L. 100-670) generally provide that a patent may 
be extended for a period of up to 5 years so long as the patented item 
(human drug product, animal drug product, medical device, food 
additive, or color additive) was subject to regulatory review by FDA 
before the item was marketed. Under these acts, a product's regulatory 
review period forms the basis for determining the amount of extension 
an applicant may receive.
    A regulatory review period consists of two periods of time: A 
testing phase and an approval phase. For human biological products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the biological becomes effective and runs until the 
approval phase begins. The approval phase starts with the initial 
submission of an application to market the human biological product and 
continues until FDA grants permission to market the biological product. 
Although only a portion of a regulatory review period may count toward 
the actual amount of extension that the Director of USPTO may award 
(for example, half the testing phase must be subtracted as well as any 
time that may have occurred before the patent was issued), FDA's 
determination of the length of a regulatory review period for a human 
biological product will include all of the testing phase and approval 
phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human biologic product NUWIQ 
(Antihemophilic Factor (Recombinant)). NUWIQ is indicated for adults 
and children with Hemophilia A for:
     On-demand treatment and control of bleeding episodes;
     perioperative management of bleeding;
     routine prophylaxis to reduce the frequency of bleeding 
episodes.

Subsequent to this approval, the USPTO received a patent term 
restoration application for NUWIQ (U.S. Patent No. 7,572,619) from 
Octapharma AG, and the USPTO requested FDA's assistance in determining 
this patent's eligibility for patent term restoration. In a letter 
dated April 20, 2016, FDA advised the USPTO that this human biological 
product had undergone a regulatory review period and that the approval 
of NUWIQ 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 
NUWIQ is 2,622 days. Of this time, 2,165 days occurred during the 
testing phase of the regulatory review period, while 457 days occurred 
during the approval phase. These periods of time were derived from the 
following dates:
    1. The date an exemption under section 505(i) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: July 2, 
2008. FDA has verified the applicant's claim that the date the 
investigational new drug application became effective was on July 2, 
2008.
    2. The date the application was initially submitted with respect to 
the human biological product under section 351 of the Public Health 
Service Act (42 U.S.C. 262): June 5, 2014. FDA has verified the 
applicant's claim that the biologics license application (BLA) for 
NUWIQ (BLA 125555/0) was initially submitted on June 5, 2014.
    3. The date the application was approved: September 4, 2015. FDA 
has verified the applicant's claim that BLA 125555/0 was approved on 
September 4, 2015.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the USPTO 
applies several statutory limitations in its calculations of the actual 
period for patent extension. In its application for patent extension, 
this applicant seeks 1,336 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 ask for 
a redetermination (see DATES). 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. 
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.
    Submit petitions electronically to http://www.regulations.gov at 
Docket No. FDA-2013-S-0610. Submit written

[[Page 85976]]

petitions (two copies are required) to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

    Dated: November 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28654 Filed 11-28-16; 8:45 am]
 BILLING CODE 4164-01-P

85974 Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices Guidance for Industry on Expedited programs’ policies and procedures and submit to FDA as part of the application Programs for Serious Conditions— describes applicable threshold criteria, (totaling 2,400 hours). Drugs and Biologics OMB Control including when to submit information Breakthrough Therapy Designation Number 0910–0765—Extension to FDA. Respondents to the information Request. The guidance describes the collection are sponsors of drug and process for sponsors to request FDA has established four programs biological products appropriate for these intended to facilitate and expedite breakthrough therapy designation in an expedited programs. development and review of new drugs application. Based on information from Priority Review Designation Request. to address unmet medical needs in the The guidance describes that a sponsor FDA’s databases and information treatment of serious or life-threatening may expressly request priority review of available to FDA, we estimate that conditions: (1) Fast track designation an application. Based on information approximately 87 sponsors will prepare including rolling review, (2) from FDA’s databases and information approximately 1.29 breakthrough breakthrough therapy designation, (3) available to FDA, we estimate that therapy designation submissions in accelerated approval, and (4) priority approximately 48 sponsors will prepare accordance with the guidance and that review designation. In support of these and submit approximately 1.7 priority the added burden for each submission programs, the Agency has developed the review designation submissions that will be approximately 70 hours to guidance document, ‘‘Guidance For receive a priority review in accordance prepare and submit (totaling 7,910 Industry: Expedited Programs for with the guidance and that the added hours). Serious Conditions—Drugs and burden for each submission will be Accordingly, we estimate the burden Biologics.’’ The guidance outlines the approximately 30 hours to develop and of this information collection as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Average Number of Total annual Guidance on expedited programs responses per burden per Total hours respondents responses respondent response Priority Review Designation Request .................................. 48 1.7 80 30 2,400 Breakthrough Therapy Designation Request ...................... 87 1.29 113 70 7,910 Total .............................................................................. ........................ ........................ ........................ ........................ 10,310 1 There are no capital costs or operating and maintenance costs associated with the information collection. The guidance also refers to previously and is publishing this notice of that the docket unchanged. Because your approved collections of information determination as required by law. FDA comment will be made public, you are found in FDA regulations. The has made the determination because of solely responsible for ensuring that your collections of information in 21 CFR the submission of an application to the comment does not include any parts 202.1, 314, and 601, and sections Director of the U.S. Patent and confidential information that you or a 505(a), 506(a)(1), 735, and 736 of the Trademark Office (USPTO), Department third party may not wish to be posted, Federal Food, Drug, and Cosmetic Act of Commerce, for the extension of a such as medical information, your or (21 U.S.C. 355(a), 356(a)(1), 379(g), and patent which claims that human anyone else’s Social Security number, or 379(h)) have been approved under OMB biological product. confidential business information, such control numbers 0910–0686, 0910–0001, DATES: Anyone with knowledge that any as a manufacturing process. Please note 0910–0338, 0910–0014, and 0910–0297. of the dates as published (see the that if you include your name, contact Dated: November 22, 2016. SUPPLEMENTARY INFORMATION section) are information, or other information that incorrect may submit either electronic identifies you in the body of your Leslie Kux, or written comments and ask for a comments, that information will be Associate Commissioner for Policy. redetermination by January 30, 2017. posted on http://www.regulations.gov. [FR Doc. 2016–28732 Filed 11–28–16; 8:45 am] Furthermore, any interested person may • If you want to submit a comment BILLING CODE 4164–01–P petition FDA for a determination with confidential information that you regarding whether the applicant for do not wish to be made available to the extension acted with due diligence public, submit the comment as a DEPARTMENT OF HEALTH AND written/paper submission and in the HUMAN SERVICES during the regulatory review period by May 30, 2017. See ‘‘Petitions’’ in the manner detailed (see ‘‘Written/Paper SUPPLEMENTARY INFORMATION section for Submissions’’ and ‘‘Instructions’’). Food and Drug Administration more information. Written/Paper Submissions [Docket No. FDA–2016–E–0622] ADDRESSES: You may submit comments Submit written/paper submissions as as follows: follows: Determination of Regulatory Review Period for Purposes of Patent Electronic Submissions • Mail/Hand delivery/Courier (for written/paper submissions): Division of asabaliauskas on DSK3SPTVN1PROD with NOTICES Extension; NUWIQ Submit electronic comments in the Dockets Management (HFA–305), Food AGENCY: Food and Drug Administration, following way: and Drug Administration, 5630 Fishers HHS. • Federal eRulemaking Portal: http:// Lane, Rm. 1061, Rockville, MD 20852. ACTION: Notice. www.regulations.gov. Follow the • For written/paper comments instructions for submitting comments. submitted to the Division of Dockets SUMMARY: The Food and Drug Comments submitted electronically, Management, FDA will post your Administration (FDA) has determined including attachments, to http:// comment, as well as any attachments, the regulatory review period for NUWIQ www.regulations.gov will be posted to except for information submitted, VerDate Sep<11>2014 17:48 Nov 28, 2016 Jkt 241001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\29NON1.SGM 29NON1

Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices 85975 marked and identified, as confidential, Rm. 6250, Silver Spring, MD 20993, review period and that the approval of if submitted as detailed in 301–796–3600. NUWIQ represented the first permitted ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION: commercial marketing or use of the Instructions: All submissions received product. Thereafter, the USPTO I. Background requested that FDA determine the must include the Docket No. FDA– 2016–E–0622 for ‘‘Determination of The Drug Price Competition and product’s regulatory review period. Regulatory Review Period for Purposes Patent Term Restoration Act of 1984 II. Determination of Regulatory Review of Patent Extension; NUWIQ.’’ Received (Pub. L. 98–417) and the Generic Period comments will be placed in the docket Animal Drug and Patent Term Restoration Act (Pub. L. 100–670) FDA has determined that the and, except for those submitted as generally provide that a patent may be applicable regulatory review period for ‘‘Confidential Submissions,’’ publicly extended for a period of up to 5 years NUWIQ is 2,622 days. Of this time, viewable at http://www.regulations.gov so long as the patented item (human 2,165 days occurred during the testing or at the Division of Dockets drug product, animal drug product, phase of the regulatory review period, Management between 9 a.m. and 4 p.m., medical device, food additive, or color while 457 days occurred during the Monday through Friday. additive) was subject to regulatory approval phase. These periods of time • Confidential Submissions—To were derived from the following dates: submit a comment with confidential review by FDA before the item was marketed. Under these acts, a product’s 1. The date an exemption under information that you do not wish to be section 505(i) of the Federal Food, Drug, made publicly available, submit your regulatory review period forms the basis for determining the amount of extension and Cosmetic Act (21 U.S.C. 355(i)) comments only as a written/paper became effective: July 2, 2008. FDA has submission. You should submit two an applicant may receive. A regulatory review period consists of verified the applicant’s claim that the copies total. One copy will include the date the investigational new drug information you claim to be confidential two periods of time: A testing phase and an approval phase. For human application became effective was on with a heading or cover note that states July 2, 2008. ‘‘THIS DOCUMENT CONTAINS biological products, the testing phase begins when the exemption to permit 2. The date the application was CONFIDENTIAL INFORMATION.’’ The initially submitted with respect to the Agency will review this copy, including the clinical investigations of the biological becomes effective and runs human biological product under section the claimed confidential information, in 351 of the Public Health Service Act (42 its consideration of comments. The until the approval phase begins. The approval phase starts with the initial U.S.C. 262): June 5, 2014. FDA has second copy, which will have the verified the applicant’s claim that the claimed confidential information submission of an application to market the human biological product and biologics license application (BLA) for redacted/blacked out, will be available NUWIQ (BLA 125555/0) was initially for public viewing and posted on http:// continues until FDA grants permission to market the biological product. submitted on June 5, 2014. www.regulations.gov. Submit both 3. The date the application was copies to the Division of Dockets Although only a portion of a regulatory approved: September 4, 2015. FDA has Management. If you do not wish your review period may count toward the verified the applicant’s claim that BLA name and contact information to be actual amount of extension that the 125555/0 was approved on September 4, made publicly available, you can Director of USPTO may award (for 2015. provide this information on the cover example, half the testing phase must be This determination of the regulatory sheet and not in the body of your subtracted as well as any time that may review period establishes the maximum comments and you must identify this have occurred before the patent was potential length of a patent extension. information as ‘‘confidential.’’ Any issued), FDA’s determination of the However, the USPTO applies several information marked as ‘‘confidential’’ length of a regulatory review period for statutory limitations in its calculations will not be disclosed except in a human biological product will include of the actual period for patent extension. accordance with 21 CFR 10.20 and other all of the testing phase and approval In its application for patent extension, applicable disclosure law. For more phase as specified in 35 U.S.C. this applicant seeks 1,336 days of patent information about FDA’s posting of 156(g)(1)(B). term extension. FDA has approved for marketing the comments to public dockets, see 80 FR human biologic product NUWIQ III. Petitions 56469, September 18, 2015, or access (Antihemophilic Factor (Recombinant)). Anyone with knowledge that any of the information at: http://www.fda.gov/ NUWIQ is indicated for adults and the dates as published are incorrect may regulatoryinformation/dockets/ children with Hemophilia A for: submit either electronic or written default.htm. • On-demand treatment and control comments and ask for a redetermination Docket: For access to the docket to of bleeding episodes; (see DATES). Furthermore, any interested read background documents or the • perioperative management of person may petition FDA for a electronic and written/paper comments bleeding; determination regarding whether the received, go to http:// • routine prophylaxis to reduce the applicant for extension acted with due www.regulations.gov and insert the frequency of bleeding episodes. diligence during the regulatory review docket number, found in brackets in the Subsequent to this approval, the USPTO period. To meet its burden, the petition heading of this document, into the received a patent term restoration must be timely (see DATES) and contain asabaliauskas on DSK3SPTVN1PROD with NOTICES ‘‘Search’’ box and follow the prompts application for NUWIQ (U.S. Patent No. sufficient facts to merit an FDA and/or go to the Division of Dockets 7,572,619) from Octapharma AG, and investigation. (See H. Rept. 857, part 1, Management, 5630 Fishers Lane, Rm. the USPTO requested FDA’s assistance 98th Cong., 2d sess., pp. 41–42, 1984.) 1061, Rockville, MD 20852. in determining this patent’s eligibility Petitions should be in the format FOR FURTHER INFORMATION CONTACT: for patent term restoration. In a letter specified in 21 CFR 10.30. Beverly Friedman, Office of Regulatory dated April 20, 2016, FDA advised the Submit petitions electronically to Policy, Food and Drug Administration, USPTO that this human biological http://www.regulations.gov at Docket 10903 New Hampshire Ave., Bldg. 51, product had undergone a regulatory No. FDA–2013–S–0610. Submit written VerDate Sep<11>2014 17:48 Nov 28, 2016 Jkt 241001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\29NON1.SGM 29NON1

85976 Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices petitions (two copies are required) to the instructions for submitting comments. the claimed confidential information, in Division of Dockets Management (HFA– Comments submitted electronically, its consideration of comments. The 305), Food and Drug Administration, including attachments, to https:// second copy, which will have the 5630 Fishers Lane, Rm. 1061, Rockville, www.regulations.gov/ will be posted to claimed confidential information MD 20852. the docket unchanged. Because your redacted/blacked out, will be available Dated: November 22, 2016. comment will be made public, you are for public viewing and posted on solely responsible for ensuring that your https://www.regulations.gov/. Submit Leslie Kux, comment does not include any both copies to the Division of Dockets Associate Commissioner for Policy. confidential information that you or a Management. If you do not wish your [FR Doc. 2016–28654 Filed 11–28–16; 8:45 am] third party may not wish to be posted, name and contact information to be BILLING CODE 4164–01–P such as medical information, your or made publicly available, you can anyone else’s Social Security number, or provide this information on the cover confidential business information, such sheet and not in the body of your DEPARTMENT OF HEALTH AND as a manufacturing process. Please note comments and you must identify this HUMAN SERVICES that if you include your name, contact information as ‘‘confidential.’’ Any information, or other information that information marked as ‘‘confidential’’ Food and Drug Administration identifies you in the body of your will not be disclosed except in [Docket No. FDA–2013–D–0349] comments, that information will be accordance with 21 CFR 10.20 and other posted on https://www.regulations.gov/. applicable disclosure law. For more Providing Postmarketing Periodic • If you want to submit a comment information about FDA’s posting of Safety Reports in the International with confidential information that you comments to public dockets, see 80 FR Council for Harmonisation E2C(R2) do not wish to be made available to the 56469, September 18, 2015, or access Format (Periodic Benefit-Risk public, submit the comment as a the information at: http://www.fda.gov/ Evaluation Report); Guidance for written/paper submission and in the regulatoryinformation/dockets/ Industry; Availability manner detailed (see ‘‘Written/Paper default.htm. AGENCY: Food and Drug Administration, Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to HHS. Written/Paper Submissions read background documents or the ACTION: Notice of availability. Submit written/paper submissions as electronic and written/paper comments follows: received, go to https:// SUMMARY: The Food and Drug • Mail/Hand delivery/Courier (for www.regulations.gov/ and insert the Administration (FDA or Agency) is docket number, found in brackets in the written/paper submissions): Division of announcing the availability of a heading of this document, into the Dockets Management (HFA–305), Food guidance for industry entitled ‘‘Search’’ box and follow the prompts and Drug Administration, 5630 Fishers ‘‘Providing Postmarketing Periodic and/or go to the Division of Dockets Lane, Rm. 1061, Rockville, MD 20852. Safety Reports in the ICH E2C(R2) • For written/paper comments Management, 5630 Fishers Lane, Rm. Format (Periodic Benefit-Risk submitted to the Division of Dockets 1061, Rockville, MD 20852. Evaluation Report).’’ This guidance is Management, FDA will post your intended to inform applicants of the Submit written requests for single comment, as well as any attachments, copies of this guidance to the Division conditions under which FDA will except for information submitted, exercise its waiver authority to permit of Drug Information, Center for Drug marked and identified, as confidential, Evaluation and Research, Food and applicants to submit an International if submitted as detailed in Council for Harmonisation (ICH) Drug Administration, 10001 New ‘‘Instructions.’’ Hampshire Ave., Hillandale Building, (formerly International Conference on Instructions: All submissions received Harmonisation) E2C(R2) Periodic 4th Floor, Silver Spring, MD 20993– must include the Docket No. FDA– 0002; or the Office of Communication, Benefit-Risk Evaluation Report (PBRER) 2013–D–0349 for ‘‘Providing in place of the ICH E2C(R1) Periodic Outreach and Development, Center for Postmarketing Periodic Safety Reports Biologics Evaluation and Research Safety Update Report (PSUR), U.S. in the ICH E2C(R2) Format (Periodic Periodic adverse drug experience report Benefit-Risk Evaluation Report).’’ (CBER), Food and Drug Administration, (PADER), or U.S. Periodic adverse 10903 New Hampshire Ave., Bldg. 71, Received comments will be placed in Rm. 3128, Silver Spring, MD 20993– experience report (PAER), to satisfy the the docket and, except for those periodic safety reporting requirements 0002. Send one self-addressed adhesive submitted as ‘‘Confidential label to assist that office in processing in FDA regulations. The guidance Submissions,’’ publicly viewable at describes the steps applicants can take your requests. The guidance may also be https://www.regulations.gov/ or at the obtained by mail by calling CBER at 1– to submit the PBRER, and discusses the Division of Dockets Management format, content, submission deadline, 800–835–4709 or 240–402–8010. See between 9 a.m. and 4 p.m., Monday the SUPPLEMENTARY INFORMATION section and frequency of reporting for the through Friday. PBRER. for electronic access to the guidance • Confidential Submissions—To document. DATES: Submit either electronic or submit a comment with confidential written comments on the guidance at information that you do not wish to be FOR FURTHER INFORMATION CONTACT: Jean any time. made publicly available, submit your Chung, Center for Drug Evaluation and asabaliauskas on DSK3SPTVN1PROD with NOTICES ADDRESSES: You may submit comments comments only as a written/paper Research, Food and Drug as follows: submission. You should submit two Administration, 10903 New Hampshire copies total. One copy will include the Ave., Bldg. 22, Rm. 4466, Silver Spring, Electronic Submissions information you claim to be confidential MD 20993–0002, 301–796–2380; or Submit electronic comments in the with a heading or cover note that states Stephen Ripley, Center for Biologics following way: ‘‘THIS DOCUMENT CONTAINS Evaluation and Research, Food and • Federal eRulemaking Portal: https:// CONFIDENTIAL INFORMATION.’’ The Drug Administration,10903 New www.regulations.gov/. Follow the Agency will review this copy, including Hampshire Ave., Bldg. 71, Rm. 3128, VerDate Sep<11>2014 17:48 Nov 28, 2016 Jkt 241001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\29NON1.SGM 29NON1


Document Created: 2016-11-29 00:33:33
Document Modified: 2016-11-29 00:33:33
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 (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by January 30, 2017. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by May 30, 2017. 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 Citation81 FR 85974 
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