82 FR 19063 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 78 (April 25, 2017)

Page Range		19063-19064
FR Document		2017-08325

The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Federal Register, Volume 82 Issue 78 (Tuesday, April 25, 2017)

[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19063-19064]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-08325]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1393]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Patent Term 
Restoration, Due Diligence Petitions, Filing, Format, and Content of 
Petitions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

[[Page 19064]]

SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 25, 
2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0233. 
Also include the FDA docket number found in brackets in the heading of 
this document.

Patent Term Restoration, Due Diligence Petitions, Filing, Format, and 
Content of Petitions--21 CFR Part 60--OMB Control Number 0910-0233--
Extension

SUPPLEMENTARY INFORMATION: FDA's patent extension activities are 
conducted under the authority of the Drug Price Competition and Patent 
Term Restoration Act of 1984 (21 U.S.C. 355(j)) and the Generic Animal 
Drug and Patent Term Restoration Act of 1988 (35 U.S.C. 156). New human 
drug, animal drug, human biological, medical device, food additive, or 
color additive products regulated by FDA must undergo FDA safety, or 
safety and effectiveness review before marketing is permitted. Where 
the product is covered by a patent, part of the patent's term may be 
consumed during this review, which diminishes the value of the patent. 
In enacting the Drug Price Competition and Patent Term Restoration Act 
of 1984 and the Generic Animal Drug and Patent Term Restoration Act of 
1988, Congress sought to encourage development of new, safer, and more 
effective medical and food additive products. It did so by authorizing 
the U.S. Patent and Trademark Office (USPTO) to extend the patent term 
by a portion of the time during which FDA's safety and effectiveness 
review prevented marketing of the product. The length of the patent 
term extension is generally limited to a maximum of 5 years, and is 
calculated by USPTO based on a statutory formula.
    When a patent holder submits an application for patent term 
extension to USPTO, USPTO requests information from FDA, including the 
length of the regulatory review period for the patented product. If 
USPTO concludes that the product is eligible for patent term extension, 
FDA publishes a notice that describes the length of the regulatory 
review period and the dates used to calculate that period. Interested 
parties may request, under Sec.  60.24 (21 CFR 60.24), revision of the 
length of the regulatory review period, or may petition under Sec.  
60.30 (21 CFR 60.30) to reduce the regulatory review period by any time 
where marketing approval was not pursued with ``due diligence.''
    The statute defines due diligence as ``that degree of attention, 
continuous directed effort, and timeliness'' as may reasonably be 
expected from, and are ordinarily exercised by, a person during a 
regulatory review period. As provided in Sec.  60.30(c), a due 
diligence petition ``shall set forth sufficient facts, including dates 
if possible, to merit an investigation by FDA or whether the applicant 
acted with due diligence.'' Upon receipt of a due diligence petition, 
FDA reviews the petition and evaluates whether any change in the 
regulatory review period is necessary. If so, the corrected regulatory 
review period is published in the Federal Register. A due diligence 
petition not satisfied with FDA's decision regarding the petition may, 
under Sec.  60.40 (21 CFR 60.40), request an informal hearing for 
reconsideration of the due diligence determination. Petitioners are 
likely to include persons or organizations having knowledge that FDA's 
marketing permission for that product was not actively pursued 
throughout the regulatory review period. The information collection for 
which an extension of approval is being sought is the use of the 
statutorily created due diligence petition.
    Since 1992, 20 requests for revision of the regulatory review 
period have been submitted under Sec.  60.24(a). In years 2013, 2014, 
and 2015, a total of five requests were submitted under Sec.  60.24(a). 
During that same time period, there have been no requests under 
Sec. Sec.  60.30 and 60.40; however, for purposes of this information 
collection approval, we are estimating that we may receive one 
submission annually.
    In the Federal Register of November 1, 2016 (81 FR 75824), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received in response to the 
notice.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
60.24(a)........................               3            1.66               5             100             500
60.30...........................               1               1               1              50              50
60.40...........................               1               1               1              10              10
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             560
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: April 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08325 Filed 4-24-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices 19063

collections of information in 21 CFR Avenue, Bldg. 51, Rm. 6314, Silver III. Participating in the Public
606.100, 606.121, 606.122, Spring, MD 20993, 301–796–7578, Workshop
606.160(b)(ix), 606.170(b), 610.40, and Kayla.Garvin@fda.hhs.gov. Registration: To register for the public
630.40 have been approved under OMB SUPPLEMENTARY INFORMATION: workshop, please visit the following
control numbers 0910–0116 and 0910– Web site: https://www.eventbrite.com/e/
0795; the collections of information in I. Background
sentinel-training-at-food-and-drug-
21 CFR 606.171 have been approved The Sentinel Initiative began in 2008 administration-registration-
under OMB control number 0910–0458. as a multiyear effort to create a national 32503315291. Please provide required
In the Federal Register of November electronic system for monitoring the contact information for each attendee,
7, 2016 (81 FR 78170), we published a performance of FDA-regulated medical including name, title, affiliation, and
60-day notice requesting public products. The Sentinel Initiative is email.
comment on the proposed extension of FDA’s response to the Food and Drug Registration is free and based on
this collection of information. No Administration Amendments Act of space availability, with priority given to
comments were received in response to 2007 (FDAAA) requirement that FDA early registrants. Early registration is
the notice. work with public, academic, and private recommended because seating is
Dated: April 18, 2017. entities to develop a system to obtain limited; therefore, FDA may limit the
Anna K. Abram, information from existing electronic number of participants from each
Deputy Commissioner for Policy, Planning, health care data from multiple sources organization. If time and space permit,
Legislation, and Analysis. to assess the safety of FDA approved onsite registration on the day of the
[FR Doc. 2017–08306 Filed 4–24–17; 8:45 am] medical products. public workshop will be provided
BILLING CODE 4164–01–P The Sentinel System uses a beginning at 9 a.m.
distributed data approach in which Data If you need special accommodations
Partners maintain physical and due to a disability, please contact Kayla
DEPARTMENT OF HEALTH AND operational control over electronic Garvin no later than June 30, 2017.
HUMAN SERVICES health care data in their existing Streaming Webcast of the public
environments. The distributed approach workshop: This public workshop will
Food and Drug Administration is achieved by using a standardized data also be Webcast at: https://
[Docket No. FDA–2017–N–0001] structure referred to as the Sentinel collaboration.fda.gov/
Common Data Model. Data Partners sentineltraining2017/.
Sentinel Training at the Food and Drug transform their data locally in If you have never attended a Connect
Administration; Public Workshop accordance with the Common Data Pro event before, test your connection at
Model, which enables them to execute https://collaboration.fda.gov/common/
AGENCY: Food and Drug Administration, standardized computer programs that help/en/support/meeting_test.htm. To
HHS. run identically at each Data Partner site. get a quick overview of the Connect Pro
ACTION: Notice of public workshop. Data Partners are able to review the program, visit https://www.adobe.com/
SUMMARY: The Food and Drug results of the queries before sending go/connectpro_overview. FDA has
Administration (FDA, the Agency, or them back to the Sentinel Operations verified the Web site addresses in this
we) is announcing the following public Center. Queries are distributed and document, as of the date this document
workshop entitled ‘‘Sentinel Training at results are returned through a secure publishes in the Federal Register, but
FDA.’’ The purpose of the public portal to preserve privacy. Web sites are subject to change over
workshop is to provide training to II. Topics for Discussion at the Public time.
understand the kinds of questions that Workshop Transcripts: Please be advised that
can be asked using health care claims transcripts will not be available.
data generally and within the FDA This full-day seminar, targeting Dated: April 19, 2017.
Sentinel System specifically, allowing clinical researchers and others without
Leslie Kux,
an understanding of the capabilities of direct experience using health care
claims data, will provide an overview of Associate Commissioner for Policy.
the Sentinel System. [FR Doc. 2017–08302 Filed 4–24–17; 8:45 am]
data that are and are not available in the
DATES: The public workshop will be
Sentinel Distributed Database, the BILLING CODE 4164–01–P
held on July 10, 2017, from 10 a.m. to Sentinel Common Data Model, and a
4 p.m. description of the distributed tools
ADDRESSES: The public workshop will available to work with the data. This DEPARTMENT OF HEALTH AND
be held at FDA’s White Oak Campus, seminar will help those in attendance HUMAN SERVICES
10903 New Hampshire Ave., Bldg. 31, understand the kinds of questions that
Rm. 1503 (the Great Room), Silver Food and Drug Administration
can be asked using health care claims
Spring, MD 20993. Entrance for the data generally and within the Sentinel [Docket No. FDA–2013–N–1393]
public workshop participants (non-FDA System specifically. Attendees will
employees) is through Building 1 where leave with an understanding of the Agency Information Collection
routine security check procedures will capabilities of the Sentinel System. The Activities; Submission for Office of
be performed. For parking and security Sentinel System can help the public, Management and Budget Review;
asabaliauskas on DSK3SPTVN1PROD with NOTICES

information, please refer to https:// academia, and private entities better Comment Request; Patent Term
www.fda.gov/AboutFDA/ understand potential safety issues Restoration, Due Diligence Petitions,
WorkingatFDA/BuildingsandFacilities/ associated with FDA-approved medical Filing, Format, and Content of
WhiteOakCampusInformation/ products. Importantly, users can get Petitions
ucm241740.htm. responses to their questions in a matter AGENCY: Food and Drug Administration,
FOR FURTHER INFORMATION CONTACT: of weeks, as compared to months, or HHS.
Kayla Garvin, Food and Drug even longer using traditional
ACTION: Notice.
Administration, 10903 New Hampshire surveillance methods.

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19064 Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices

SUMMARY: The Food and Drug which diminishes the value of the ‘‘shall set forth sufficient facts,
Administration (FDA or we) is patent. In enacting the Drug Price including dates if possible, to merit an
announcing that a proposed collection Competition and Patent Term investigation by FDA or whether the
of information has been submitted to the Restoration Act of 1984 and the Generic applicant acted with due diligence.’’
Office of Management and Budget Animal Drug and Patent Term Upon receipt of a due diligence petition,
(OMB) for review and clearance under Restoration Act of 1988, Congress FDA reviews the petition and evaluates
the Paperwork Reduction Act of 1995. sought to encourage development of whether any change in the regulatory
DATES: Fax written comments on the new, safer, and more effective medical review period is necessary. If so, the
collection of information by May 25, and food additive products. It did so by corrected regulatory review period is
2017. authorizing the U.S. Patent and published in the Federal Register. A
ADDRESSES: To ensure that comments on Trademark Office (USPTO) to extend due diligence petition not satisfied with
the information collection are received, the patent term by a portion of the time FDA’s decision regarding the petition
OMB recommends that written during which FDA’s safety and may, under § 60.40 (21 CFR 60.40),
comments be faxed to the Office of effectiveness review prevented request an informal hearing for
Information and Regulatory Affairs, marketing of the product. The length of reconsideration of the due diligence
OMB, Attn: FDA Desk Officer, FAX: the patent term extension is generally determination. Petitioners are likely to
202–395–7285, or emailed to oira_ limited to a maximum of 5 years, and include persons or organizations having
submission@omb.eop.gov. All is calculated by USPTO based on a knowledge that FDA’s marketing
comments should be identified with the statutory formula. permission for that product was not
OMB control number 0910–0233. Also When a patent holder submits an actively pursued throughout the
include the FDA docket number found application for patent term extension to regulatory review period. The
in brackets in the heading of this USPTO, USPTO requests information information collection for which an
document. from FDA, including the length of the extension of approval is being sought is
regulatory review period for the the use of the statutorily created due
Patent Term Restoration, Due Diligence patented product. If USPTO concludes diligence petition.
Petitions, Filing, Format, and Content of that the product is eligible for patent Since 1992, 20 requests for revision of
Petitions—21 CFR Part 60—OMB term extension, FDA publishes a notice the regulatory review period have been
Control Number 0910–0233—Extension that describes the length of the submitted under § 60.24(a). In years
SUPPLEMENTARY INFORMATION: FDA’s regulatory review period and the dates 2013, 2014, and 2015, a total of five
patent extension activities are used to calculate that period. Interested requests were submitted under
conducted under the authority of the parties may request, under § 60.24 (21 § 60.24(a). During that same time period,
Drug Price Competition and Patent CFR 60.24), revision of the length of the there have been no requests under
Term Restoration Act of 1984 (21 U.S.C. regulatory review period, or may §§ 60.30 and 60.40; however, for
355(j)) and the Generic Animal Drug petition under § 60.30 (21 CFR 60.30) to purposes of this information collection
and Patent Term Restoration Act of 1988 reduce the regulatory review period by approval, we are estimating that we may
(35 U.S.C. 156). New human drug, any time where marketing approval was receive one submission annually.
animal drug, human biological, medical not pursued with ‘‘due diligence.’’ In the Federal Register of November
device, food additive, or color additive The statute defines due diligence as 1, 2016 (81 FR 75824), we published a
products regulated by FDA must ‘‘that degree of attention, continuous 60-day notice requesting public
undergo FDA safety, or safety and directed effort, and timeliness’’ as may comment on the proposed collection of
effectiveness review before marketing is reasonably be expected from, and are information. No comments were
permitted. Where the product is covered ordinarily exercised by, a person during received in response to the notice.
by a patent, part of the patent’s term a regulatory review period. As provided FDA estimates the burden of this
may be consumed during this review, in § 60.30(c), a due diligence petition collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response

60.24(a) ................................................................................ 3 1.66 5 100 500
60.30 .................................................................................... 1 1 1 50 50
60.40 .................................................................................... 1 1 1 10 10

Total .............................................................................. ........................ ........................ ........................ ........................ 560
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: April 19, 2017.
Anna K. Abram,
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–08325 Filed 4–24–17; 8:45 am]
BILLING CODE 4164–01–P

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Document Created: 2017-04-25 02:18:15
Document Modified: 2017-04-25 02:18:15

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by May 25, 2017.
FR Citation		82 FR 19063

82 FR 19063 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 78 (April 25, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration