[Federal Register Volume 78, Number 160 (Monday, August 19, 2013)]
[Proposed Rules]
[Pages 50358-50359]
[FR Doc No: 2013-20087]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 112

[Docket No. FDA-2011-N-0921]
RIN 0910-AG35

Notice of Intent To Prepare an Environmental Impact Statement for
the Proposed Rule, Standards for Growing, Harvesting, Packing, and
Holding of Produce for Human Consumption

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of Intent.

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SUMMARY: Under the National Environmental Policy Act of 1969 (NEPA), as
implemented by the Council on Environmental Quality (CEQ) regulations,
the Food and Drug Administration (FDA) announces its intent to prepare
an Environmental Impact Statement (EIS) to evaluate the potential
environmental effects of the proposed rule, Standards for Growing,
Harvesting, Packing, and Holding of Produce for Human Consumption. By
this notice, FDA is announcing the beginning of the scoping process to
solicit public comments and identify issues to be analyzed in an EIS.
Information on the proposed rule may be accessed using the docket
number found in brackets in the heading of this document.

DATES: This notice initiates the public scoping process for the EIS
which will close on November 15, 2013. The Agency will consider
comments in response to this notice to determine the need for any
public scoping meetings prior to the preparation of the Draft EIS. In
order to be considered during the preparation of the Draft EIS, all
comments must be received prior to the close of the public scoping
period. All relevant and substantive comments submitted to Docket No.
FDA-2011-N-0921 in response to the proposed rule will be considered as
part of the scoping process. FDA will provide additional opportunities
for public participation upon publication of the Draft EIS.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0921 and/or Regulatory Information Number (RIN) 0910-AG35, by any of
the following methods.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2011-N-0921 and RIN 0910-AG35 for this rulemaking.
All comments received may be posted without change to http://www.regulations.gov, including any personal information provided.
    Docket: For access to the docket to read background documents or
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: Annette McCarthy, Center for Food
Safety and Applied Nutrition (HFS-205), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: To minimize the risk of serious adverse
health consequences or death from consumption of contaminated produce,
FDA has published the proposed rule, Standards for Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption (``the produce
safety rule'' or ``the proposed rule'') to establish science-based
minimum standards for the safe growing, harvesting, packing, and
holding of produce, meaning fruits and vegetables grown for human
consumption (78 FR 3504, January 16, 2013). FDA has proposed these
standards as part of our implementation of the FDA Food Safety
Modernization Act (FSMA). These standards would not apply to produce
that is rarely consumed raw, produce for personal or on-farm
consumption, or produce that is not a raw agricultural commodity. In
addition, produce that receives commercial processing that adequately
reduces the presence of microorganisms of public health significance
would be eligible for exemption from the requirements of this rule. The
proposed rule would set forth procedures, processes, and practices that
minimize the risk of serious adverse health consequences or death,
including those reasonably necessary to prevent the introduction of
known or reasonably foreseeable biological hazards into or onto produce
and to provide reasonable assurances that the produce is not
adulterated on account of such hazards. We expect that the proposed
rule, if finalized as proposed, would reduce foodborne illness
associated with the consumption of contaminated produce.
    For the proposed rule, the Agency relied on a categorical exclusion
from the need to prepare an Environmental Assessment or EIS under 21
CFR 25.30(j). Based on currently available information, including
comments received, and upon further analysis, FDA has determined that
the proposed action may significantly affect the quality of the human
environment (21 CFR 25.22(b)) and, therefore, an EIS is necessary for
the final rule. For example, switching from surface to ground water was
originally considered a cost- and time-prohibitive option that was
unlikely to occur to any significant extent given that monitoring data
available prior to the publication of the proposed rule showed that
Escherichia. coli exceedance of the proposed standard occurred during 5
percent of the monitoring period with 55 percent of the incidents being
no more than 2 days, as discussed in the categorical exclusion memo
(see Ref. 266 of the proposed rule). Public comment, subsequent to the
publication of the proposed rule, has indicated that in some regions
current irrigation practices use water that is unlikely to meet the
proposed microbial standards for much, if not all of the growing
season. Consequently, if such standards are finalized, ground water is
likely to be explored as a more viable alternative water source for
irrigation in these regions than previous information had indicated.
Given recently highlighted concerns of ground water depletion (Ref. 1),
FDA has determined that the use of ground water for irrigation, in
response to a microbial standard, may significantly affect the quality
of the human environment. Similarly, comments received caused FDA to
reevaluate the proposed requirements for biological soil amendments of
animal origin, which propose an increasingly stringent set of
application restrictions based on the likelihood of the soil amendment
harboring pathogens. These proposed requirements, if finalized, are
expected to result in changes in current use of treated and untreated
biological soil amendments of animal origin or potentially greater use
of synthetic fertilizers. Changes in the type or handling of soil
amendments may significantly affect the quality of the human
environment.
    The purpose of the public scoping process for the EIS is to
determine relevant issues that will influence the scope of the
environmental analysis, including potential alternatives, and the
extent to which those issues and impacts will be analyzed in the EIS.
The EIS will be prepared in accordance with section 102(2)(C) of NEPA
(Pub. L. 91-190), FDA's NEPA implementing regulations (21 CFR Part 25),
and the CEQ regulations for implementing NEPA (40 CFR Parts 1500-1508).
Federal, State, and local Agencies, along with tribes and other
stakeholders that may be interested in or affected by the produce
safety rule are invited to participate in the scoping process. Some
Federal Agencies may request or be requested by the FDA to participate
in the development of the environmental analysis as a cooperating
agency. FDA has previously sought comment on potential environmental
effects as part of the public comment period for the proposed rule,
including specific questions regarding agricultural water, biological
soil amendments of animal origin, and wildlife (78 FR 3504 at 3616,
3619-3620). FDA believes that these questions are still relevant to the
environmental analysis and will consider comments received. FDA
encourages additional comments, as part of this scoping process, on
what specific issues, alternatives, mitigation measures, or other
information FDA should include for further analysis in the EIS for the
produce safety rule.

References

    The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has
verified the Web site address, but FDA is not responsible for any
subsequent changes to the Web site after this document publishes in the
Federal Register.)

    1. U.S. Geological Survey. 2013. Groundwater Depletion in the
United States (1900-2008). Scientific Investigation Report 2013-
5079. Available at: http://pubs.usgs.gov/sir/2013/5079/SIR2013-5079.pdf. Accessed July 30, 2013.

    Dated: August 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20087 Filed 8-16-13; 8:45 am]
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[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)]
[Notices]
[Pages 21555-21556]
[FR Doc No: 2016-08337]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-2345]

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

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 ADEMPAS 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 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 June
13, 2016. 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 October 11, 2016.
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, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-E-2345 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; ADEMPAS.'' 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,<PHONE_NUMBER>.

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 drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human 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 a human
drug 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 drug product ADEMPAS
(riociguat). ADEMPAS is indicated for treatment of adults with
persistent/recurrent Chronic Thromboembolic

Pulmonary Hypertension (CTEPH) after surgical treatment or inoperable
CTEPH to improve exercise capacity and WHO functional class; and
treatment of pulmonary arterial hypertension to improve exercise
capacity, improve WHO functional class, and to delay clinical
worsening. Subsequent to this approval, the USPTO received a patent
term restoration application for ADEMPAS (U.S. Patent No. 7,173,037)
from Bayer Intellectual Property GmbH, and the USPTO requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated March 19, 2015, FDA advised the USPTO
that this human drug product had undergone a regulatory review period
and that the approval of ADEMPAS 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
ADEMPAS is 2,394 days. Of this time, 2,151 days occurred during the
testing phase of the regulatory review period, while 243 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 (the FD&C Act) (21 U.S.C. 355(i)) became
effective: March 22, 2007. FDA has verified the Bayer Intellectual
Property GmbH claim that March 22, 2007, is the date the
investigational new drug application (IND) became effective.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: February
8, 2013. FDA has verified the applicant's claim that the new drug
application (NDA) for ADEMPAS (NDA 204819) was initially submitted on
February 8, 2013.
    3. The date the application was approved: October 8, 2013. FDA has
verified the applicant's claim that NDA 204819 was approved on October
8, 2013.
    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 1,317 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 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: April 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08337 Filed 4-11-16; 8:45 am]
 BILLING CODE 4164-01-P