[Federal Register Volume 87, Number 122 (Monday, June 27, 2022)]
[Notices]
[Pages 38161-38163]
[FR Doc No: 2022-13606]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0235]

Clinical Pharmacology Considerations for the Development of
Oligonucleotide Therapeutics; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Clinical
Pharmacology Considerations for the Development of Oligonucleotide
Therapeutics.'' This draft guidance describes FDA's recommendations
regarding clinical pharmacology considerations during the development
of oligonucleotide therapeutics, including characterizing the potential
for QT interval prolongation, performing immunogenicity risk
assessment, characterizing the impact of hepatic and renal impairment,
and assessing the potential for drug-drug interactions. The intent of
this guidance is to assist industry in the conduct of these studies.

DATES: Submit either electronic or written comments on the draft
guidance by September 26, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

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 identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-D-0235 for ``Clinical Pharmacology Considerations for the
Development of Oligonucleotide Therapeutics.'' Received comments 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,<PHONE_NUMBER>.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Anuradha Ramamoorthy, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3118, Silver Spring, MD 20903,
[email protected],<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Clinical Pharmacology Considerations for the Development of
Oligonucleotide Therapeutics.'' Oligonucleotide therapeutics are an
emerging therapeutic modality with increasing numbers of drugs in
development. While antisense and siRNA oligonucleotide therapeutics
have been approved in recent years to treat rare diseases, many
oligonucleotide therapeutics are in development to treat common chronic
diseases. This guidance provides recommendations to assist industry in
the development of oligonucleotide therapeutics. Specifically, this
guidance represents FDA's recommendations for certain pharmacokinetic
and pharmacodynamic investigations including characterizing QT interval
prolongation potential, performing immunogenicity risk assessment,
characterizing the impact of hepatic and renal impairment, and
assessing the potential for drug-drug interactions during
oligonucleotide therapeutic development. This guidance provides
recommendations on when these assessments may be appropriate and what
types of assessments can help address these issues.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). This draft guidance,
when finalized, will represent the current thinking of FDA on
``Clinical Pharmacology Considerations for the Development of
Oligonucleotide Therapeutics.'' It does not establish any rights for
any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR 312 for investigational new drug applications
and 21 CFR part 314 for new drug applications and abbreviated new drug
applications have been approved under OMB control numbers 0910-0014 and
0910-0001. The collections of information for biologics license
applications have been approved under OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

    Dated: June 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13606 Filed 6-24-22; 8:45 am]
BILLING CODE 4164-01-P


Comment Info: =================

General Comment:Title: MARAD/USCG Letter to ASIG Subject: Data Gap Status and Continuation of
Timeline Suspension dated January 7, 2009
Subject: Supplemental Materials
# of pages: 25 pages


ECONOMIC ANALYSIS OF THE EXPANSION

OF THE CROP GROUPING PROGRAM

Prepared by:

BIOLOGICAL AND ECONOMIC ANALYSIS DIVISION

OFFICE OF PESTICIDE PROGRAMS

September 6, 2007

U.S. Environmental Protection Agency

1200 Pennsylvania Ave, NW

Washington, DC 20640

I	Summary

This is a burden-reducing regulation.  Crop grouping saves money by
permitting the results of pesticide exposure studies for one crop to be
applied to other, similar crops.  The regulation exploits this
opportunity for saving money by expanding certain crop groups to include
more crops.

The primary beneficiaries of this regulation are minor crop producers
and consumers.  Minor crop producers benefit because lower registration
costs encourage more products to be registered on minor crops, providing
additional tools for pest control.  Consumers benefit by having a larger
supply of imported and domestically produced specialty produce at
potentially lower costs.  Secondary beneficiaries are pesticide
registrants, who benefit because expanded markets for pesticide products
lead to increased sales.  The IR-4 Project and EPA, which are publicly
funded federal government entities, more efficiently use resources as a
result of the rule.  The EPA benefits from broader operational
efficiency gains, which result from fewer emergency pesticide use
requests from specialty crop growers, the ability to conduct risk
assessment based on crop grouping, greater ease of establishing import
tolerances, greater capacity to assess risks of pesticides used on crops
not grown in the US, further harmonization of crop classification and
nomenclature, harmonized commodity import and export standards, and
increased potential for resource sharing between EPA and other pesticide
regulatory agencies.  Revisions to the crop grouping program result in
no appreciable costs or negative impacts to consumers, specialty crop
producers, pesticide registrants, the environment, or human health.

The impacts of the rule are measured primarily on a qualitative basis.
The efficiency gains experienced by the IR-4 are quantified in terms of
the cost of registering new uses under the old crop grouping program
versus the new program.

II	Background to the Final Rule

EPA is revising its crop grouping rule contained in 40 CFR part 180.40
and 180.41.  In this revision, EPA is expanding the crop grouping
program to include several minor crops (both domestically produced and
imported) that are not currently included in crop groups and subgroups,
and establishing new crop groups.  This rule represents the first group
in a series of amendments and changes to the crop grouping program.  The
Agency anticipates that future proposals of revisions to the crop
grouping program will become routine expansions as additional
appropriate changes are identified.

Statutory Authority:  EPA derives its statutory authority to establish
tolerances for pesticide residues in agricultural commodities under
section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) (21
U.S.C. 346a). A tolerance is the maximum permissible residue level
established for pesticides in raw agricultural produce and processed
foods.  The crop grouping regulations currently in 40 CFR 180.40 and
180.41 enable EPA to establish tolerances for a group of crops based on
residue data for crops that are representative of the group. The crop
grouping concept leads to the establishment of maximum residue levels
that could occur on any crop within the group.

Tolerance Setting:  Under section 408 of the Federal Food, Drug and
Cosmetic Act, EPA is responsible for establishing tolerances for
pesticide chemical residues in agricultural commodities.  A tolerance is
the maximum permissible pesticide residue level established for
pesticides in raw agricultural produce and processed foods.  To
establish a tolerance a petition is submitted to the Agency, requesting
the tolerance and furnishing information on the chemical identity,
composition, use pattern, toxicity, and nature and magnitude of the
residue of the proposed use.  EPA uses these data to determine the
appropriate tolerance level.

Crop Groups:  EPA regulations enable the establishment of tolerances for
a group of crops based on residue data for designated crops that are
representative of the group, e.g., root and tuber vegetables crop group
and the representative crops carrot, potato, radish, and sugar beet.
Crops are grouped based on similarities in cultural production
practices, edible food portions and animal feed items, residue levels,
geographical locations, and pest problems.  Representative crops have
the highest residues or are the most economically important in the
group.  Crop grouping allows for the estimate of the maximum level of
residue that could occur on any crop within the group.  The minimum data
base required for a group tolerance consists of residue on all
representative commodities for a group.  Once the group tolerance is
established, the tolerance level generally applies to all agricultural
commodities in the group.

Crop groups, in their current state, were established by EPA in 1995
along with crop subgroups, which are smaller more closely related groups
of commodities within a crop group with similar growth characteristics
and residue potential.  Representative commodities are also established
for subgroups.  The old crop grouping program has 19 Crop Groups and 18
Crop Subgroups (See Markle, Baron, and Schneider, 1998, pages 332-336)
However, since the establishment of these crop groupings in 1995, the
U.S. population has become more diverse, and demand for certain ethnic
foods that are not in crop groups has increased.  Growers of specialty
crops, striving to meet these demands, have requested more sub-grouping
options to meet the needs of changing markets. There is also a growing
international need for harmonizing crop groupings as the benefits of
work sharing become more apparent.

Need for Federal Regulation:  Pesticides are important products that
play a significant role in many aspects of the economy.  They are used
by diverse economic sectors such as agriculture, industry, and
residential.  Pesticides reduce or eliminate undesirable weeds, insects,
animals, fungi, and bacteria and are used to preserve wood and regulate
plant growth.  All of these pesticide uses produce desirable outcomes
such as increased agricultural productivity and improved human health.
However, due to their nature, their use also implies some environmental
and health risks (U.S. EPA, 1999c).  These risks are often external to
the market.  For this reason, the use of pesticides in the U.S. is
regulated to insure that their use does not lead to unacceptable risks
to the environment, applicators, and consumers of treated commodities.
The purpose of the rule is to reduce the burden of these pesticide
regulations on specialty crop producers and consumers.

III	Profile of affected Parties

IR-4, pesticide registrants, EPA, and specialty crop producers and
consumers will be affected by the rule.  The following provides a
profile of these parties and describes their involvement in establishing
or reliance on pesticide tolerances for specialty crops.

Interregional Research Project #4:  The following provides information
on the IR-4 Project.  Information used in this section was provided
primarily by IR-4 (IR-4, 2006b and IR-4, 2006c).

The IR-4 Project’s mission is to provide safe and effective pest
management options for specialty crop growers.  Their focus has
historically been to facilitate the registration of conventional crop
protection chemicals on fruits, vegetables, herbs and nuts.   More
recently IR-4 has incorporated nursery, floral, forestry seedling,
Christmas trees, and turf grass crops into their conventional
crop-protection-chemical program, and have added a biopesticide program.

The IR-4 Project is needed because there are insufficient financial
incentives for the agrochemical industry to invest in registering their
products for low use specialty crops.  Additionally, there are potential
liability issues from crop injury in low acreage, high value crops that
may create larger unfavorable risk-reward relationships for registrants.
 The IR-4 Project develops the data to support these registrations.  In
doing so, the IR-4 Project helps to improve the international
competitiveness of US agriculture. As the agrochemical industry
continues to undergo worldwide consolidation, the resources devoted to
specialty crops and minor uses continue to diminish (EPA, 2004). This
makes the role of the IR-4 increasingly critical for maintaining
effective pest control options for specialty crop producers.

The IR-4 Project operates as a partnership between the land grant
university system and the USDA. The headquarters staff, including the
Executive Director, is located at Rutgers University.  The USDA
Agricultural Research Service management is located in Beltsville,
Maryland, and the four regional staffs (each with a Regional Director)
are located at Cornell University at Geneva, Michigan State University,
the University of California at Davis, and the University of Florida.
Integration of activities is generally supplied through the IR-4
headquarters.  Long-term policy, coordination and integration are
provided by the IR-4 Management Committee with input and oversight from
the Administrative Advisers.

The IR-4 research planning process involves input from its partners and
stakeholders.  Most proposals for IR-4 assistance are transmitted from
growers through federal and state research and extension scientists
involved in high value specialty crop pest management.  IR-4 also
receives proposals (called Project Clearance Requests) directly from
growers and organizations representing commodity producers.  To maximize
grower awareness of the program and their input, IR-4 personnel
regularly attend grower meetings and tours.  In some cases, state level
IR-4 meetings are held and growers attend and submit Project Clearance
Requests.  The only group prohibited from submitting requests are
representatives of pesticide registrants.  Potential projects are,
however, submitted to registrants to determine their willingness to
accept public data to register uses.  The registrant can require that
efficacy trials be conducted to add a pest to the label where a
tolerance is obtained through the crop grouping process, or when data is
limited on pests for new pesticides.  Efficacy trials may be requested
by the registrant to reduce liability concerns due to product failure.

Project proposals approved by registrants are then prioritized at the
annual IR-4 Food Use and Ornamentals Workshops.  These workshops are
important because IR-4 can only conduct research on 10-15% of the
proposed researchable projects each year.   These Workshops are open
forums each attended by up to 200 growers, commodity organization
representatives, and federal and state research/extension scientists. At
the workshops, every potential project is discussed in detail and its
importance is considered on the basis of such factors as the
availability and efficacy of alternatives, pest damage potential,
performance of the proposed chemical, and its compatibility with
integrated pest management programs.

The output of these meetings is a list of projects designated as having
A, B or C priority, or as being eliminated from the research project
list.   In order to better serve growers, IR-4 attempts to complete
projects classified as “A” within a 30 month time frame.  Before
setting this goal, most studies had taken 4-5 years to complete. The
current success rate of this program is 70%.  IR-4 also conducts
research on as many Priority B projects as possible.  However, due to
resource limitations, currently less than 25% of Priority B projects are
researched and none from the Priority C list of projects.

Following Workshops where priority lists are established, a National
Research Planning Meeting is held to assign field and laboratory sites
for each research project for the coming year. About 100 food use
residue projects (crop-chemical combinations) involving 700 field trials
are typically undertaken annually.

For approved projects, a research protocol is drafted which contains the
proposed pattern of use, the number and location of field trials and
instructions for the analysis of the chemical and metabolites in the
commodity as specified by EPA.   EPA requires that this research be
conducted and documented following procedures outlined in the Good
Laboratory Practices guidelines.

IR-4 has 31 field research centers throughout the United States. They
also have a network of four regional, three ARS and two satellite
laboratories where analytical laboratory work is conducted to determine
crop residue levels.  All data from IR-4 sponsored studies are
transferred from the field sites or analytical laboratories to the IR-4
Headquarters where the data are placed into petition format required for
submission to EPA.  The data are also reviewed by the registrant.  Once
complete, the petition is submitted to EPA.

IR-4 also conducts an average of 600 efficacy trials for ornamentals
prioritized at the Ornamental Horticulture Workshop.  For non-food
crops, the research and registration process is much simpler and less
costly because field residue trials for supporting tolerances are not
required. Registrants can add ornamental crops and pests to their
registration once they are satisfied that the use is safe to the
ornamental plants and the chemical is effective against the target
pests.

Pesticide Registrants:  Pesticide registrants develop, produce,
formulate, package, distribute, and sell pesticide products.  Pesticide
products themselves fall into several categories: conventional
pesticides, biochemical pesticides, plant incorporated pesticides,
specialty and niche pesticides, and antimicrobial pesticides.
Conventional pesticides are those products that are commonly available
to users including herbicides (weed killers), insecticides (“bug”
killers), and fungicides (fungus killers), as well as some special
classifications such as fumigants used to sterilize soil to remove
pathogens.

Pesticide production involves combining substances into a formulation.
The most important ingredient of a pesticide product is the active
ingredient:  the chemical that is toxic to the targeted pest.  Some
pesticide formulations contain more than one active ingredient.  EPA
regulates both active ingredients and formulations through a
registration process.   There are roughly 890 active ingredients
registered with EPA, and nearly 18,000 registered products.

Manufacturers of pesticide active ingredients ship their products either
in raw form or as formulated product, with the majority being shipped to
distributors and dealers as formulated products.  A small amount of
active ingredient is shipped to independent formulators for further
preparation.  Distributors and dealers receive the product in a packaged
form ready for sale to end users.

While many economic sectors consume pesticide products, the agricultural
sector is by far the largest conventional pesticide user.  Pesticide
products support agricultural production of crops under varied weather
and pest pressure.  Pesticide products are more readily available for
crops grown on a large scale such as field corn and soybeans.

Specialty crops comprise nearly half of the value of agricultural
production in the U.S. (see below description of specialty crop
producers), yet there are often insufficient financial incentives for
pesticide registrants to invest in registering their products for
specific low acreage specialty crops.  There are also potential
liability issues from crop injury in low-acreage high-value crops that
may create unfavorable risk-reward relationships for registrants.  For
this reason, there can be hesitance on the part of pesticide registrants
to act to establish pesticide uses on specialty crops.

Potential IR-4 projects are submitted to registrants to determine their
activity or willingness to accept IR-4 data to establish new uses.
Thus, all IR-4 projects must first be cleared by registrants before
being reviewed and prioritized by IR-4.  If the registrants support the
projects they will submit necessary support data (such as environmental
and toxicological data) to the EPA and IR-4 will conduct the residue
trials and submit tolerance petitions.  Registrants will also be
involved in the IR-4 process by reviewing IR-4 study protocols,
providing test substances and analytical methods, drafting labels, and
reviewing IR-4 tolerance petitions.  Sometimes a registrant will support
IR-4 trials with some funding or will conduct analytical work.

U.S. EPA, Office of Pesticide Programs:  The EPA Office of Pesticide
Programs (OPP) is responsible for approving new pesticide uses and
processing tolerance petitions.  This process primarily involves EPA
scientists in the Office of Pesticide Programs conducting a
comprehensive review of the IR-4 residue and supporting registrant
toxicology data.   If the data show that the use would not expose
consumers or the environment to unreasonable adverse effects and there
exists a reasonable certainty that no harm will result to humans from
aggregate exposure to a pesticide from dietary and other sources, EPA
publishes a tolerance as a final rule in the Federal Register.  The
tolerance is the amount of the agricultural chemical in or on the crop
that is considered safe and legally acceptable.  The Agency’s process
of setting tolerances is as follows:

OPP receives a tolerance petition and residue chemistry data.  The
Agency screens the data to determine if it is in compliance with its
standards.

Once data passes the screen, OPP will issue a MRID tracking number for
each volume of data and make a copy of the data for OPP records.

With the MRID number assigned, OPP will begin the registration process.
Appropriate data are forwarded to the Health Effects Division (HED) and
the Environmental Fate and Effects Division (EFED) for review.

HED reviews residue chemistry data and conducts required human health
risk assessments.

EFED estimates anticipated exposure to drinking water that will result
from the proposed use and provides HED with these estimates for use in
the HED aggregate risk assessment.

Once the aggregate risk assessment is complete, if it is determined that
risk resulting from the pesticide is acceptable, the Agency drafts a
Federal Register Notice to establish tolerances.

Once drafted, HED and the Office of General Council (OGC) review the
document.  Changes are made based on HED and OGC reviews, which may
involve additional refinement of the risk assessment conducted by HED.

The Agency uploads supporting documentation to the public docket for
public viewing on the Internet.  A Federal Register Notice is then sent
for typesetting, signature, and publication.

OPP time required for tolerance petition review and establishment of new
tolerances will vary.  Typically review times for residue chemistry data
depend upon the use under consideration.  Whether the crop is grown in
one region or throughout the United States will determine how many field
trials will need to be conducted and the extent of the data.  EPA’s
residue chemistry guidelines provide this information on a per crop
basis.

Assessment of crop groups compared to a single crop may take longer
since the reviewer would have to input each commodity into the model.
However, the difference would be a matter of hours, not days (Madden,
2006). Therefore, besides the small time difference in reviewing residue
chemistry data, there is little difference in the time required to
conduct risk assessment of a single crop versus a crop group.
Additionally, if a crop group contains more representative crops, it
will require additional time when compared to a crop group with fewer
representative crops.

Upon EPA approval of the petition, the pesticide product’s new use
site and specific directions for use must be added to the label by the
registrant.  The product may be made available for national use, or be
confined to a limited geographical region.

Specialty Crop Producers:  Specialty crops, also called minor use crops,
are generally defined in the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) as any crop grown on 300,000 acres or less (EPA,
1997, page 15).  The USDA uses a broader classification which includes
most vegetables, fruit, nuts, herbs, spices, nursery, landscape plants,
greenhouse and flowers. Almost all food crops are minor use crops except
for the large acreage crops like corn, soybeans, wheat, oats, rice and
cotton.   According to USDA’s 2002 Census of Agriculture, specialty
crops account for over $43 billion dollars in annual sales, which is
about forty-six percent of the total agricultural sales for the US
(USDA, 2002).  Despite their large portion of agricultural sales,
specialty crops account for only about 3% of U.S. harvested cropland.

According to USDA, about three-fourths of specialty crop growers are
considered specialized, meaning that they receive at least half of their
farm revenue from production of fruits, vegetables, tree nuts, and
horticultural crops.  Specialized farms account for 95% of the total
value of U.S. specialty crop production, although more than half of them
have annual sales of less than $250,000 and non-farm income as their
primary means of support (USDA, 2006).

Consumers:  Consumers refers to the U.S. population.  Specialty crops
are a significant portion of the U.S. diet.  USDA estimates that
domestic consumption of fruit and vegetables accounted for about 17
percent of all at-home food expenditures in 2004. During the same
period, Americans spent an average of $224 per person ($561 per average
household) on fresh and processed fruit and vegetables consumed at home.
Many specialty crops consumed in the U.S. are imported.

The USDA estimates that per capita domestic consumption of fruits and
vegetables has risen over the past 20 years.  There has also been an
increase in consumer demand for fresh fruits and vegetables over this
same time period.  USDA explains these changes in U.S. consumption
patterns by noting that, “a population increasingly characterized by
households with fewer children and more adults in the workforce has been
supplemented by a surge in immigration from Latin America and Asia.
Shifts in consumer eating habits resulting from population changes have
influenced wholesale changes in the types of attributes consumers seek
with regard to fruit and vegetables” (USDA, 2006, page 12).
Consumption of specialty crops is expected to increase as the U.S.
population becomes increasingly diverse.

IV	The Process of Expanding Crop Groups

The following describes how changes to the crop grouping program were
developed and evaluated.  Information describing this process was
provided primarily to the Agency by IR-4 (IR-4, 2006c).

The International Crop Grouping Consulting Committee (ICGCC), led by
USDA IR-4 and composed of over 180 crop, agrichemical and regulatory
experts representing over 30 countries, initiates and leads the process
of creating new or amending existing crop groups by accepting and
reviewing crop group proposals from stakeholders. The IR-4 forwards the
proposal for a particular crop group to the appropriate workgroup of the
ICGCC and requests that workgroup members review and validate crop
group, subgroup, definition and commodities (including adding or
deleting commodities), verify commodity names, provide commodity
information including cultural, nutritional, and medicinal information,
and provide Maximum Residue Level (MRL) information on specific
commodities. Growers and commodity experts provide valuable input on
commodities. International members provide specific information on the
commodities grown in their countries and regions.  The proposal is also
forwarded to the IR-4 EPA Crop Grouping Working Group.  Based on the
discussion and information provided by the workgroup and the IR-4 EPA
Crop Grouping Working Group members, monographs are created for each of
the new commodities, or updates of existing monographs are prepared
along with information tables for crop group comparison. The group also
makes MRL comparison with Codex and European Union (EU) crop
classifications, and world production data on the relevant commodities.

The information and data described above is analyzed and discussed with
ICGCC work group members (includes U.S., North American Free Trade
Agreement (NAFTA), CODEX, and EU) to provide input on crop information
on the commodities. Based on the input the ICGCC prepares commodity
monographs, divide subgroups and selects representative crops.  After
all input has been validated and incorporated in the draft petition, the
petition is submitted to EPA for consideration.  Changes to the crop
grouping program outlined in the rule were a portion of those changes
initiated at the USDA IR-4 Crop Grouping Symposium in Arlington, VA,
October 2002 (USDA, 2002b).

IV	Expansion of Crop Groupings

The following provides a summary of the revisions for the Bulb
Vegetables Group and the Berries Group, both of which are modified by
the rule.  A description of the Edible Fungi Group is also provided
below.  This is a new crop group initiated by the rule.  The below
changes and additions to the crop grouping program were developed using
the above described process.   A detailed description of the changes are
provided in the text of the rule.

Crop Group 3: Bulb Vegetable Group:  EPA adds two crop subgroups to crop
group 3: bulb vegetable group.  EPA changes the name of the
representative commodities for the crop group by designating onion, bulb
and onion, green as the representative commodity. The representative
commodities for the group are currently listed as onion, green and onion
dry bulb.  EPA expands the crop group from seven to twenty-five
commodities.

Crop Group 13: Berry and Small Fruit Group:  EPA changes the name of the
“crop group 13: berries group to “crop group 13: berry and small
fruit group.”  EPA adds six new subgroups to crop group 13.  EPA
revises the representative crops from crop group 13 from “any one
blackberry or any one raspberry; and blueberry’, to “any one
blackberry or any one raspberry; highbush blueberry; lowbush blueberry;
elderberry or mulberry; grape; fuzzy kiwifruit; and strawberry’.  EPA
revises the existing crop group commodities.  EPA expands the crop group
to forty-six commodities.  EPA revises the caneberry subgroup 13A
commodities and expands the bushberry subgroup 13B by adding 13
additional commodities for a total of nineteen.

New Crop Group 21: Edible Fungi Group:  EPA initiates a new crop group,
entitled edible fungi; as crop group 21 and includes in this crop group
20 commodities in 12 fungi families.  EPA defines the representative
commodities for the edible fungi group as: “white button mushrooms and
any one oyster mushroom or any one shiitake mushroom.”

V	Economic Analysis

Approach to the Economic Analysis:  The expansion of the Agency’s crop
grouping program will significantly reduce the burden of pesticide
regulation for obtaining pesticide uses for specialty crops.  The
components of the impact of the rule that are evaluated in this
assessment are the beneficial impacts on minor crop growers and
consumers.  Consideration is also given to the secondary benefits that
accrue to pesticide registrants, which arise from expanded markets for
their pesticide products.  Operational efficiency gains are experienced
by EPA and IR-4 and are described.  The impacts of the rule are measured
primarily on a qualitative basis, though IR-4 efficiency gains are
quantified in terms of the cost of registering new uses under the old
crop grouping program versus the new program.

The impacts of the rule are analyzed by comparing specialty crop
pesticide availability under the old crop grouping program to the
program in the rule.  The impacts of the changes are considered
individually for each of the effected entities.  The impacts of the
expansion of crop group 3, bulb vegetables, and the new edible fungi
crop group, group 21, are used to illustrate the potential impacts of
the rule.  Consideration is also given for full adoption of the crop
grouping program developed by the International Crop Grouping Consulting
Committee, initiated at USDA/IR-4 Crop Grouping Symposium.

Costs and Negative Impacts of the Rule:  The Agency anticipates that
revisions to the crop grouping program result in no appreciable costs or
negative impacts to consumers, specialty crop producers, pesticide
registrants, the environment, or human health.

While this rule increases the number of pesticides with tolerances for
minor crops, it does not necessarily increase the amount of pesticides
released into the environment and may result in the use of safer
pesticides.  This is because changes to the crop grouping program
broadens the choice of pesticides for specialty crop producers and makes
newer safer pesticides available.  It is also likely that growers have a
greater ability to use integrated pest management systems that could
reduce environmental damage resulting from the use of pesticides.

Revisions to the crop grouping program maintain EPA standards for
protecting human health.  Representative crops for groups and subgroups
are chosen on the basis that they have the highest residues in the
group.  For this reason, risk assessments conducted for crop groups are
as conservative and comprehensive as risk assessments conducted for
individual crops.

Impact of the Rule for IR-4:  The rule increases the efficiency of the
IR-4 program.  IR-4 establishes tolerances for more crops with the same
residue trials, administrative process, and laboratory effort.

Under the old crop grouping program, IR-4 establishes a tolerance for a
single chemical crop combination by conducting the number of residue
trials specified in EPA guidance.  For a single chemical use on a crop,
between 1 and 20 residue trials are required (see EPA, 1996, page 54 for
specific requirements).  The average number of residue trials required
for a typical IR-4 chemical crop combination registration is 3 (IR-4,
2006c).  The average cost per trial is $300,000 and the average cost of
a typical IR-4 registration is $900,000

To establish a crop group tolerance, IR-4 conducts the specified number
of field trials (between 9 and 60 residue trials are required, depending
on the crop group, see EPA, 1996, page 57).  Typically, when residue
trials are conducted as part of a crop group request, there is a 25%
reduction in the number of trials.  Thus, to establish a use on bulb
onion, 8 trials are required.  Since bulb onion is a representative crop
for crop group 3, only 6 bulb onion trials (along with 3 green onion
trials) are required if trials are being conducted as part of a request
to establish a crop group tolerance.  IR-4 must also expend laboratory
and administrative resources in processing data collected in Residue
trials and administering the program.  IR-4 strives to establish crop or
crop group tolerances in a 30 month timeframe and accomplishes this for
70% of its research.

Changes to the crop grouping program in the rule increase the number of
crops covered by crop group tolerances.  Though the number of additional
covered crops varies by crop group, efficiency gains from the rule are
extensive.  They include the benefit of tolerances that are established
without the burden of the cost of residue trials, the 30 month
administrative process, and use of laboratory and analytical resources.
These efficiency gains are described in more detail in the sections that
consider the bulb vegetable crop group and new edible fungi crop group.

Impact of the Rule for EPA:  The EPA more efficiently uses the resources
it devotes to review tolerance petitions for specialty crop
registrations.  This includes personnel and resources used to guide
tolerance petitions through the registration process, and scientific
review process.  Under the new crop grouping program, the Agency
utilizes a similar level of resources to review tolerance petitions, but
can establish a greater number of tolerances for specialty crops.

Broader operational efficiency gains are also likely to accrue to the
Agency.  It is anticipated that crop grouping changes in the rule
facilitate risk assessments based on crop grouping, increase the ease of
establishing import tolerances, facilitate the risk assessment of
pesticides used on crops not grown in the US, promote harmonization in
crop classification and nomenclature, harmonize commodity import and
export standards, increase the potential for resource sharing between
EPA and other pesticide regulatory agencies, and reduce the need to
process emergency pesticide use requests on specialty crops under
Section 18 of FIFRA.

Benefits of the Rule for Specialty Crop Producers:  Changes to the crop
grouping program provide new safer pesticides to agricultural producers.
 The greater availability of pesticides to specialty crop producers
enhance IPM programs, decrease the probability of pest resistance by
providing more pest control tools, give more pesticide choices for
related crops grown in close proximity, and reduce the chance of
inadvertent residues on crops grown in close proximity, e.g., mustard
greens and kale.

Benefits of the Rule for Consumers:  The changes to the crop grouping
program lead to a more reliable and abundant supply of specialty
produce, including imports.  The rule promotes a safe food supply
through better pest control.  The rule promotes diversity in produce
available in the U.S.

Benefits of the Rule for Pesticide Registrants:  The primary benefits to
pesticide registrants of the changes to the crop grouping program are
additional sales of their pesticide products.  This occurs because of
wider availability of registered pesticides due to expanded and new crop
groups.  Pesticide registrants are required to add crop sites to the
label.  This is a potential burden of the rule, but requires minimal
effort on the part of the registrant and can be done at their choosing.

Companies may require or perform efficacy tests on all the crops in a
group or subgroup before they include them on pesticide labels.  This
may be needed if there are concerns about efficacy or phytotoxicity of
the pesticide on a given use site. Efficacy trials cost approximately
$4,200 and take one growing season to complete (Hong, 2006).  Crop
groups can be created that exclude certain crops, which may allow
registrants to minimize their efficacy data needs and target specific
crops.

Impacts of Changes to the Bulb Vegetable Crop Group:  The rule expands
crop group 3, bulb vegetables, from 7 to 26 crops. Under the old and new
crop grouping program, a crop group 3 tolerance can be established with
9 residue trials.   The rule creates 2 subgroups.  Subgroup 3-A, bulb
onion subgroup, is comprised of 10 crops with bulb onion as the
representative crop.  Six residue trials are required to establish a
subgroup tolerance.  Subgroup 3-B, green onion subgroup, is comprised of
17 crops with green onion as the representative crop.  Three residue
trials are required to establish a subgroup tolerance (Schneider, 2005).

The new crop group 3 tolerance covers 26 commodities, an increase of 19
from the old crop group.  The addition of these crops greatly increases
the efficiency of IR-4 and EPA in registering pesticides on specialty
crops.  Assuming that the crops added to the crop group require only 1
field trial to be granted a stand alone registration (grown on a
regional basis and on few enough acres), to accomplish the same result
without expanding crop group 3 would require 18 field trials, at a cost
of $5.4 million ($300,000 per field trial) and the administrative costs
of both the IR-4 testing process and the EPA review process.  In
addition, specialty crop producers potentially gain access to important
pest control tools on 18 bulb vegetable crops, consumers benefit from
the potential for a cheaper, more abundant, and varied supply of bulb
vegetables, and pesticide registrants potentially enjoy greater sales.

A similar calculation can be made for Subgroup 3A, bulb onion subgroup,
which consists of 10 crops and subgroup tolerance requirements of 6
trials.  In this case, 6 trials are required at $300,000 per trial, a
total of $1.8 million.  This is less than the 8 trials required for a
stand alone bulb onion tolerance.  Subgroup 3B, green onion, consists of
17 crops and a subgroup tolerance requires 3 trials.  This is the same
number of trials required for a stand alone green onion tolerance.

Impact of New Edible Fungi Crop Group:  The new crop group 21, edible
fungi, is comprised of 20 crops.  There are no subgroups in the new crop
group.  EPA has determined that the number of field trials needed for
this crop group is 3.  Two field trials are conducted with the white
button mushroom and one field trial is conducted with either the oyster
mushroom or the shiitake mushroom (Schneider, 2006).  Under the old
system, 3 residue trials are required for a stand alone tolerance on
mushroom.  Thus for 3 trials and a total residue trial cost of $900,000,
tolerances will be established for 20 mushroom crops, compared to a
single mushroom crop under the current crop grouping program.  The
equivalent cost of establishing these tolerances individually without
the benefit of the rule would be $18 million, in addition to cost of the
IR-4 and EPA administrative and scientific process.

Aggregate Economic Impacts:  Each year, the IR-4 establishes research
plans, based on proposed research projects, where projects are
designated as having A, B or C priority, or as being eliminated from the
research project list.   IR-4 can conduct research on 10-15% of the
proposed researchable projects each year.  For this reason, IR-4
carefully chooses which projects will be researched.  This is based on
such factors as the availability and efficacy of alternatives, pest
damage potential, performance of the proposed chemical, and its
compatibility with integrated pest management programs.  Under the old
crop grouping program, IR-4 conducted research on as many projects as
possible.  However, due to resource limitations, less than 25% of
Priority B projects were researched and none from the Priority C list of
projects.  Researched projects typically included about 100 food use
residue projects.  In 2005, IR-4 received approval of 136 permanent
tolerances leading to 659 uses, and 62 time-limited tolerances leading
to 293 uses (IR-4, 2006b and IR-4, 2006c).

Changes to the crop grouping program were initiated at the USDA/IR-4
Crop Grouping Symposium in Arlington, VA, October 2002.  Only a small
portion of these proposed changes are included in the rule.  Eventually,
however, it is the intention of the EPA and IR-4 crop grouping working
committee to expand the crop grouping program as is described in the
below table.

Current and Potential Crop Grouping Program

Categories	Current Crop Grouping	Future Crop Grouping Estimate

Commodities	508	1,000 – 1,500

Crop Groups	19	30 – 40

Subgroups	18	80

Ornamentals	0	900

Ornamental Groups	0	12

Source: Chen, Schneider, Nig, and Richardson, 2005.

If the crop grouping program is expanded as described above, the
efficiency of IR-4 research efforts and EPA pesticide registration
efforts could increase by 2 to 3 times.  This corresponds to a
comparable annual increase in the availability of pesticides for
specialty crop producers.  Furthermore, given the increase in crop
groups from 18 to 80, IR-4 will have added flexibility in tailoring
research efforts to meet the most pressing needs of specialty crop
producers.

VI	Paperwork Burden Analysis

This action does not contain any new information collection requirements
that need approval by the Office of Management and Budget under the
provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.  The
rule reduces mandatory paperwork, due to the elimination of data
required by the agency for crops that are included in the expanded crop
grouping program.

VII	References

Chen, H., B. Schneider, Y. Nig, and L. Richardson, 2005, ICGCC Report,
IR-4/EPA Crop Grouping Working Group.

Chen, H., 2006, E-mail communication with Bernard Schneider, 30 August
2006.

EPA, 1996, Residue Chemistry Test Guidelines, OPPTS 860.1500 Crop Field
Trials, EPA Publication 712–C–96–183,
http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/860_Residue_Ch
emistry_Test_Guidelines/Series/860-1500.pdf.

EPA, 1997, The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) and Federal Food, Drug, and Cosmetic Act (FFDCA) As Amended by
the Food Quality Protection Act (FQPA) of August 3, 1996, U.S.
Environmental Protection Agency, Office of Pesticide Programs.

EPA, 2004, Pesticide Industry Profile, Prepared by John Faulkner for
revision of Part 158W.

IR-4, 2006, 2005 IR-4 Annual Report, Report of the IR-4 Project
(NRSP-4/IR-4) January 1, 2005 - December 31, 2005,
http://ir4.rutgers.edu/Other/AnnualReports/2005AnnualReport.pdf.

IR-4, 2006b, 2005 Year in Review.
http://ir4.rutgers.edu/Other/YIR2005.pdf.

IR-4, 2006c, Information exchanged during meeting at EPA offices,
Arlington VA and by follow-up e-mail communication with J. Baron, 30
March 2006.

Madden, B., 2006, E-mail communication with Rame Cromwell, 5 September
2006.

Markle, G.M., J.J. Baron, and B.A. Schneider, 1998, Food and Feed Crops
of the United States, Second Edition, Revised, A Descriptive List
Classified According to Potentials for Potentials for Pesticide
Residues, a Regulatory Food Safety Focus, Meister Publishing Company.

Schneider, B., 2005, Crop Grouping – Part I:  Analysis of the USDA
IR-4 Petition to Amend the Crop Group Regulation 40 CFR ' 180.41 (c) (3)
and Commodity Definitions [40 CFR ' 180.1 (h)] Related to Crop Group 3
Bulb Vegetables, U.S. Environmental Protection Agency.

Schneider, B., 2006, ChemSAC Review of the USDA IR-4 Crop Grouping
Proposal to Establish a New Crop Group – Edible Fungi Group 21, U.S.
Environmental Protection Agency.

USDA, 2002, 2002 Census of Agricultural, U.S. Department of Agriculture,
http://www.nass.usda.gov/Census_of_Agriculture/.

USDA, 2002b, Report of the USDA/IR-4 Crop Grouping Symposium in
Arlington, VA, October 2002

USDA, 2006, Fruit and Vegetable Backgrounder, U.S Department of
Agriculture, Economic Research Service,   HYPERLINK
"http://www.ers.usda.gov/publications/VGS/apr06/vgs31301/vgs31301.pdf"
http://www.ers.usda.gov/publications/VGS/apr06/vgs31301/vgs31301.pdf

 The FIFRA definition of a minor use crop is, “… the use of a
pesticide on an animal, on a commercial agricultural crop or site, or
for the protection of public health where—

 (1)	the total United States acreage for the crop is less than 300,000
acres, as determined by the Secretary of Agriculture; or

 (2)	the Administrator, in consultation with the Secretary of
Agriculture, determines that, based on information provided by an
applicant for registration or a registrant, the use does not provide
sufficient economic incentive to support the initial registration or
continuing registration of a pesticide for such use and—

 (A)	there are insufficient efficacious alternative registered
pesticides available for the use;

 (B)	the alternatives to the pesticide use pose greater risks to the
environment or human health;

 (C)	the minor use pesticide plays or will play a significant part in
managing pest resistance; or

 (D)	the minor use pesticide plays or will play a significant part in an
integrated pest management program.

The status as a minor use under this subsection shall continue as long
as the Administrator has not determined that, based on existing data,
such use may cause an unreasonable adverse effect on the environment and
the use otherwise qualifies for such status” (EPA, 1997, page 15).

 PAGE

 PAGE   15


[Federal Register Volume 81, Number 183 (Wednesday, September 21, 2016)]
[Notices]
[Pages 64904-64905]
[FR Doc No: 2016-22672]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9926-08-OEI]

Cross-Media Electronic Reporting: Authorized Program Revision
Approval, State of Alaska

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces EPA's approval of the State of Alaska's
request to revise/modify its EPA Administered Permit Programs: The
National Pollutant Discharge Elimination System EPA-authorized program
to allow electronic reporting.

DATES: EPA's approval is effective September 21, 2016.

FOR FURTHER INFORMATION CONTACT: Karen Seeh, U.S. Environmental
Protection Agency, Office of Environmental Information, Mail Stop
2823T, 1200 Pennsylvania Avenue NW., Washington, DC 20460, (202) 566-
1175<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On October 13, 2005, the final Cross-Media
Electronic Reporting Rule (CROMERR) was published in the Federal
Register (70 FR 59848) and codified as part 3 of title 40 of the CFR.
CROMERR establishes electronic reporting as an acceptable regulatory
alternative to paper reporting and establishes requirements to assure
that electronic documents are as legally dependable as their paper
counterparts. Subpart D of CROMERR requires that state, tribal or local
government agencies that receive, or wish to begin receiving,
electronic reports under their EPA-authorized programs must apply to
EPA for a revision or modification of those programs and obtain EPA
approval. Subpart D provides standards for such approvals based on
consideration of the electronic document receiving systems that the
state, tribe, or local government will use to implement the electronic
reporting. Additionally, Sec.  3.1000(b) through (e) of 40 CFR part 3,
subpart D provides special procedures for program revisions and
modifications to allow electronic reporting, to be used at the option
of the state, tribe or local government in place of procedures
available under existing program-specific authorization regulations. An
application submitted under the subpart D procedures must show that the
state, tribe or local government has sufficient legal authority to
implement the electronic reporting components of the programs covered
by the application and will use electronic document

receiving systems that meet the applicable subpart D requirements.
    On August 8, 2016, the Alaska Department of Environmental
Conservation (ADEC) submitted an application titled ``National
Pollutant Discharge Elimination System'' for revision/modification to
its EPA-approved program under title 40 CFR to allow new electronic
reporting. EPA reviewed ADEC's request to revise/modify its EPA-
authorized Part 123--EPA Administered Permit Programs: The National
Pollutant Discharge Elimination System program and, based on this
review, EPA determined that the application met the standards for
approval of authorized program revision/modification set out in 40 CFR
part 3, subpart D. In accordance with 40 CFR 3.1000(d), this notice of
EPA's decision to approve Alaska's request to revise/modify its Part
123--EPA Administered Permit Programs: The National Pollutant Discharge
Elimination System program to allow electronic reporting under 40 CFR
part 122 is being published in the Federal Register.
    ADEC was notified of EPA's determination to approve its application
with respect to the authorized program listed above.

Matthew Leopard,
Director, Office of Information Collection.
[FR Doc. 2016-22672 Filed 9-20-16; 8:45 am]
 BILLING CODE 6560-50-P


ASIWPCA Animal Ag Task Force Discussion of CAFO Rule Date Extension

June 6, 2007

Purpose:  To provide an opportunity for the States to ask questions
regarding the CAFO date extension proposed rule

Attendees:	Allison Wiedeman (EPA-OWM), Julie Javier (EPA-OWM), Sean
Rolland (ASIWPCA), Carol Galloway (EPA-OECA), Representatives from MI
Ag, MI, IN, CO, SC, MN, WA, WA Ag, OH, OH Ag, SD, DE, NC, IL, LA, NY,
ND, FL, VA, R7, EPA Ag Center

Summary:

Key issues/questions that came up during the meeting

What is delaying the issuance of the final rule? – EPA is working hard
in getting the rule revisions out as expeditiously as possible.
However, there are complex issues that precluded EPA from completing the
rule by July 31, 2007.  One of the key issues that EPA is wrestling with
is the determination of what terms of the NMP go into the permit.  The
proposed new deadline of February 27, 2009 will allow enough time for
the States and industry to prepare for the new regulations.  EPA intends
to promulgate the final rule well in advance of the February 2009 date.

Who needs to apply? Who are the newly defined CAFOs? – Some States
raised the issue that some existing CAFOs are ‘in limbo’ waiting for
the revised rule to be issued before applying for a permit.  EPA
referred to the Ben Grumbles memo to the Regions wherein it was stated
that “the proposed changes to the compliance dates would not supersede
existing state requirements.”  The States should be implementing their
regulations.  Also, the 25-yr 24-hr storm exemption was removed from the
2003 rule so that existing CAFOs who discharge even with the required
containment structure in place are required to obtain a permit.

Ag stormwater exemption discussion – EPA is considering comments
received on this issue and is in the process of determining how to
respond.

What is a discharge?  Who determines it? – EPA explained that with the
elimination of the ‘duty to apply’ provision after Waterkeeper, the
determination of the need to apply for a permit rests with the CAFO
operator.  However, permitting authorities can inspect nonpermitted
facilities to determine whether or not they are discharging without a
permit.  As presented in the last CAFO roundtable, OECA made CAFO
inspection and compliance one of their top priorities.

NMP implementation – The question was asked why the date for NMP
implementation is being extended if the NMP should be implemented
anyway.  EPA replied that the standards of the NMP did not change.
However, the process to incorporate the terms of the NMP into the permit
as well as what are enforceable NMP terms are new requirements resulting
from the Waterkeeper decision.  This is why the NMP date is being
extended as well.  EPA stressed the importance of States considering
some type of process to get CAFOs needing permits to develop their NMPs
now in order to prevent a log jam when the deadline comes.

Implementing programs without a federal regulation – There was general
angst expressed by the States regarding the lack of a federal rule in
the near future because States want support in implementing their
programs – especially those who have already, or are planning to,
revise their programs according to Waterkeeper.  EPA expressed its
intention to support State legislation while the final rule is being
developed and compile information that may assist them with program
revisions (see #7 below).

Is there a system/protocol to assist States in determining what a
discharge is? – EPA suggested a training session for States similar to
the Dallas inspection training provided by OECA in November 2006 for
Agency personnel.  It was further suggested that this can be on the
agenda for the next CAFO roundtable.  OECA and OWM are also working on
putting together materials for the regions that will help them execute
their current programs.  The States want consistency and are therefore
very interested in having similar material.

Other issues

On farm assessment grant – EPA provided general information on the
grant and asked ASIWPCA to distribute the information to the States.

What is EPA (OWM) currently doing, besides the 2003 CAFO rule revision
that would be of interest to the States and ASIWPCA? – EPA is working
with USDA/NRCS on implementation of the MMP software.  Another project
that is currently being planned is an NMP training geared towards small
farms.

Action Items / Commitments

EPA will be working with OECA to put together an informational
packet/document that will help the States in implementing their existing
regulatory programs.  EPA also expressed its willingness to give States
technical support and general assistance with the permitting process
while the final rule is being revised.

Adjourn

 PAGE

 PAGE   1


[Federal Register Volume 76, Number 221 (Wednesday, November 16, 2011)]
[Notices]
[Page 71005]
[FR Doc No: 2011-29548]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 1490-052]

Brazos River Authority; Notice of Application Accepted for
Filing, Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Surrender of License.
    b. Project No.: 1490-052.
    c. Date Filed: July 20, 2011, and supplemented October 28, 2011.
    d. Applicant: Brazos River Authority.
    e. Name of Project: Morris Sheppard Hydroelectric Project.
    f. Location: On the Brazos River, in Palo Pinto, Young and Stephens
Counties, Texas.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Mr. John A. Whittaker, IV, Winston & Strawn
LLP, 1700 K Street NW., Washington, DC 20006,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    i. FERC Contact: Mr. Jeremy Jessup,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests, is 30 days from the issuance date of this notice. All
documents may be filed electronically via the Internet. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
at http://www.ferc.gov/docs-filing/efiling.asp. If unable to be filed
electronically, documents may be paper-filed. To paper-file, an
original and seven copies should be mailed to: Secretary, Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426. Commenters can submit brief comments up to 6,000 characters,
without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and
contact information at the end of your comments.
    Please include the project number (P-1490-052) on any comments,
motions, or protests filed.
    k. Description of Request: The applicant proposes to surrender the
license and decommission the generating facilities for the Morris
Sheppard Project (P-1490). The applicant states that the project is not
economically feasible due to the repairs that would be necessary to
restore generation and continued expenses associated with administering
lands along the shoreline of the reservoir. The applicant proposes to
retain the existing dam and project reservoir, and install a control
outlet structure for continued use in water management and supply
operations.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number excluding the last three digits
in the docket number field to access the document. You may also
register online at http://www.ferc.gov/docs-filing/esubscription.asp to
be notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filing must (1)
Bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE'' as applicable; (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis and otherwise comply with the requirements of 18 CFR
4.34(b). All comments, motions to intervene, or protests should relate
to project works which are the subject of the license surrender.
Agencies may obtain copies of the application directly from the
applicant. A copy of any protest or motion to intervene must be served
upon each representative of the applicant specified in the particular
application. If an intervener files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency. A copy of all other
filings in reference to this application must be accompanied by proof
of service on all persons listed in the service list prepared by the
Commission in this proceeding, in accordance with 18 CFR 4.34(b) and
385.2010.

    Dated: November 9, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-29548 Filed 11-15-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 113 (Monday, June 13, 2016)]
[Proposed Rules]
[Pages 38113-38115]
[FR Doc No: 2016-13734]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 81, No. 113 / Monday, June 13, 2016 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-6898; Directorate Identifier 2016-NM-010-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
The Boeing Company Model MD-90-30 airplanes. This proposed AD was
prompted by reports of stick shaker activation at airspeeds that were
above the stall protection system's stick shaker schedule. This
proposed AD would require installing angle-of-attack (AOA) sensor
external case heaters and AOA sensors, changing wires, and doing a
functional test and applicable corrective actions. We are proposing
this AD to correct water intrusion and subsequent ice formation between
the AOA sensor vane and face plate, which could cause the vane to
become immobilized. If the vane becomes immobilized, the stall
protection system could become unreliable or non-functional, which
could result in loss of control of the airplane.

DATES: We must receive comments on this proposed AD by July 28, 2016.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Boeing
Commercial Airplanes, Attention: Data & Services Management, 3855
Lakewood Boulevard, MC D800-0019, Long Beach, CA 90846-0001; telephone
206-544-5000, extension 2; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. It is also available on the Internet by
searching for and locating Docket No. FAA-2016-6898.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
6898; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (phone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Eric Igama, Aerospace Engineer,
Systems and Equipment Branch, ANM-130L, FAA, Los Angeles Aircraft
Certification Office (ACO), 3960 Paramount Boulevard, Lakewood, CA
90712-4137; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2016-6898;
Directorate Identifier 2016-NM-010-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We received reports of stick shaker activation at airspeeds that
were above the stall protection system's stick shaker schedule. Stall
protection system anomalies have been reported on Model 717-200
airplanes related to the AOA sensor becoming immobilized and reporting
incorrect AOA alpha values. Boeing investigated and found potential
water intrusion and subsequent ice formation between the AOA sensor
vane and face plate could cause the vane to become immobilized until
the airplane is operated at temperatures above freezing. Model MD-90
airplanes use the same AOA sensors as the Model 717 airplanes and the
same potential for AOA vane immobilization exists. This condition, if
not corrected, could cause the vane to become immobilized. If the vane
becomes immobilized, the stall protection system could become
unreliable or non-functional, which could result in loss of control of
the airplane.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin MD90-30A029, dated
November 25, 2015. The service information describes procedures for
installing AOA sensor external case heaters and AOA sensors, changing
wires, and doing a functional test and applicable corrective actions.
This service information is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of these same type
designs.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in the service information described previously. For information on the
procedures, see this service information at http://www.regulations.gov
by searching for and locating Docket No. FAA-2016-6898.
    The phrase ``corrective actions'' is used in this proposed AD.
``Corrective actions'' are actions that correct or address any
condition found. Corrective actions in an AD could include, for
example, repairs.

Costs of Compliance

    We estimate that this proposed AD affects 95 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                   Labor cost          Parts cost       Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Installation of AOA sensor        Up to 44 work-      Up to $1,220        Up to $4,960        Up to $471,200
 external case heaters and AOA     hours (depending    (depending on the   (depending on the   (depending on the
 sensors, changing wires, and      on the group        group number).      group number).      group number).
 doing a functional test.          number) x $85 per
                                   hour = $3,740.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

The Boeing Company: Docket No. FAA-2016-6898; Directorate Identifier
2016-NM-010-AD.

(a) Comments Due Date

    We must receive comments by July 28, 2016.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all The Boeing Company Model MD-90-30
airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 34, Navigation.

(e) Unsafe Condition

    This AD was prompted by reports of stick shaker activation at
airspeeds that were above the stall protection system's stick shaker
schedule. We are issuing this AD to correct water intrusion and
subsequent ice formation between the angle-of-attack (AOA) sensor
vane and face plate, which could cause the vane to become
immobilized. If the vane becomes immobilized, the stall protection
system could become unreliable or non-functional, which could result
in loss of control of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Installation of AOA Sensor External Case Heater

    Within 6 years after the effective date of this AD, install AOA
sensor external case heaters and AOA sensors, change wires, and do a
functional test and applicable corrective actions, in accordance
with the Accomplishment Instructions of Boeing Alert Service
Bulletin MD90-30A029, dated November 25, 2015. All applicable
corrective actions must be done before further flight.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles Aircraft Certification Office
(ACO), FAA, has the authority to approve AMOCs for this AD, if
requested using the procedures found in 14 CFR 39.19. In accordance
with 14 CFR 39.19, send your request to your principal inspector or
local Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (i)(1) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Los Angeles ACO, to
make those findings. For a repair method to be approved, the repair
must meet the certification basis of the airplane, and the approval
must specifically refer to this AD.
    (4) For service information that contains steps that are labeled
as Required for Compliance (RC), the provisions of

paragraphs (h)(4)(i) and (h)(4)(ii) of this AD apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. An AMOC is required for any deviations to RC steps,
including substeps and identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(i) Related Information

    (1) For more information about this AD, contact Eric Igama,
Aerospace Engineer, Systems and Equipment Branch, ANM-130L, FAA, Los
Angeles ACO, 3960 Paramount Boulevard, Lakewood, CA 90712-4137;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
3855 Lakewood Boulevard, MC D800-0019, Long Beach, CA 90846-0001;
telephone<PHONE_NUMBER>, extension 2; fax<PHONE_NUMBER>; Internet
https://www.myboeingfleet.com. You may view this referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on June 3, 2016.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-13734 Filed 6-10-16; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 141 (Tuesday, July 23, 2019)]
[Notices]
[Pages 35399-35400]
From the Federal Register Online via the Government Publishing Office [http://www.gpo.gov/]
[FR Doc No: 2019-15595]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0424]

Final Guidance for Industry and FDA Staff on Postmarketing Safety
Reporting for Combination Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a final guidance for industry and FDA staff entitled
``Postmarketing Safety Reporting for Combination Products Guidance for
Industry and FDA Staff.'' The guidance describes and explains the final
rule on postmarketing safety reporting (PMSR) for combination products,
issued on December 20, 2016, and provides recommendations for complying
with the PMSR requirements as well as hypothetical scenarios that
illustrate how to comply with certain PMSR requirements.

DATES: The announcement of the guidance is published in the Federal
Register on July 23, 2019.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time 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 below (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 identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2008-N-0424 for ``Postmarketing Safety Reporting for Combination
Products Guidance for Industry and FDA Staff.'' 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 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 http://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.gpo.gov/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 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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)). Submit written requests for a single hard copy of the
guidance document entitled ``Postmarketing Safety Reporting for
Combination

Products Guidance for Industry and FDA Staff'' to the Office of
Combination Products, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg 32, Room 5129, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Melissa Burns or John Barlow Weiner,
Office of Combination Products, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, 301-
796-8930.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry and
FDA staff entitled ``Postmarketing Safety Reporting for Combination
Products Guidance for Industry and FDA Staff.'' The guidance provides
general information on combination products; how FDA regulates
combination products; a summary of the combination product PMSR final
rule (21 CFR part 4, subpart B); an overview of which entities are
subject to the final rule and what safety reporting requirements apply
to such entities; detailed discussion of specific combination product
PMSR report types; guidance on where, how, and when to submit PMSR
reports to FDA; and hypothetical scenarios that illustrate how to
comply with certain combination product PMSR requirements.
    FDA carefully considered the comments received on the draft
guidance, and revised the guidance as appropriate in response to the
comments. Combination PMSR information, including examples to
illustrate how to report combination production information in
electronic reporting systems, is also available on FDA's website at
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products. FDA
encourages combination product applicants to contact the lead Center
for their combination product and/or the Office of Combination Products
if they have questions on PMSR compliance.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on Postmarketing Safety Reporting for
Combination Products. It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations. This guidance is not subject to Executive Order 12866.

III. Electronic Access

    Persons with access to the internet may obtain the guidance
document at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/combination-products-guidance-documents.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 314.80(c) and (e), as well as for
21 CFR 314.81(b) are approved under OMB control numbers 0910-0001,
0910-0230, and 0910-0291. The information collection provisions for 21
CFR 600.80 and 600.81 are approved under OMB control number 0910-0308.
Those for 21 CFR 606.170 are approved under OMB control number 0910-
0116. Those for 21 CFR 606.171 are approved under OMB control number
0910-0458. The information collection provisions for 21 CFR 803.50,
803.53, and 803.56 are approved under OMB control numbers 0910-0291 and
0910-0437. The information collection provisions for 21 CFR 806.10 and
806.20 are approved under OMB control number 0910-0359. The information
collection provisions for 21 CFR 4.102, 4.103, and 4.105 are approved
under OMB control number 0910-0834.

    Dated: July 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15595 Filed 7-22-19; 8:45 am]
 BILLING CODE 4164-01-P