[Federal Register Volume 83, Number 74 (Tuesday, April 17, 2018)]
[Notices]
[Page 16852]
[FR Doc No: 2018-07999]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER18-1310-000]

Wheelabrator Millbury Inc.; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Wheelabrator Millbury Inc.'s application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is May 1, 2018.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
[email protected], or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: April 11, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-07999 Filed 4-16-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 166 (Wednesday, August 27, 2014)]
[Notices]
[Page 51208]
[FR Doc No: 2014-20341]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72893; File No. SR-NYSE-2014-32]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Designation of a Longer Period for Commission Action on
Proposed Rule Change Amending Rule 13 To Make the Add Liquidity Only
Modifier Available for Additional Limit Orders and Make the Day Time-
In-Force Condition Available for Intermarket Sweep Orders

August 21, 2014.
    On June 27, 2014, New York Stock Exchange LLC filed with the
Securities and Exchange Commission (``Commission'') pursuant to Section
19(b)(1) \1\ of the Securities Exchange Act of 1934 (``Act'') \2\ and
Rule 19b-4 thereunder,\3\ a proposed rule change to amend NYSE Rule 13
to make the Add Liquidity Only modifier available for additional limit
orders and make the day time-in-force condition available for
Intermarket Sweep Orders. The proposed rule change was published for
comment in the Federal Register on July 11, 2014.\4\ The Commission
received no comments on the proposal.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
    \4\ See Securities Exchange Act Release No. 72548 (July 7,
2014), 79 FR 40183.
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    Section 19(b)(2) of the Act \5\ provides that, within 45 days of
the publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
Commission is extending this 45-day time period. The Commission finds
that it is appropriate to designate a longer period within which to
take action on the proposed rule change so that it has sufficient time
to consider the proposed rule change.
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    \5\ 15 U.S.C. 78s(b)(2).
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    Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\6\ designates October 9, 2014, as the date by which the Commission
should either approve or disapprove or institute proceedings to
determine whether to disapprove the proposed rule change (File Number
SR-NYSE-2014-32).
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    \6\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
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    \7\ 17 CFR 200.30-3(a)(31).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-20341 Filed 8-26-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: September 4, 2008 (Volume 73, Number 172)]
[Proposed Rules]
[Page 51605-51606]
[DOCID:fr04se08-12]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

Proposed Modification of the Chicago, IL, Class B Airspace Area;
Public Meetings

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Supplemental notice of meetings.

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SUMMARY: On July 30, 2008, a notice to conduct informal airspace
meetings for the Chicago Class B airspace project was published in the
Federal Register (73 FR 44311). Subsequent to publication, the FAA has
had to change the venue of meetings 1 and 3, being held on September
23, 2008, and September 25, 2008, respectively. The address for both of
these meetings has changed to Signature Flight Center Hangar, 1061 S.
Wolf Road, Wheeling, IL 60090. The second meeting time and place
remains as previously published.

DATES: The informal airspace meetings will be held on Tuesday,
September 23, 2008, from 2 p.m.-7 p.m., Wednesday, September 24, 2008,
from 10 a.m.-2 p.m., and Thursday, September 25, 2008, from 2 p.m.-7
p.m.

ADDRESSES: (1) The meeting on Tuesday, September 23, 2008, will be held
at the Signature Flight Center hangar, 1061 S. Wolf Road, Wheeling, IL
60090. (2) The meeting on Wednesday, September 24, 2008, will be held
at DuPage Flight Center, Chicago DuPage Airport, 2700 International
Drive, West Chicago, IL 60185. (3) The meeting on Thursday, September
25, 2008, will be held at the Signature Flight Center hanger, 1061 S.
Wolf Road, Wheeling, IL 60090.

FOR FURTHER INFORMATION CONTACT: Annette Davis, Support Specialist,
Operations Support Group, Air Traffic Organization Central Service
Area, 2601 Meacham Blvd, Fort Worth, TX 76137; Telephone (817) 222-
5729.

SUPPLEMENTARY INFORMATION:

Background

    On July 30, 2008, a notice of meetings was published in the Federal
Register notifying the public of informal airspace

meetings for the Chicago Class B airspace project (73 FR 44311).
Subsequent to publication, the FAA learned that 2 of the meetings would
have to be held at a different location. This action changes the venue
of meetings 1 and 3 to the new locations.

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p.389.

    Issued in Washington, DC, on August 27, 2008.
Edith V. Parish,
Manager, Airspace and Rules Group.
 [FR Doc. E8-20438 Filed 9-3-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: January 16, 2009 (Volume 74, Number 11)]
[Notices]
[Page 3092-3093]
[DOCID:fr16ja09-119]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2008-1057]

Notification of the Imposition of Conditions of Entry for Certain
Vessels Arriving to the United States; Venezuela

AGENCY: Coast Guard, DHS.

ACTION: Notice.

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SUMMARY: The Coast Guard announces that it will impose conditions of
entry on vessels arriving from the country of Venezuela.

DATES: The policy announced in this notice will become effective
January 23, 2009.

ADDRESSES: This notice will be available for inspection and copying at
the Docket Management Facility at the U.S. Department of
Transportation, Room W12-140 on the Ground Floor of the West Building,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call Mr. Michael Brown, International Port Security Evaluation
Division, Coast Guard, telephone<PHONE_NUMBER>. If you have questions on
viewing or submitting material to the docket, call Ms. Renee V. Wright,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background and Purpose

    Section 70110 of the Maritime Transportation Security Act of 2002
(Pub. L. 107-295, Nov. 25, 2002) (46 U.S.C. 70110) provides that the
Secretary of Homeland Security may impose conditions of entry on
vessels requesting entry into the United States arriving from ports
that are not maintaining effective anti-terrorism measures. The Coast
Guard has been delegated the authority by the Secretary to carry out
the provisions of this section. Previous notices have imposed or
removed conditions of entry on vessels arriving from certain countries
and those conditions of entry and the countries they pertain to remain
in effect unless modified by this notice.
    The Coast Guard has determined that ports in Venezuela are not
maintaining effective anti-terrorism measures. Accordingly, effective
January 23, 2009 the Coast Guard will impose the following conditions
of entry on vessels

that visited ports in Venezuela during their last five port calls.
Vessels must:
     Implement measures per the ship's security plan equivalent
to Security level 2 while in a port in the above country;
     Ensure that each access point to the ship is guarded and
that the guards have total visibility of the exterior (both landside
and waterside) of the vessel while the vessel is in ports in the above
country. Guards may be provided by the ship's crew, however, additional
crewmembers should be placed on the ship if necessary to ensure that
limits on maximum hours of work are not exceeded and/or minimum hours
of rest are met, or provided by outside security forces approved by the
ship's master and Company Security Officer;
     Attempt to execute a Declaration of Security while in a
port in the above country;
     Log all security actions in the ship's log;
     Report actions taken to the cognizant U.S. Coast Guard
Captain of the Port prior to arrival into U.S. waters; and
     Based on the findings of the Coast Guard boarding or
examination, vessels may be required to ensure that each access point
to the ship is guarded by armed private security guards and that they
have total visibility of the exterior (both landside and waterside) of
the vessel while in U.S. ports. The number and position of the guards
has to be acceptable to the cognizant Coast Guard Captain of the Port
prior to the vessel's arrival.

    Dated: January 9, 2009.
Rear Admiral Sally Brice-O'Hara,
USCG, Deputy Commandant for Operations.
 [FR Doc. E9-845 Filed 1-15-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 76, Number 140 (Thursday, July 21, 2011)]
[Notices]
[Page 43684]
[FR Doc No: 2011-18441]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER11-4041-000]

Verde Energy USA Trading, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Verde Energy USA Trading, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is August 3, 2011.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: July 15, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-18441 Filed 7-20-11; 8:45 am]
BILLING CODE 6717-01-P


60960 Federal Register / Vol. 67, No. 188 / Friday, September 27, 2002 / Rules and Regulations Commodity Parts per million Barley, grain ............................. 0.05 Barley, hay ................................ 0.05 Barley, straw ............................. 0.05 Wheat, forage ........................... 0.05 Wheat, grain ............................. 0.05 Wheat, hay ............................... 0.05 Wheat, straw ............................. 0.05 (b) Section 18 emergency exemptions. [Reserved] (c) Tolerances with regional registrations. [Reserved] (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 02– 24650 Filed 9– 26– 02; 8: 45 am]

BILLING CODE 6560– 50– S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [OPP– 2002– 0233; FRL– 7198– 8]

Pseudozyma flocculosa strain PF A22 UL; Exemption from the Requirement of a Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule.

SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of the Pseudozyma flocculosa strain PF A22 UL in or on all food commodities. Plant Products Co. Ltd., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996, requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Pseudozyma flocculosa strain PF A22 UL. DATES: This regulation is effective September 27, 2002. Objections and requests for hearings, identified by docket ID number OPP– 2002– 0233, must be received on or before November 26, 2002. ADDRESSES: Written objections and hearing requests may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit IX. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your objections and hearing requests must identify docket ID number OPP– 2002– 0233 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: Sharlene R. Matten, c/ o Product Manager (PM) 90, Biopesticides and Pollution Prevention Division (7511C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 605– 0514; e mail address: matten. sharlene@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

Categories NAICS codes Examples of potentially affected entities Industry 111 Crop production 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select `` Laws and Regulations, '' `` Regulations and Proposed Rules, '' and then look up the entry for this document under the `` Federal Register— Environmental Documents. '' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml _ 00/ Title 40/ 40cfr180 00. html, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http:// www. epa. gov/ opptsfrs/ home/ guidelin. htm. 2. In person. The Agency has established an official record for this action under docket ID number OPP– 2002– 0233. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305– 5805.

II. Background and Statutory Findings In the Federal Register of August 30, 2000 (65 FR 52749) (FRL– 6739– 8), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U. S. C. 346a( d), as amended by the Food Quality Protection Act (FQPA) (Public Law 104– 170), announcing the filing of a pesticide tolerance petition (PP 0F6136) by Plant Products Co. Ltd., f314 Orenda Rd., Brampton, Ontario, Canada L6T 1G1. This notice included a summary of the petition prepared by the petitioner Plant Products Co. Ltd. There were no comments received in response to the notice of filing. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Pseudozyma flocculosa strain PF A22 UL in or on all food commodities.

III. Risk Assessment New section 408( c)( 2)( A)( i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is `` safe. '' Section 408( c)( 2)( A)( ii) defines `` safe'' to mean that `` there is a reasonable certainty that no harm will result from aggregate exposure to the VerDate Sep< 04> 2002 16: 57 Sep 26, 2002 Jkt 197001 PO 00000 Frm 00108 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 27SER1. SGM 27SER1 60961 Federal Register / Vol. 67, No. 188 / Friday, September 27, 2002 / Rules and Regulations pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information. '' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408( b)( 2)( C) requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to `` ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .'' Additionally, section 408( b)( 2)( D) requires that the Agency consider `` available information'' concerning the cumulative effects of a particular pesticide's residues and `` other substances that have a common mechanism of toxicity. '' EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

IV. Toxicological Profile Consistent with section 408( b)( 2)( D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness, and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Pseudozyma flocculosa was isolated in 1986 from the leaves of red clover, Trifolium pratense, infected with powdery mildew, Erysiphe polygoni, by researchers at Agriculture and AgriFood Canada, Harrow, Ontario. Initially, this organism was erroneously identified as a new ascomycetous yeast with an anamorphic state in the broad genus Sporothrix and a teleomorphic state in the genus Stephanoascus. In 1995, its taxon was changed to P. flocculosa following ribosomal DNA analysis. The genus Pseudozyma contains other smut like anamorphs, including P. rugulosa (formerly Sporothrix rugulosa). P. flocculosa is a phyllosphere epiphyte and hyperparasite of primarily powdery mildew but has been isolated in association with other leaf surface molds. It is widely distributed in North America (Canada and USA) and in Europe on aerial plant surfaces in field or greenhouse agricultural ecosystems. P. flocculosa antagonizes a number of different powdery mildew fungi (Sphaerotheca pannosa var. rosae, Sphaerotheca fulginea, Erysiphe graminis var. tritici and Erysiphe polygoni) on many different plants in greenhouse and field environments when the relative humidity is greater or equal to 70%. This fungus is a necrotroph mycoparasite that kills susceptible target host cells upon contact or in close proximity. Rapid death and collapse of host cells without penetration is brought about by the secretion of three fungitoxic unsaturated C 17 fatty acids (9 heptadecenoic acid, 6 methyl 9 heptadecenoic acid and 4 methyl 7,11 heptadecadienoic acid) and an acyclic norterpene (2, 6, 10, 14, 18 pentamethyl 2, 6, 8, 10, 12, 14, 17 nonadecaheptene 1,19 diol). The fungitoxins disrupt susceptible plasma membranes and cytoplasmic organelles within 30 minutes of exposure. The inhibitory response includes a loss of proteins and electrolytes. After 24 hours, the host cells rapidly collapse and die as a result of the activity of the fungitoxins on the host cell's membranes and lipids. Sensitivity to the unsaturated C 17 free fatty acids is related to a high degree of unsaturation of phospholipid fatty acids and a low proportion of sterols. P. flocculosa strain PF A22 UL was considered of low toxicity and no pathogenicity based on the results of the Tier I toxicology studies. Tier II and Tier III studies were not required because the results from the Tier I studies were sufficient to satisfy guideline requirements. On the basis of the studies submitted, it was considered a Toxicity Category III pesticide for acute oral effects due to the amount dosed only, and Toxicity Category IV for dermal and primary dermal irritation health effects. These and additional toxicology studies are summarized below and in more detail in the Product Monograph for Pseudozyma flocculosa strain PF A22 UL which is found in the OPP docket number OPP– 2002– 0233. 1. Acute oral toxicity/ pathogenicity study (OPPTS 885.3050) (Master Record Identification (MRID) numbers 451152– 04 and 453634– 01). No signs of toxicity or pathogenicity were noted when Sporodex WP, a wettable powder formulation containing 2.0% (weight/ weight) P. flocculosa strain PF A22 UL was administered to rats via the oral route. In an acute oral toxicity study, groups of fasted 6 7 week old Fisher 344 rats (12/ sex) were administered a single oral dose of Sporodex WP in USP sterile water for injection at doses of 5.8 x 10 8 colony forming units (CFU) per animal for males and 5.6 x 10 8 CFU per animal for females. An equal number of animals were dosed with heat killed test substance and four animals/ sex served as untreated controls. The animals were then observed for a period of up to 21 days with interim scheduled sacrifices. No effect on body weight gain and no apparent signs of treatment related toxicity, infectivity or pathogenicity were observed in any of the treated animals during the study period. Clearance of the test organism occurred by, or prior to, post treatment day 7. Based on the results of this study, Sporodex L and its active ingredient, P. flocculosa, is not considered toxic or pathogenic to male or female Fisher 344 rats. 2. Acute pulmonary toxicity/ pathogenicity study (OPPTS 885.3150) (MRID numbers 451152– 06 and 453634– 01). The potential toxicity and pathogenicity of P. flocculosa was tested by observing the effects following a single intratracheal instillation of 3.2 x 10 7 CFU of the test organism (TS) to each of 12 male and 12 female CD rats. An equal number of animals were treated with heat killed test substance (KTS) and four animals/ sex served as untreated controls. Animals were observed for up to 14 days with interim scheduled sacrifices. A total of 15 rats (3/ 8 male and 2/ 8 female TS dosed rats and 6/ 8 male and 4/ 8 female KTS dosed rats) died on days 2 and 3. Laboured respiration, rough hair coat, ocular discharge and nasal discharge were observed in both TS and KTS dosed rats. Hunched posture and lethargy were also observed in one female and one male TS dosed rat, respectively. The presence or absence of clinical symptoms were not indicative of spontaneous deaths. Due to the large number of spontaneous deaths and a number of missed data collections, data for evaluating effects on body weights, food consumption and relative organ weight were limited. At the end of the 14– day long study, administration of P. flocculosa did not have a statistically significant effect on body weight. Analyses of daily food consumption and relative organ weights were skewed as they were either not determined or did not include animals that died prior to their scheduled sacrifice dates. At necropsy, liver lesions and lesions and enlargement of the lung and spleen were observed in both TS and KTSdosed rats. Confluent dark areas were also seen in the kidneys of a single male TS dosed rat. These necropsy findings were considered consistent with the VerDate Sep< 04> 2002 16: 57 Sep 26, 2002 Jkt 197001 PO 00000 Frm 00109 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 27SER1. SGM 27SER1 60962 Federal Register / Vol. 67, No. 188 / Friday, September 27, 2002 / Rules and Regulations method of dosing and the body's normal immunological response to a foreign substance. Pseudozyma flocculosa was detected in the lungs and lymph nodes and the stomach and small intestine of TS dosed animals only. Counts in these tissues were below the limit of detection by day 7. Based on this study, P. flocculosa is toxic, but not infective or pathogenic, at the dose administered when introduced by the intratracheal route to male and female CD rats. This acute pulmonary study, however, was originally classified as unacceptable due to major deficiencies in the collected data and a possible dosing error, as indicated by the presence of the microbial pest control agent (MPCA) in the stomach and small intestines on the day of dosing. However, there was relevant pathogenicity information that indicated clearance of the MPCA. Thus, this study is considered to be supplemental because it provides acceptable information regarding infectivity/ pathogenicity; however, this study does not differentiate the cause of certain mortalities in the TS and KTS treatments. A confirmatory acute pulmonary toxicity/ pathogenicity study using the technical grade of the active ingredient (TGAI) and testing of the sterile filtrate from the production culture will therefore be required to provide this additional information as a condition of registration. 3. Acute pulmonary range finding study (OPPTS 885.3150) (MRID numbers 451152– 07 and 453634– 01). In order to determine whether the test substance (in both its viable and non viable forms), P. flocculosa, was the cause of the deaths, a subsequent acute pulmonary rangefinding toxicity study was conducted. In this range finding study, groups of young adult CD rats (5/ sex/ dose level) were exposed by the intratracheal route to P. flocculosa (4.2 x 10 7 CFU/ mL) in ASTM Type 1 water at doses of 4.2 x 10 7 , 3.4 x 10 7 , 6.8 x 10 6 and 3.4 x 10 6 CFU/ animal. Animals were then observed for 14 days. There were no mortalities and all animals gained weight during the study. Rough hair coat occurred in a dose dependent manner with all 5 animals/ sex exhibiting this symptom at the highest dose of 4.2 x 10 7 CFU/ animal. One female dosed with 4.2 x 10 7 CFU experienced tremors, closed eyes and rough hair coat. Pseudozyma flocculosa was classified as being of slight toxicity (EPA Toxicity Category IV) based on adverse effects observed in some test animals. This acute pulmonary study was considered supplemental. According to USEPA OPPTS 885.3150, the minimum dose is 10 8 units of the MPCA per test animal. The maximum dose level used in this study, however, was only 4.2 x 10 7 CFU/ animal. Furthermore, infectivity was not addressed; however, the acute pulmonary toxicity/ pathogenicity study did address infectivity sufficiently. Consequently, this study does not satisfy the guideline requirement for an acute pulmonary study (OPPTS 885.3150) in the rat. EPA, in considering the two studies together, believes that there are sufficient data with which to determine the toxicity and pathogenicity of Pseudozyma flocculosa. As any potential inhalation risk that is raised by these studies is primarily a worker risk, EPA is requiring that a respirator be worn by workers to limit any inhalation exposures. In addition, a RestrictedEntry Interval (REI) of 4 hours is required for early entry postapplication workers or other persons entering treated greenhouses. Finally, a confirmatory acute pulmonary toxicity/ pathogenicity study using the TGAI and testing of the sterile filtrate from the production culture will be required as a condition of registration. 4. Intraperitoneal toxicity/ infectivity study (OPPTS 885.3200) (MRID numbers 451152– 08 and 453634– 01). In an acute intraperitoneal toxicity/ infectivity study, groups of young adult CD rats (4/ sex/ scheduled sacrifice date) were exposed by the intraperitoneal route to an undiluted suspension of P. flocculosa (TS) at a dose of 3.5 x 10 7 CFU/ animal (in 1.0 mL). Animals were then observed for up to 14 days. An equal number of young adult CD rats were similarly injected with heat killed test substance (KTS). An undosed naive control (NC) group consisting of 4 rats/ sex was also included in the study. Cage side observation for clinical symptoms was performed daily and animal body weights and food consumption were monitored. No unscheduled deaths occurred. Designated animals from the TS and KTS groups were sacrificed on days 0, 7, and 14 and gross necropsies were performed. The NC group of animals was sacrificed and necropsied at the end of the 14– day study. Infectivity and clearance were assessed by quantitatively recovering the MPCA from the blood, lungs and lymph nodes, spleen, kidneys, liver, heart, stomach and small intestine, peritoneal fluid, caecum and brain. No adverse clinical signs were observed at any point of the study in any of the groups of rats. Body weight gain of TS dosed male rats was significantly decreased while this group's food consumption was significantly increased compared to NC animals. There was no significant difference between KTS dosed and NC animals in terms of body weight, body weight gain or food consumption. Upon necropsy of TS and KTS dosed animals, white nodules and higher relative spleen weights were observed and attributed to a normal immune response to a foreign substance. The detection of P. flocculosa in the peritoneal fluid lavage of TS dosed male rats was consistent with the method of administration. Clearance of P. flocculosa from all other tissues and fluids occurred by day 7. No test substance was detected from any of the organs of the KTS dosed or NC animals. At the dose administered, P. flocculosa was slightly toxic but not pathogenic to male and female CD rats when introduced by the intraperitoneal route. 5. Acute dermal toxicity/ irritation study (OPPTS 885.3100) (MRID numbers 451152– 09 and 453634– 01). In an acute dermal toxicity study, a single group of New Zealand White rabbits (5/ sex) was dermally exposed to 1.2 x 10 7 CFU P. flocculosa (equivalent to approximately 0.82 0.90 g/ kg bw for males and 0.80 0.91 g/ kg bw for females), for 24 hours to an area equivalent to approximately 10% of the dorsal skin surface. Following exposure, the animals were observed for a period of 14 days. No treatment related signs of toxicity or skin irritation were observed in any animal during the 14– day observation period. At the dose administered, P. flocculosa was not considered toxic or irritating to the skin. 6. Primary eye irritation study (OPPTS 870.2400) (MRID numbers 451152– 10 and 453634– 01). Administration of 0.1 g of Sporodex WP to the eyes of rabbits resulted in slight conjunctival redness in 5/ 6 animals at the 1– hour scoring interval and in 2/ 6 rabbits at the 24– hour scoring interval. By the 48– hour scoring interval, all signs of ocular irritation had subsided. There were no other adverse clinical symptoms or mortalities during the 7– day observation period. The maximum irritation score (MIS) was 1.7 at the 1– hour scoring interval and the maximum average score (MAS) was 0.22 over the 24–, 48– and 72– hour scoring intervals. Based on the MAS, Sporodex WP was classified as minimally irritating. 7. Subchronic, chronic toxicity and oncogenicity. Survival, replication, infectivity, significant toxicity or persistence of the MPCA was not observed in the test animals treated in Tier I acute oral, pulmonary and intravenous toxicity/ infectivity tests.

VerDate Sep< 04> 2002 16: 57 Sep 26, 2002 Jkt 197001 PO 00000 Frm 00110 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 27SER1. SGM 27SER1 60963 Federal Register / Vol. 67, No. 188 / Friday, September 27, 2002 / Rules and Regulations Consequently, higher tier tests involving subchronic and chronic testing, oncogenicity testing, mutagenicity and teratogenicity were not required based on the lack of concerns following analysis of Tier I test results. However, a genotoxicity computer search for Pseudozyma flocculosa was conducted. No reports of mammalian toxicity were found in standard biological, chemical and toxicological abstracts. The applicant included computer literature search results to a number of keywords such as pseudozyma; tilletiopsis, fate, non target, carcin, mutagen; toxic, pathogen, antibiotic, polyen; sporothrix, sporobolomyces, rhodotorula, phyllosphere yeast; carcinog and teratogen. The literature search covered AGRICOLA, Biological Abstracts, CAB Abstracts, CHEMTOX, RTEX and AGRIS databases from 1980 to 1999. 8. Hypersensitivity (dermal sensitization) study (OPPTS 870.2600). The applicant has also submitted an acceptable waiver rationale from conducting a dermal sensitization study based on the assumption that most microorganisms contain substances that could elicit a hypersensitivity response. Pseudozyma flocculosa is considered a potential sensitizing agent, therefore, the statement, `` POTENTIAL SENSITIZER'' is required on the principal display panels of the technical and end use formulation labels. The use of personal protective equipment will also be required to mitigate against potential dermal sensitization in occupationally exposed workers/ handlers. 9. Reports of hypersensitivity incidents (OPPTS 885.3400). Skin sensitizing studies are not considered substitutes for timely reports of hypersensitivity incidents subsequent to registration approval. No adverse effects have been noted among researchers who have worked closely with P. flocculosa strain PF A22 UL for up to 10 years. The applicant will be expected to report any subsequent findings of hypersensitivity or other health incidents to workers, applicators, or bystanders exposed to the MPCA as a condition of registration. Incident reports are to include details such as a description of the MPCA and formulation, frequency, duration and routes of exposure to the material, clinical observations, and any other relevant information. 10. Effects on the immune systems (OPPTS 880.3800, immune response). The active ingredient, P. flocculosa strain PF A22 UL, is not known to be a human pathogen nor an endocrine disrupter. The submitted toxicity/ pathogenicity studies in the rodent indicate that, following several routes of exposure, the immune system is still intact and able to process and clear the active ingredient. Therefore, no adverse effects to the immune systems are known or expected. Based on this rationale, the registrant waiver request for OPPTS 880.3800 (Immune Response) was found to be acceptable.

V. Aggregate Exposures A. Dietary Exposure In examining aggregate exposure, FFDCA section 408 directs EPA to consider available information concerning exposures from the pesticide residue in food and all other nonoccupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses). 1. Food. The proposed food use pattern is likely to result in residues in or on food and feed. Residues of the microbial pesticide are likely to be removed from treated food by washing, peeling, cooking and processing. Even if residues are not removed, however, EPA believes that dietary exposure to the microbial agent will result in negligible to no risk to consumers. Although Pseudozyma species are ubiquitous in nature and have been isolated from a wide variety of plant surfaces including leaf litter, clover, maize and cucumber, no adverse effects from dietary exposure have been attributed to natural populations of Pseudozyma flocculosa. Furthermore, no adverse effects were observed at maximum hazard dose levels in the acute oral toxicity/ pathogenicity study and there are no reports of known mammalian toxins being produced by the MPCA. Subchronic and chronic dietary exposure studies were not required because the Tier I acute oral study demonstrated a low level of toxicity and no pathogenicity potential for the active microorganism. Because of the low toxicity profile and low potential exposure of the MPCA expected for the proposed uses, there is no concern for chronic risks posed by dietary exposure for the general population or sensitive subpopulations, such as infants and children. In addition, an extensive literature search yielded no reports of mammalian toxins being produced by P. flocculosa. The fungitoxic unsaturated C 17 fatty acids and acyclic norterpene produced by the MPCA have not been reported to be toxic to mammals. Neither this organism nor its close relatives are listed among microbial contaminants of food. Therefore, EPA expects negligible to no dietary risk from exposure to naturally occurring and isolated P. flocculosa strain PF A22 UL residues. 2. Drinking water exposure. Although heavy rainfall likely carries P. flocculosa into neighboring aquatic environments, growth and survival of terrestrial fungi such as P. flocculosa is limited in such environments. Thus, it is not expected to proliferate in aquatic habitats following incidents of direct or indirect exposure (e. g., runoff from treated greenhouses). Moreover, P. flocculosa is not considered to pose a risk to humans from exposure to drinking water because of minimal to non existent toxicity. Accordingly, drinking water is not specifically screened for P. flocculosa as a potential indicator of microbial contamination or as a direct pathogenic contaminant. Both percolation through soil and municipal treatment of drinking water would reduce the possibility of significant transfer of residues to drinking water. Therefore, the potential of exposure and risk via drinking water is likely to be minimal to non existent for this MPCA.

B. Other Non Occupational Exposure The current label does not allow applications to turf, residential or recreational areas. Because the use sites are in greenhouses, exposure to the U. S. population including infants and children in school, residential and daycare facilities is likely to be minimal to non existent. Consequently, the health risk posed by P. flocculosa strain PF A 22 UL from non occupational dermal and inhalation exposures to the general public, including infants and children, is expected to be negligible to non existent. Any concerns for potential inhalation risk is for occupational exposures, and as mentioned previously, will be mitigated by the requirement of a respirator and restriction of the reentry interval.

VI. Cumulative Effects The Agency has considered available information on the cumulative effects of such residues and other substances that have a common mechanism of toxicity. These considerations included the cumulative effects on infants and children of such residues and other substances with a common mechanism of toxicity. EPA is not aware of any other bacteria or other substances, besides naturally occurring strains of Pseudozyma, that share a common mechanism of toxicity with this active ingredient. Given the low toxicity and pathogenicity profile of P. flocculosa, even if there were any other substances with which P. flocculosa shared a VerDate Sep< 04> 2002 16: 57 Sep 26, 2002 Jkt 197001 PO 00000 Frm 00111 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 27SER1. SGM 27SER1 60964 Federal Register / Vol. 67, No. 188 / Friday, September 27, 2002 / Rules and Regulations common mechanism of toxicity, no adverse cumulative effects are expected.

VII. Determination of Safety for U. S. Population, Infants and Children Based on the toxicology data submitted and other relevant information in the Agency's files, there is reasonable certainty no harm will result from aggregate exposure of residues of Pseudozyma flocculosa strain PF A22 UL to the U. S. population, including infants and children, under reasonably foreseeable circumstances when the microbial pesticide product is used as labeled. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has arrived at this conclusion based on data submitted demonstrating low toxicity at the maximum doses tested and a lack of information showing adverse effects from exposure to naturally occurring P. flocculosa as well as a consideration of the product as currently registered and labeled. As a result, EPA establishes an exemption from tolerance requirements pursuant to FFDCA 408( c) and (d) for residues of Pseudozyma flocculosa strain PF A22 UL in or on all food commodities. FFDCA section 408 provides that EPA shall apply an additional tenfold margin of exposure (safety) for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA determines that a different margin of exposure (safety) will be safe for infants and children. Margins of exposure (safety) are often referred to as uncertainty (safety) factors. In this instance, based on all the available information, the Agency concludes that P. flocculosa strain PFA22 UL is practically non toxic to mammals, including infants and children. Thus, there are no threshold effects of concern and, as a result the provision requiring an additional margin of safety does not apply. Further, the provisions of consumption patterns, special susceptibility, and cumulative effects do not apply. As a result, EPA has not used a margin of exposure (safety) approach to assess the safety of P. flocculosa strain PF A22 UL.

VIII. Other Considerations A. Endocrine Disruptors EPA does not have any information regarding endocrine effects of this microbial pesticide at this time. There is no evidence to suggest that use of P. flocculosa strain PF A22 UL at the proposed concentrations will adversely affect the endocrine system. The active ingredient, P. flocculosa strain PF A22 UL, is not known to be a human pathogen nor an endocrine disrupter. The submitted toxicity/ pathogenicity studies in the rodent indicate that, following several routes of exposure, the immune system is still intact and able to process and clear the active ingredient. Therefore, no adverse effects to the endocrine systems are known or expected.

B. Analytical Method( s) As part of the standard Quality Control measures, the Agency is requiring microbial assays and analytical methods to identify the active ingredient and potential contaminants. Analytical methods are available and sufficient to identify metabolites and contaminants within regulatory levels. All batches containing potential human pathogens are to be destroyed. The MPCA is identified using a combination of morphological traits, molecular techniques and biological activity. The identification of Pseudozyma to the species level is done using a standard mycological approach. Pseudozyma species can be differentiated from morphologically similar species such as Hyalodendron, Tilletiopsis, Sporobolomyces and Sporothrix. The branching conidiophores of Pseudozyma can be confused with those produced by Hyalodendron; however, the whole cell hydrolysates of this filamentous basidiomycete contain xylose which is not found in Pseudozyma. Tilletiopsis and Sporobolomyces, other saprophytic wild yeasts on aerial plant surfaces, are different from Pseudozyma in that they produce spores that are forcibly discharged upon sporulation (ballistospores). Furthermore, Tilletiopsis species produce a fungusdegrading b 1,3 glucanase that is not produced by Pseudozyma species. The genus Sporothrix represents a group of anamorphic ascomycetous yeasts such as Sporothrix schenckii (type), an animal pathogen. Physiologically, Pseudozyma species differ greatly from Sporothrix species. Unlike the ascomycetous Sporothrix anamorphs, P. flocculosa shows positive reactions in Diazonium Blue B and urease tests typical of all basidiomycetous yeasts. Also, the major ubiquinone is Q 10 rather than Q 8 or Q 9 typical of the ascomycetes, Saccharomycopsis and Stephanoascus. Strain PF A22 UL can be differentiated from other strains of P. flocculosa using a DNA based technique called multiplex polymerase chain reaction (multiplex PCR). The multiplex PCR system is essentially a cocktail of different primers which allows the rapid assessment of numerous DNA fragments in a single PCR amplification. The protocol is based on the amplification of two nuclear regions, (ITS and NS), and one mitochondrial region (ML). Those regions were found to be discriminant in the identification of P. flocculosa PFA22 UL. The integrity and consistency of the MPCA is ensured by two methods. The first method is a DNA based PCR technique called random amplified microsatellites PCR (RAMS). Microsatellites are hypervariable noncoding regions of DNA within the genome that evolve more rapidly than coding DNA. The other method is a bioassay that measures biological activity. The biological activity of the MPCA is measured by the inhibition zone created when a susceptible organism is grown next to it. Given that the pest controlled, Sphaerotheca species, is an obligate biotroph, it cannot be used directly in this bioassay. Instead, a Phomopsis species is used because its sensitivity to P. flocculosa's fungitoxic secretions is similar.

C. Codex Maximum Residue Level There are no Codex Maximum Residue Levels or exemption from tolerances for the microbial active ingredient Pseudozyma flocculosa strain PF A22 UL.

IX. Objections and Hearing Requests Under section 408( g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408( g) provides essentially the same process for persons to `` object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408( d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing? You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part VerDate Sep< 04> 2002 16: 57 Sep 26, 2002 Jkt 197001 PO 00000 Frm 00112 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 27SER1. SGM 27SER1 60965 Federal Register / Vol. 67, No. 188 / Friday, September 27, 2002 / Rules and Regulations 178. To ensure proper receipt by EPA, you must identify docket ID number OPP– 2002– 0233 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before November 26, 2002. 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues( s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. 104, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (703) 603– 0061. 2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33( i) or request a waiver of that fee pursuant to 40 CFR 180.33( m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P. O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it `` Tolerance Petition Fees. '' EPA is authorized to waive any fee requirement `` when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection. '' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305– 5697, by e mail at tompkins. jim@ epa. gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit IX. A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I. B. 2. Mail your copies, identified by docket ID number OPP– 2002– 0233, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I. B. 2. You may also send an electronic copy of your request via e mail to: oppdocket epa. gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/ 8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing? A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues( s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

X. Regulatory Assessment Requirements This final rule establishes an exemption from the tolerance requirement under FFDCA section 408( d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U. S. C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104– 4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104– 113, section 12( d) (15 U. S. C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408( d), such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U. S. C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on 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, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications. '' `` Policies that have federalism implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects 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. '' This final rule directly regulates growers, food processors, food handlers and food VerDate Sep< 04> 2002 16: 57 Sep 26, 2002 Jkt 197001 PO 00000 Frm 00113 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 27SER1. SGM 27SER1 60966 Federal Register / Vol. 67, No. 188 / Friday, September 27, 2002 / Rules and Regulations retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408( n)( 4). For these same reasons, the Agency has determined that this rule does not have any `` tribal implications '' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications. '' `` Policies that have tribal implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. '' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

XI. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a `` major rule'' as defined by 5 U. S. C. 804( 2).

List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: September 19, 2002. James Jones, Acting Director, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180—[ AMENDED]

1. The authority citation for part 180 continues to read as follows:

Authority: 21 U. S. C. 321( q), 346( a) and 374.

2. Section 180.1221 is added to subpart D to read as follows:

§ 180.1221 Pseudozyma flocculosa strain PF A22 UL; exemption from the requirement of a tolerance.

An exemption from the requirement of a tolerance is established for residues of Pseudozyma flocculosa strain PF A22 UL in or on all food commodities.

[FR Doc. 02– 24651 Filed 9– 26– 02; 8: 45 am]

BILLING CODE 6560– 50– S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [OPP– 2002– 0229; FRL– 7196– 8]

Fenamidone; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes tolerances for residues of fenamidone, [4H Imidazol 4 one, 3,5 dihydro 5 methyl 2( methylthio) 5 phenyl 3 (phenylamino), (S)], in or on lettuce, head at 15 ppm and lettuce, leaf at 20 ppm. Aventis CropScience requested these tolerances under the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996. Subsequent to the filing of this petition, Bayer Corporation acquired Aventis CropScience to form Bayer CropScience. Therefore, the registrant is now Bayer CropScience.

DATES: This regulation is effective September 27, 2002. Objections and requests for hearings, identified by docket control number OPP– 2002– 0229, must be received on or before November 26, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by mail, in person, or by courier. Please follow the detailed instructions for each method as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your objections and hearing requests must identify docket control number OPP– 2002– 0229 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: Cynthia Giles Parker, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305– 7740; e mail address: giles parker. cynthia@ epa. gov. SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

Categories NAICS codes Examples of potentially affected entities Industry 111 112 311 32532 Crop production Animal production Food manufacturing Pesticide manufacturing This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select `` Laws and Regulations, '' `` Regulations and Proposed Rules, '' and then look up the entry for this document under the `` Federal Register— Environmental Documents. '' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml 00/ Title 40/ 40cfr180 00. html, a VerDate Sep< 04> 2002 16: 57 Sep 26, 2002 Jkt 197001 PO 00000 Frm 00114 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 27SER1. SGM 27SER1


[Federal Register: November 9, 2010 (Volume 75, Number 216)]
[Notices]
[Page 68802-68806]
[DOCID:fr09no10-68]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0369]

Report on the Performance of Drug and Biologics Firms in
Conducting Postmarketing Requirements and Commitments; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: Under the Food and Drug Administration Modernization Act of
1997 (Modernization Act), the Food and Drug Administration (FDA) is
required to report annually in the Federal Register on the status of
postmarketing requirements and commitments required of, or agreed upon
by, holders of approved drug and biological products. This notice is
the Agency's report on the status of the studies and clinical trials
that applicants have agreed to or are required to conduct.

FOR FURTHER INFORMATION CONTACT: Cathryn C. Lee, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6464, Silver Spring, MD 20993-0002, 301-
796-0700; or
    Robert Yetter, Center for Biologics Evaluation and Research (HFM-
25), Food and Drug Administration, 1400 Rockville Pike, Rockville, MD
20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

A. The Modernization Act

    Section 130(a) of the Modernization Act (Pub. L. 105-115) amended
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding a new
provision requiring reports of certain postmarketing studies, including
clinical trials, for human drug and biological products (section 506B
of the FD&C Act (21 U.S.C. 356b)). Section 506B of the FD&C Act
provides FDA with additional authority to monitor the progress of a
postmarketing study or clinical trial that an applicant has been
required to or has agreed to conduct by requiring the applicant to
submit a report annually providing information

on the status of the postmarketing study/clinical trial. This report
must also include reasons, if any, for failure to complete the study/
clinical trial. These studies and clinical trials are intended to
further define the safety, efficacy, or optimal use of a product and
therefore play a vital role in fully characterizing the product.
    Under the Modernization Act, commitments to conduct postmarketing
studies or clinical trials included both studies/clinical trials that
applicants agreed to conduct as well as studies/clinical trials that
applicants were required to conduct under FDA regulations.\1\
---------------------------------------------------------------------------

    \1\ Before passage of FDAAA, FDA could require postmarketing
studies and clinical trials under the following circumstances: To
verify and describe clinical benefit for a human drug approved in
accordance with the accelerated approval provisions in section
506(b)(2)(A) of the FD&C Act (21 U.S.C. 356(b)(2)(A); 21 CFR 314.510
and 601.41); for a drug approved on the basis of animal efficacy
data because human efficacy trials are not ethical or feasible (21
CFR 314.610(b)(1) and 601.91(b)(1)); and for marketed drugs that are
not adequately labeled for children under section 505B of the FD&C
Act (Pediatric Research Equity Act (21 U.S.C. 355c; Public Law 108-
155)).
---------------------------------------------------------------------------

B. The Food and Drug Administration Amendments Act of 2007

    On September 27, 2007, the President signed Public Law 110-85, the
Food and Drug Administration Amendments Act of 2007 (FDAAA). Section
901, in Title IX of FDAAA, created a new section 505(o) of the FD&C Act
authorizing FDA to require certain studies and clinical trials for
human drug and biological products approved under section 505 of the
FD&C Act or section 351 of the Public Health Service Act. Under FDAAA,
FDA has been given additional authority to require applicants to
conduct and report on postmarketing studies and clinical trials to
assess a known serious risk, assess signals of serious risk, or
identify an unexpected serious risk related to the use of a product.
This new authority became effective on March 25, 2008. FDA may now take
enforcement action against applicants who fail to conduct studies and
clinical trials required under FDAAA, as well as studies and clinical
trials required under FDA regulations (see sections 505(o)(1), 502(z),
and 303(f)(4) of the FD&C Act; 21 U.S.C. 355(o)(1), 352(z), and
333(f)(4)).
    Although regulations implementing the Modernization Act
postmarketing authorities use the term ``postmarketing commitment'' to
refer to both required studies and studies applicants agree to conduct,
in light of the new authorities enacted in FDAAA, FDA has decided it is
important to distinguish between enforceable postmarketing requirements
and unenforceable postmarketing commitments. Therefore, in this notice
and report, FDA refers to studies/clinical trials that an applicant is
required to conduct as ``postmarketing requirements'' (PMRs) and
studies/clinical trials that an applicant agrees to but is not required
to conduct as ``postmarketing commitments'' (PMCs). Both are addressed
in this notice and report.

C. FDA's Implementing Regulations

    On October 30, 2000 (65 FR 64607), FDA published a final rule
implementing section 130 of the Modernization Act. This rule modified
the annual report requirements for new drug applications (NDAs) and
abbreviated new drug applications (ANDAs) by revising Sec.
314.81(b)(2)(vii) (21 CFR 314.81(b)(2)(vii)). The rule also created a
new annual reporting requirement for biologics license applications
(BLAs) by establishing Sec.  601.70 (21 CFR 601.70). The rule described
the content and format of the annual progress report, and clarified the
scope of the reporting requirement and the timing for submission of the
annual progress reports. The rule became effective on April 30, 2001.
The regulations apply only to human drug and biological products that
are approved under NDAs, ANDAs, and BLAs. They do not apply to animal
drugs or to biological products regulated under the medical device
authorities.
    The reporting requirements under Sec. Sec.  314.81(b)(2)(vii) and
601.70 apply to PMRs and PMCs made on or before the enactment of the
Modernization Act (November 21, 1997), as well as those made after that
date. Therefore, studies and clinical trials required under FDAAA are
covered by the reporting requirements in these regulations.
    Sections 314.81(b)(2)(vii) and 601.70 require applicants of
approved drug and biological products to submit annually a report on
the status of each clinical safety, clinical efficacy, clinical
pharmacology, and nonclinical toxicology study/clinical trial that is
required by FDA or that they have committed to conduct either at the
time of approval or after approval of their NDA, ANDA, or BLA. The
status of PMCs concerning chemistry, manufacturing, and production
controls and the status of other studies/clinical trials conducted on
an applicant's own initiative are not required to be reported under
Sec. Sec.  314.81(b)(2)(vii) and 601.70 and are not addressed in this
report. It should be noted, however, that applicants are required to
report to FDA on these commitments made for NDAs and ANDAs under Sec.
314.81(b)(2)(viii). Furthermore, section 505(o)(3)(E) of the FD&C Act
as amended by FDAAA requires that applicants report periodically on the
status of each required study/clinical trial and each study/clinical
trial ``otherwise undertaken * * * to investigate a safety issue * *
*.''
    According to the regulations, once a PMR has been required or a PMC
has been agreed upon, an applicant must report on the progress of the
PMR/PMC on the anniversary of the product's approval until the PMR/PMC
is completed or terminated and FDA determines that the PMR/PMC has been
fulfilled or that the PMR/PMC is either no longer feasible or would no
longer provide useful information. The annual progress report must
include a description of the PMR/PMC, a schedule for completing the
PMR/PMC, and a characterization of the current status of the PMR/PMC.
The report must also provide an explanation of the PMR/PMC status by
describing briefly the progress of the PMR/PMC. A PMR/PMC schedule is
expected to include the actual or projected dates for the following:
(1) Submission of the final protocol to FDA, (2) completion of the
study/clinical trial, and (3) submission of the final report to FDA.
The status of the PMR/PMC must be described in the annual report
according to the following definitions:
     Pending: The study/clinical trial has not been initiated
(i.e., no subjects have been enrolled or animals dosed), but does not
meet the criteria for delayed (i.e., the original projected date for
initiation of subject accrual or initiation of animal dosing has not
passed);
     Ongoing: The study/clinical trial is proceeding according
to or ahead of the original schedule;
     Delayed: The study/clinical trial is behind the original
schedule;
     Terminated: The study/clinical trial was ended before
completion, but a final report has not been submitted to FDA; or
     Submitted: The study/clinical trial has been completed or
terminated, and a final report has been submitted to FDA.
    Databases containing information on PMRs/PMCs are maintained at the
Center for Drug Evaluation and Research (CDER) and the Center for
Biologics Evaluation and Research (CBER).

II. Summary of Information From Postmarketing Status Reports

    This report, published to fulfill the annual reporting requirement
under the Modernization Act, summarizes the

status of PMRs and PMCs as of September 30, 2009. If a requirement or
commitment did not have a schedule, or a postmarketing progress report
was not received in the previous 12 months, the PMR/PMC is categorized
according to the most recent information available to the Agency.\2\
---------------------------------------------------------------------------

    \2\ Although the data included in this report do not include a
summary of reports that sponsors have failed to file by their due
date, the Agency notes that it may take appropriate regulatory
action in the event reports are not filed on a timely basis.
---------------------------------------------------------------------------

    Information in this report covers any PMR/PMC that was made, in
writing, at the time of approval or after approval of an application or
a supplement to an application, including PMRs required under FDAAA
(section 505(o)(3) of the FD&C Act), PMRs required under FDA
regulations (e.g., PMRs required to demonstrate clinical benefit of a
product following accelerated approval (see footnote 1 of this
document)), and PMCs agreed to by the applicant.
    Information summarized in this report includes the following: (1)
The number of applicants with open (uncompleted) PMRs/PMCs, (2) the
number of open PMRs/PMCs, (3) the status of open PMRs/PMCs as reported
in Sec.  314.81(b)(2)(vii) or Sec.  601.70 annual reports, (4) the
status of concluded PMRs/PMCs as determined by FDA, and (5) the number
of applications with open PMRs/PMCs for which applicants did not submit
an annual report within 60 days of the anniversary date of U.S.
approval.
    Additional information about PMRs/PMCs submitted by applicants to
CDER and CBER is provided on FDA's Web site at http://www.fda.gov/
Drugs/GuidanceComplianceRegulatoryInformation/Post-
marketingPhaseIVCommitments/default.htm. Neither the Web site nor this
notice include information about PMCs concerning chemistry,
manufacturing, and controls. It is FDA policy not to post information
on the Web site until it has been reviewed for accuracy. Numbers
published in this notice cannot be compared with the numbers resulting
from searches of the Web site because this notice incorporates totals
for all PMRs/PMCs in FDA databases, including PMRs/PMCs undergoing
review for accuracy. In addition, the report in this notice will be
updated annually while the Web site is updated quarterly (i.e., in
January, April, July, and October).
    Many applicants have more than one approved product and for many
products there is more than one PMR or PMC. Specifically, there were
163 unique applicants with 242 NDAs/ANDAs that had open PMRs/PMCs.
There were 59 unique applicants with 91 BLAs that had open PMRs/PMCs.
    Annual status reports are required to be submitted for each open
PMR/PMC within 60 days of the anniversary date of U.S. approval of the
original application. In fiscal year 2009 (FY09), 25 percent (48/193)
of NDA/ANDA and 34 percent (31/91) of BLA annual status reports were
not submitted within 60 days of the anniversary date of U.S. approval
of the original application. Of the annual status reports due but not
submitted on time, 100 percent of the NDA/ANDA and 45 percent (14/31)
of the BLA reports were submitted before the close of FY09 (September
30, 2009).
    Most PMRs are progressing on schedule (91.5 percent for NDAs/ANDAs;
92 percent for BLAs). Most PMCs are also progressing on schedule (89
percent for NDAs/ANDAs; 75 percent for BLAs). Most of the PMCs that are
currently listed in the database were developed before the
postmarketing requirements section of FDAAA took effect.\3\
---------------------------------------------------------------------------

    \3\ There are existing PMCs established before FDAAA that might
meet current FDAAA standards for required safety studies/clinical
trials under section 505(o)(3)(B) of the FD&C Act (21 U.S.C.
355(o)(3)(B)). Under section 505(o)(3)(c), the Agency may convert
pre-existing PMCs into PMRs if it becomes aware of new safety
information.
---------------------------------------------------------------------------

III. About This Report

    This report provides six separate summary tables. The tables
distinguish between PMRs and PMCs and between on-schedule and off-
schedule PMRs and PMCs according to the original schedule milestones.
On-schedule PMRs/PMCs are categorized as pending, ongoing, or
submitted. Off-schedule PMRs/PMCs that have missed one of the original
milestone dates are categorized as delayed or terminated. The tables
include data as of September 30, 2009.
    Table 1 of this document provides an overall summary of the data on
all PMRs and PMCs. Tables 2 and 3 of this document provide detail on
PMRs. Table 2 provides additional detail on the status of on-schedule
PMRs.
    Table 1 shows that most PMRs (91.5 percent for NDAs/ANDAs and 92
percent for BLAs) and most PMCs (89 percent for NDAs/ANDAs and 75
percent for BLAs) are on schedule. Overall, of the PMRs that are
pending (i.e., have not been initiated), 83 percent were created within
the past 3 years. Table 2 shows that 62 percent of pending PMRs for
drug and biological products are in response to the Pediatric Research
and Equity Act (PREA), under which FDA requires sponsors to study new
drugs, when appropriate, for pediatric populations. Under section
505B(a)(3) of the FD&C Act, the initiation of these studies generally
is deferred until required safety information from other studies has
first been submitted and reviewed. PMRs for products approved under the
animal efficacy rule (21 CFR 314.600 for drugs; 21 CFR 601.90 for
biological products) can be conducted only when the product is used for
its indication as a counterterrorism measure. In the absence of a
public health emergency, these studies/clinical trials will remain
pending indefinitely. The next largest category of pending PMRs for
drug and biological products (35 percent) comprises those studies/
clinical trials required by FDA under FDAAA, which became effective on
March 25, 2008.
    Table 3 provides additional detail on the status of off-schedule
PMRs. The majority of off-schedule PMRs (which account for 8.5 percent
of the total for NDAs/ANDAs and 9 percent for BLAs) are delayed
according to the original schedule milestones (94 percent (31/33) for
NDAs/ANDAs; 88 percent (\7/8\) for BLAs). In certain situations, the
original schedules may have been adjusted for unanticipated delays in
the progress of the study/clinical trial (e.g., difficulties with
subject enrollment in a trial for a marketed drug or need for
additional time to analyze results). In this report, study/clinical
trial status reflects the status in relation to the original study/
clinical trial schedule regardless of whether FDA has acknowledged that
additional time may be required to complete the study/clinical trial.
    Tables 4 and 5 of this document provide additional detail on the
status of PMCs. Table 4 provides additional detail on the status of on-
schedule PMCs. Pending PMCs comprise 52 percent (449/867) of the on-
schedule NDA and ANDA PMCs and 34 percent (82/244) of the on-schedule
BLA PMCs.
    Table 5 provides additional details on the status of off-schedule
PMCs. The majority of off-schedule PMCs (which account for 11 percent
for NDAs/ANDAs and 25 percent for BLAs) are delayed according to the
original schedule milestones (90 percent (100/111) for NDAs/ANDAs; 98
percent (79/81) for BLAs). As noted above, this report reflects the
original due dates for study/clinical trial results and does not
reflect discussions between the Agency and the sponsor regarding
studies/clinical trials that may require more time for completion.
    Table 6 of this document provides details about PMRs and PMCs that
were concluded in the previous year. Most concluded PMRs and PMCs were
fulfilled (60 percent of NDA/ANDA PMRs and 56 percent of BLA PMRs; 79

percent of NDA/ANDA PMCs and 82 percent of BLA PMCs). Compared to FY08,
in FY09 there has been a significant increase in the number of
concluded PMRs and the number of concluded PMCs for drug and biological
products.

     Table 1--Summary of Postmarketing Requirements and Commitments
                   [Numbers as of September 30, 2009]
------------------------------------------------------------------------
                                  NDA/ANDA  (% of     >BLA  (% of total
                                 total PMR  or % of   PMR  or % of total
                                     total PMC)            PMC)\1\
------------------------------------------------------------------------
Number of open PMRs...........                  405                   96
    On-schedule open PMRs (see          372 (91.5%)             88 (92%)
     table 2 of this document)
    Off-schedule open PMRs                33 (8.5%)               8 (9%)
     (see table 3 of this
     document)................
Number of open PMCs...........                  978                  325
    On-schedule open PMCs (see            867 (89%)            244 (75%)
     table 4 of this document)
    Off-schedule open PMCs                111 (11%)             81 (25%)
     (see table 5 of this
     document)................
------------------------------------------------------------------------
\1\ On October 1, 2003, FDA completed a consolidation of certain
  therapeutic products formerly regulated by CBER into CDER.
  Consequently, CDER now reviews many BLAs. Fiscal year statistics for
  postmarketing requirements and commitments for BLAs reviewed by CDER
  are included in BLA totals in this table.

       Table 2--Summary of On-Schedule Postmarketing Requirements
                   [Numbers as of September 30, 2009]
------------------------------------------------------------------------
                                  NDA/ANDA  (% of      BLA  (% of total
     On-schedule open PMRs           total PMR             PMR) \1\
------------------------------------------------------------------------
Pending (by type):
    Accelerated approval......                    6                    4
    PREA \2\..................                  185                   26
    Animal efficacy \3\.......                    2                    0
    FDAAA safety (since March                    85                   35
     25, 2008)................
                               -----------------------------------------
        Total.................          278 (68.5%)             65 (68%)
Ongoing:
    Accelerated approval......                   16                    5
    PREA \2\..................                   23                    5
    Animal efficacy \3\.......                    0                    0
    FDAAA safety (since March                    19                    9
     25, 2008)................
                               -----------------------------------------
        Total.................             58 (14%)             19 (20%)
Submitted:
    Accelerated approval......                    8                    0
    PREA \2\..................                   23                    4
    Animal efficacy \3\.......                    0                    0
    FDAAA safety (since March                     5                    0
     25, 2008)................
                               -----------------------------------------
        Total.................              36 (9%)               4 (4%)
                               -----------------------------------------
          Combined total......          372 (91.5%)             88 (92%)
------------------------------------------------------------------------
\1\ See note 1 for table 1 of this document.
\2\ Many PREA studies have a pending status. PREA studies are usually
  deferred because the product is ready for approval in adults.
  Initiation of these studies also may be deferred until additional
  safety information from other studies has first been submitted and
  reviewed.
\3\ PMRs for products approved under the animal efficacy rule (21 CFR
  314.600 for drugs; 21 CFR 601.90 for biological products) can be
  conducted only when the product is used for its indication as a
  counterterrorism measure. In the absence of a public health emergency,
  these studies/clinical trials will remain pending indefinitely.

       Table 3--Summary of Off-Schedule Postmarketing Requirements
                   [Numbers as of September 30, 2009]
------------------------------------------------------------------------
                                  NDA/ANDA  (% of      BLA  (% of total
    Off-schedule open PMRs           total PMR)            PMR) \1\
------------------------------------------------------------------------
Delayed
    Accelerated approval......                    3                    2
    PREA......................                   28                    5
    Animal efficacy...........                    0                    0
    FDAAA safety (since March                     0                    0
     25, 2008)................
                               -----------------------------------------
        Total.................              31 (8%)              7 (12%)
                               -----------------------------------------
Terminated....................             2 (0.5%)               1 (1%)
                               -----------------------------------------

    Combined total............                   33                    8
                                             (8.5%)                 (9%)
------------------------------------------------------------------------
\1\ See note 1 for table 1 of this document.

        Table 4--Summary of On-Schedule Postmarketing Commitments
                   [Numbers as of September 30, 2009]
------------------------------------------------------------------------
                                  NDA/ANDA  (% of      BLA  (% of total
     On-Schedule Open PMCs           total PMC)            PMC) \1\
------------------------------------------------------------------------
Pending.......................            449 (46%)             82 (25%)
Ongoing.......................            147 (15%)             84 (26%)
Submitted.....................            271 (28%)             78 (24%)
                               -----------------------------------------
    Combined total............            867 (89%)           244 (75%)
------------------------------------------------------------------------
\1\ See note 1 for table 1 of this document.

       Table 5--Summary of Off-Schedule Postmarketing Commitments
                   [Numbers as of September 30, 2009]
------------------------------------------------------------------------
                                  NDA/ANDA  (% of      BLA  (% of total
    Off-Schedule Open PMCs           total PMC)            PMC) \1\
------------------------------------------------------------------------
Delayed.......................            100 (10%)             79 (24%)
Terminated....................              11 (1%)               2 (1%)
                               -----------------------------------------
    Combined total............            111 (11%)             81 (25%)
------------------------------------------------------------------------
\1\ See note 1 for table 1 of this document.

Table 6--Summary of Concluded Postmarketing Requirements and Commitments
                  [October 1, 2008 to October 1, 2009]
------------------------------------------------------------------------
                                  NDA/ANDA  (% of     BLA  (% of total)
                                       total)                \1\
------------------------------------------------------------------------
Concluded PMRs:
    Requirement met                        28 (60%)              5 (56%)
     (fulfilled)..............
    Requirement not met                     7 (15%)              2 (22%)
     (released and new revised
     requirement issued)......
    Requirement no longer                  12 (25%)              2 (22%)
     feasible or product
     withdrawn (released).....
                               -----------------------------------------
        Total.................                   47                    9
Concluded PMCs:
    Commitment met (fulfilled)            259 (79%)             32 (82%)
    Commitment not met                      21 (6%)                    0
     (released and new revised
     requirement/commitment
     issued)..................
    Commitment no longer                   48 (15%)              7 (18%)
     feasible or product
     withdrawn (released).....
                               -----------------------------------------
        Total.................                  328                   39
------------------------------------------------------------------------
\1\ See note 1 for table 1 of this document.

    Dated: November 3, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-28193 Filed 11-8-10; 8:45 am]
BILLING CODE 4160-01-P