[Federal Register Volume 78, Number 82 (Monday, April 29, 2013)]
[Notices]
[Page 25071]
[FR Doc No: 2013-09968]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: CP13-127-000.
    Applicants: Equitrans, L.P.
    Description: Equitrans, L.P.'s Abbreviated Application for Order
Authorizing Abandonment of Service.
    Filed Date: 4/9/13.
    Accession Number: 20130409-5079.
    Comments Due: 5 p.m. ET 4/29/13.

    Docket Numbers: CP13-165-000.
    Applicants: Equitrans, L.P.
    Description: Equitrans, L.P. Abbreviated Application for Order
Authorizing Abandonment of Service of Equitrans, L.P.
    Filed Date: 4/12/13.
    Accession Number: 20130412-5172.
    Comments Due: 5 p.m. ET 4/29/13.

    Docket Numbers: CP13-138-000.
    Applicants: Equitrans, L.P.
    Description: Abbreviated Application for Certificate of Public
Convenience and Necessity to Lease Pipeline Facilities and for Related
Authorizations.
    Filed Date: 4/10/13.
    Accession Number: 20130410-5117.
    Comments Due: 5 p.m. ET 5/10/13.

    Docket Numbers: CP13-139-000.
    Applicants: Peoples Natural Gas Company LLC and Rager Mountain
Storage Company LLC.
    Description: Abbreviated Joint Application of Peoples Natural Gas
Company LLC and Rager Mountain Storage Company LLC to abandon pipeline
facility by transfer and amending certificated of public convenience
and necessity.
    Filed Date: 4/10/13.
    Accession Number: 20130410-5123.
    Comments Due: 5 p.m. ET 5/10/13.

    Docket Numbers: RP13-670-000.
    Applicants: Trunkline LNG Company LLC.
    Description: Trunkline LNG Company LLC submits a compliance filing.
    Filed Date: 3/1/13.
    Accession Number: 20130304-0202.
    Comments Due: 5 p.m. ET 4/26/13.

    Docket Numbers: RP13-799-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: 04/17/12 Negotiated Rates--United Energy Trading, LLC
(HUB) 5095-89 to be effective 5/1/2013.
    Filed Date: 4/17/13.
    Accession Number: 20130417-5035.
    Comments Due: 5 p.m. ET 4/29/13.

    Docket Numbers: RP13-802-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Non-Conforming TSAs and Minor Housekeeping to be
effective 5/20/2013.
    Filed Date: 4/19/13.
    Accession Number: 20130419-5167.
    Comments Due: 5 p.m. ET 5/1/13.

    Docket Numbers: RP13-803-000.
    Applicants: Northern Natural Gas Company.
    Description: 20130419 Negotiated Rate to be effective 4/20/2013.
    Filed Date: 4/19/13.
    Accession Number: 20130419-5188.
    Comments Due: 5 p.m. ET 5/1/13.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP13-665-001.
    Applicants: Columbia Gulf Transmission, LLC.
    Description: TRA Supplemental Compliance Filing.
    Filed Date: 4/17/13.
    Accession Number: 20130417-5193.
    Comments Due: 5 p.m. ET 4/29/13.

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, and service can be found at:
http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other
information, call<PHONE_NUMBER> (toll free). For TTY, call (202) 502-
8659.

    Dated: April 22, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-09968 Filed 4-26-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 124 (Wednesday, June 29, 2022)]
[Notices]
[Page 38736]
[FR Doc No: 2022-13883]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers:
    RP22-988-000.
    Applicants: RH energytrans, LLC.
    Description: Request for Waiver of Requirement to File FL&U
Percentage Adjustment of RH energytrans, LLC.
    Filed Date: 6/16/22.
    Accession Number: 20220616-5194.
    Comment Date: 5 p.m. ET 6/28/22.

    Docket Numbers: RP22-990-000.
    Applicants: WBI Energy Transmission, Inc.
    Description: Sec.  4(d) Rate Filing: 2022 Negotiated and Non-
Conforming SA ONEOK to be effective 8/1/2022.
    Filed Date: 6/23/22.
    Accession Number: 20220623-5016.
    Comment Date: 5 p.m. ET 7/5/22.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 23, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-13883 Filed 6-28-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 51 (Monday, March 16, 2020)]
[Notices]
[Pages 14937-14938]
[FR Doc No: 2020-05308]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER20-1209-000]

Neighborhood Sun Benefit Corp; 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
Neighborhood Sun Benefit Corp'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 March 30, 2020.
    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_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: March 10, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-05308 Filed 3-13-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 67 (Tuesday, April 7, 2020)]
[Notices]
[Page 19570]
[FR Doc No: 2020-07222]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2019-0242]

Agency Information Collection Activities; Extension of a
Currently-Approved Information Collection Request: Hazardous Materials
Safety Permits

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FMCSA
announces its plan to submit the Information Collection Request (ICR)
described below to the Office of Management and Budget (OMB) for its
review and approval. The FMCSA requests approval to revise and extend
an existing ICR titled, ``Hazardous Materials Safety Permits.'' This
ICR requires companies holding safety permits to develop communications
plans that allow for the periodic tracking of the shipments. A record
of the communications that includes the time of the call and location
of the shipment may be kept by either the driver (e.g., recorded in the
log book) or the company. These records must be kept, either physically
or electronically, for at least six months at the company's principal
place of business or readily available to the employees at the
company's principal place of business. In response to the 60-day
Federal Register Notice published on November 7, 2019, FMCSA received
one comment that did not relate to this ICR.

DATES: Please send your comments by May 7, 2020. OMB must receive your
comments by this date in order to act on the ICR.

ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Ms. Suzanne Rach, Office of
Enforcement and Compliance, Hazardous Materials Division, Department of
Transportation, FMCSA, West Building 6th Floor, 1200 New Jersey Avenue
SE, Washington, DC 20590. Telephone:<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Title: Hazardous Materials Safety Permits.
    OMB Control Number: 2126-0030.
    Type of Request: Revision and Extension of a currently-approved
information collection.
    Respondents: Motor carriers subject to the HM Safety Permit
requirements in 49 CFR part 385, subpart E.
    Estimated Number of Respondents: 987.
    Estimated Time per Response: 5 minutes. The communication between
motor carriers and their drivers must take place at least two times per
day. It is estimated that it will take 5 minutes to maintain a daily
communication record for each driver.
    Expiration Date: August 31, 2020.
    Frequency of Response: On occasion.
    Estimated Total Annual Burden: 692,000 hours [8.3 million trips x 5
minutes per record / 60 minutes per hour = 691,667 rounded to 692,000].
    Background: The Secretary of Transportation is responsible for
implementing regulations to issue safety permits for transporting
certain hazardous materials (HM) in accordance with 49 U.S.C. 5101 et
seq. The HM Safety Permit regulations (49 CFR part 385, subpart E)
require carriers to develop and maintain route plans so that law
enforcement officials can verify the correct location of the HM
shipment. The FMCSA requires companies holding safety permits to
develop a communications plan that allows for the periodic tracking of
the shipment. This ICR covers the record of communications that
includes the time of the call and location of the shipment. The records
may be kept by either the driver (e.g., recorded in the log book) or
the company. These records must be kept, either physically or
electronically, for at least six months at the company's principal
place of business or be readily available to employees at the company's
principal place of business. The currently-approved information
collection is based on an estimated 1,304 respondents. The total number
of companies now holding a safety permit is 987 therefore in this ICR
the estimated number of respondents is being revised to reflect this
number.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including: (1) Whether the proposed
collection is necessary for the performance of FMCSA's functions; (2)
the accuracy of the estimated burden; (3) ways for FMCSA to enhance the
quality, usefulness, and clarity of the collected information; and (4)
ways that the burden could be minimized without reducing the quality of
the collected information.

    Issued under the authority of 49 CFR 1.87.
Kenneth H. Riddle,
Acting Associate Administrator, Office of Registration and Research.
[FR Doc. 2020-07222 Filed 4-6-20; 8:45 am]
BILLING CODE 4910-EX-P


Meeting with ExxonMobil Chemical Co. February 19, 2004 Participants ExxonMobil: Bob Begbie EPA: Jeff Cohen, Suzie Kocchi This meeting was requested by ExxonMobil to provide EPA an update on the status of the transition from HCFC 141b to alternatives in the foam industry. ExxonMobil met with EPA to talk about the status of the transition, post HCFC 141b production phase out and the continued import of HCFC 141b to the US through blended systems from Mexico. ExxonMobil noted the availability of spray foam equipment capable of handling all alternatives to HCFC 141b, including Exxsol Blowing Agents and HFC 245fa from at least two different manufacturers. Also, ExxonMobil stated that the industry would likely not complete the transition to alternatives as long as HCFC 141b was available either in stockpiles or through the import of blended systems from Mexico.

EPA informed ExxonMobil it is considering ways to address the import of blended systems containing HCFC 141b from Mexico, including finalizing the 2000 proposed ban on the use of HCFC 141b in all foam blowing applications.


TO:

FROM:

SUBJECT: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1 . WASHINGTON, D. C. 20460 January 14,2002 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES John Schaeffkr /M e t7 CITBKCD I DOC t 4 Addendum Moditication to ECA for 1, l ,2 Trichloroethane (TCE) CAS NO. 79 00 5.

Attached is the signed addendum modification for the above referenced project.

N cr W N 48828888815 internet Address (URL) http:// w. epa. gov RecycledlRecyclable Printed wlh Vegetable 011 Based Inks on Recycled Paper (Minimum 25% Postconsumer) OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Dr. Peter Voytek HAP Task Force Manager P. O. Box 331 Millwood, VA 22646 RE: Request for Modifications (OPPTS Docket # 4219SCI Dear Dr. Voytek:

EPA is in. receipt of your letter dated September 14,2001, requesting a modification to the Enforceable Consent Agreement (ECA) for l, l, 2 Trichloroethane (TCE), Specifically the request is to amend, by 45 days, the deadlines for submitting a final report for the acute inhalation toxicity testing, and fgr submitting the pharmacokinetic data to support model vahdation and verification of extrapolation capabilities. The adjustment in reporting deadlines is necessary because of a prior (EPA approved) change in the dose levels for the. acute inhalation study, which occurred after the study was ongoing.

EPA believes that this modification to the test schedule is both necessary and minor and will not have, an adverse effect on the results expected from the testing specified in the ECA for TCE. Therefore, by this letter EPA approves the HAP TaskForce request that Table I of the ECA be modified to provide an additionaI 45 days for the submission of the final report for the acute inhalation toxicity test and the pharmacokinetics data.

The requested modification changes the ECA adding 45 days to the following reporting requirements (Table 1):

FROM: TIER I HAPS Testing Test Standard DeadIine for Final Report (Months) Acute Toxicity (inhalation) §. 799.9135 (as annotated 15 in Appendix B. I)

TO: TIER I HAPS Testing Acute Toxicity (inhalation) Test Standard 3. 799.9135 (as annotated in Appendix B. 1) Deadline for Final Report (Months) 15 (f 45 days)

Internet Address (URL) * http:// www. opa. gov Recycled/ Recyclable o Printed with Vegetable Oil Based Inks o'n Recycled Paper (Minimum 25% Postconsumer) and FROM: TIER I Program Review Test Standard Deadline for Final Testing PK/ MECH data to Supportmodel Appendix C( 1  3) Report (Months) 15 validation and verification of oral .

to inhalation extrapolation for the following data needs in the F344 rat.....

TO: PIUMECH da& to support model Appendix C( 1 3) vaIidation and verification of oral to inhalation extrapoIation for the following data needs in the mouse . . . . . .

TIER I Program Review Testing Test Standard PK/ MECH data to support model validation and verification of oral to inhalatidn extrapolation for the following data needs in the F344. rat..... Appendix C( l  3)

PK/ MECH data to support model validation and verification of oral to inhalation extrapolation for the following data needs in, the mouse Appendix C( l 3) 15 (+ 4.5 days)

. . . . . . 15 Deadline for Final Report (Months) 15 (+ 4.5 days)

This modification is considered to be a minok change for which public comment is not required. Please sign and return the enclosed addendum to the Enforceable Consent Agreement 3 fo; 1,1,2& chloroethane. This signed document will be submitted to the above referenced EPA Docket. Please call John Schaeffer (202 260 1266) or Richard Leukroth (202 260 032 1) if you have any questions.

Chemical Control Division Attachment cc: Docket OPPTS 42198C Francisca Liam (2225A) JohnSch~~~~~~~~~~~:,:; Richard Leukroth (7405) Addendum Modification to ENFORCEABLE CONSENT AGREEMENT FOR 1,1,2 Trichloroethane (TCE) CAS No. 79 00 5 Docket No. ,OPPTS  421986 We the undersigned agree to the change to the Enforceable Consent Agreement for 1,1,2 Trichoroethane as described in the table below: Original Language (in Table 1 of the ECA):

TIER I HAPS Testing Test Standard Deadline for Final Report (Months) Acute Toxicity (inhalation) 5. 799.9135 (as annotated in Appendix B . 1) 15 . . . . . . . . . . . .

TIER I Program Review Testing PWMECH data to support model validation and verification of oral to inhalation extrapolation for the following data needs in the F344 rat..... Test Standard Appendix C( l  3) Deadline for Final Report (Months) 15 PWMECH data to support model validation and verification of oral to inhalation extrapolation for the following data needs in the mouse Appendix C( 1 3) 15 . . . . . .

New, Amended, Language (in Table 1 of the ECA):

TIER I HAPS Testing Test Standard Deadline for Final Report (Months) Acute Toxicity (inhalation) 9. 799.9135 (as annotated in Appendix B. 1) 15 (+ 45 days)

a...........

TIER I Program Review Testing PUMECH data to support model validation and verification of oral to inhalation extrapolation for the following data needs in the F344 rat..... Test Standard Appendix C( 1  3) Deadline for Final Report (Months) 15 (+ 45 days)

PWMECH data to support model validation and verification of oral :o inhalation extrapolation for the following data needs in the mouse Appendix C( 1 3) 15 (f 45 days)

. . . . . .

Charles M. Auer, Director Chemical Control Division Date HAP Task Force Sponsor Representative


[Federal Register: September 2, 2009 (Volume 74, Number 169)]
[Notices]
[Page 45436]
[DOCID:fr02se09-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the-Record Communications; Public Notice

August 26, 2009.
    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication, and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e)(1)(v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped bydocket numbers in ascending order. These filings are
available for review at the Commission in the Public Reference Room or
may be viewed on the Commission's Web site at http://www.ferc.gov using
the eLibrary link. Enter the docket number, excluding the last three
digits, in the docket number field to access the document. For
assistance, please contact FERC, Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.

----------------------------------------------------------------------------------------------------------------
                Docket No.                    File date                    Presenter or requestor
----------------------------------------------------------------------------------------------------------------
Prohibited:
    1. IN09-9-000........................         8-24-09  John H. Pound.
Exempt:
    1. CP08-431-000......................        07-28-09  Hon. Sherrod Brown.
    2. P-400-051.........................        08-05-09  Greg Stobb, Edwin Schlapfer.
    3. P-405-087.........................        08-03-09  Hon. Benjamin L. Cardin.
    4. P-12569-001.......................        08-06-09  Gregory Griffith.
    5. P-12569-001.......................        08-04-09  Dan Boettger.
    6. P-12737-002.......................        08-06-09  Brenda Winn.
----------------------------------------------------------------------------------------------------------------

Kimberly D. Bose,
Secretary.
[FR Doc. E9-21113 Filed 9-1-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: November 3, 2008 (Volume 73, Number 213)]
[Notices]
[Page 65385-65386]
[DOCID:fr03no08-50]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0565]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on Formal Dispute Resolution;
Appeals Above the Division Level

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
contained in the guidance for industry on formal dispute resolution.

DATES: Submit written or electronic comments on the collection of
information by January 2, 2009.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance for Industry on Formal Dispute Resolution; Appeals Above the
Division Level (OMB Control Number 0910-0430)--Extension

    This information collection approval request is for an FDA guidance
on the process for formally resolving scientific and procedural
disputes in the Center for Drug Evaluation and Research (CDER) and the
Center for Biologics Evaluation and Research (CBER) that cannot be
resolved at the division level. The guidance describes procedures for
formally appealing such disputes to the office or center level and for
submitting information to assist center officials in resolving the
issue(s) presented. The guidance provides information on how the agency
will interpret and apply provisions of the existing regulations
regarding internal agency review of decisions (Sec.  10.75) and dispute
resolution during the investigational new drug (IND) process (Sec.
312.48) and the new drug application/abbreviated new drug application
(NDA/ANDA) process (Sec.  314.103). In addition, the guidance provides
information on how the agency will interpret and apply the specific
Prescription Drug User Fee Act (PDUFA) goals for major dispute
resolution associated with the development and review of PDUFA
products.
    Existing regulations, which appear primarily in parts 10, 312, and
314 (21 CFR parts 10, 312, and 314), establish procedures for the
resolution of scientific and procedural disputes between interested
persons and the agency, CDER, and CBER. All agency decisions on such
matters are based on information in the administrative file (Sec.
10.75(d)). In general, the information in an administrative file is
collected under existing regulations in parts 312 (OMB Control No.
0910-0014), 314 (OMB Control No. 0910-0001), and part 601 (21 CFR part
601) (OMB Control No. 0910-0338), which specify the information that
manufacturers must submit so that FDA may properly evaluate the safety
and effectiveness of drugs and biological products. This information is
usually submitted as part of an IND, NDA, or biologics license
application (BLA), or as a supplement to an approved application. While
FDA already possesses in the administrative file the information that
would form the basis of a decision on a matter in dispute resolution,
the submission of particular information regarding the request itself
and the data and information relied on by the requestor in the appeal
would facilitate timely resolution of the dispute. The guidance
describes the following collection of information not expressly
specified under existing regulations: The submission of the request for
dispute resolution as an amendment to the application for the
underlying product, including the submission of supporting information
with the request for dispute resolution.
    Agency regulations (Sec. Sec.  312.23(11)(d), 314.50, 314.94, and
601.2) state that information provided to the agency as part of an IND,
NDA, ANDA, or BLA is to be submitted in triplicate and with an
appropriate cover form. Form FDA 1571 must accompany submissions under
INDs and Form FDA 356h must accompany submissions under NDAs, ANDAs,
and BLAs. Both forms have valid OMB control numbers as follows: FDA
Form 1571 - OMB Control No. 0910-0014, and FDA Form 356h - OMB Control
No. 0910-0338.
    In the guidance document, CDER and CBER ask that a request for
formal dispute resolution be submitted as an amendment to the
application for the underlying product and that it be

submitted to the agency in triplicate with the appropriate form
attached, either Form FDA 1571 or Form FDA 356h. The agency recommends
that a request be submitted as an amendment in this manner for two
reasons: (1) To ensure that each request is kept in the administrative
file with the entire underlying application and (2) to ensure that
pertinent information about the request is entered into the appropriate
tracking databases. Use of the information in the agency's tracking
databases enables the appropriate agency official to monitor progress
on the resolution of the dispute and to ensure that appropriate steps
will be taken in a timely manner.
    CDER and CBER have determined and the guidance recommends that the
following information should be submitted to the appropriate center
with each request for dispute resolution so that the Center may quickly
and efficiently respond to the request: (1) A brief but comprehensive
statement of each issue to be resolved, including a description of the
issue; the nature of the issue (i.e., scientific, procedural, or both);
possible solutions based on information in the administrative file;
whether informal dispute resolution was sought prior to the formal
appeal; whether advisory committee review is sought; and the expected
outcome; (2) a statement identifying the review division/office that
issued the original decision on the matter and, if applicable, the last
agency official that attempted to formally resolve the matter; (3) a
list of documents in the administrative file, or additional copies of
such documents, that are deemed necessary for resolution of the
issue(s); and (4) a statement that the previous supervisory level has
already had the opportunity to review all of the material relied on for
dispute resolution. The information that the agency suggests submitting
with a formal request for dispute resolution consists of: (1)
Statements describing the issue from the perspective of the person with
a dispute, (2) brief statements describing the history of the matter,
and (3) the documents previously submitted to FDA under an OMB approved
collection of information.
    Based on FDA's experience with dispute resolution, the agency
expects that most persons seeking formal dispute resolution will have
gathered the materials listed previously when identifying the existence
of a dispute with the agency. Consequently, FDA anticipates that the
collection of information attributed solely to the guidance will be
minimal.
    Description of Respondents: A sponsor, applicant, or manufacturer
of a drug or biological product regulated by the agency under the
Federal Food, Drug, and Cosmetic Act or section 351 of the Public
Health Service Act who requests formal resolution of a scientific or
procedural dispute.
    Burden Estimate: Provided in table 1 of this document is an
estimate of the annual reporting burden for requests for dispute
resolution. Based on data collected from review divisions and offices
within CDER and CBER, FDA estimates that approximately 13 sponsors and
applicants (respondents) submit requests for formal dispute resolution
to CDER annually and approximately 1 respondent submits requests for
formal dispute resolution to CBER annually. The total annual responses
are the total number of requests submitted to CDER and CBER in 1 year,
including requests for dispute resolution that a single respondent
submits more than one time. FDA estimates that CDER receives
approximately 22 requests annually and CBER receives approximately 1
request annually. The hours per response is the estimated number of
hours that a respondent would spend preparing the information to be
submitted with a request for formal dispute resolution in accordance
with the guidance, including the time it takes to gather and copy brief
statements describing the issue from the perspective of the person with
the dispute, brief statements describing the history of the matter, and
supporting information that has already been submitted to the agency.
Based on experience, FDA estimates that approximately 8 hours on
average would be needed per response. Therefore, FDA estimates that 184
hours will be spent per year by respondents requesting formal dispute
resolution under the guidance.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                           No. of        No. of Responses  per      Total Annual        Hours Per
       Requests for Formal Dispute Resolution           Respondents            Respondent            Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDER                                                                13                      1.7                 22                  8                176
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CBER                                                                 1                        1                  1                  8                  8
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Total                                                                                184
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

    Dated: October 23, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-26095 Filed 10-31-08; 8:45 am]

BILLING CODE 4160-01-S