[Federal Register Volume 80, Number 29 (Thursday, February 12, 2015)]
[Notices]
[Page 7872]
[FR Doc No: 2015-02910]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]

Joint Meeting of the Cellular, Tissue and Gene Therapies Advisory
Committee and the Oncologic Drug Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.

    Name of Committee: Cellular, Tissue and Gene Therapies Advisory
Committee and the Oncologic Drug Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on April 29, 2015, from 8
a.m. to 6 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: Janie Kim or Rosanna Harvey, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Silver Spring, MD 20993-0002,<PHONE_NUMBER> or
240-402-8072, email<EMAIL_ADDRESS>or
<EMAIL_ADDRESS>or FDA Advisory Committee Information Line,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area). A notice in the Federal Register
about last minute modifications that impact a previously announced
advisory committee meeting cannot always be published quickly enough to
provide timely notice. Therefore, you should always check the Agency's
Web site at http://www.fda.gov/AdvisoryCommittees/WhatsNew/default.htm
and scroll down to the appropriate advisory committee meeting link, or
call the advisory committee information line to learn about possible
modifications before coming to the meeting.
    Agenda: The committees will discuss talimogene laherparepvec,
Amgen, Inc., biologics license application (BLA) 125518, an oncolytic
immunotherapy for the treatment of patients with injectable regionally
or distantly metastatic melanoma.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/default.htm. Scroll down to the appropriate
advisory committee meeting link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
April 15, 2015. Oral presentations from the public will be scheduled
between approximately 11:40 a.m. to 12:40 p.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before April 7, 2015. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by April 8, 2015.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Janie Kim at least 7
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: February 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02910 Filed 2-11-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 217 (Monday, November 13, 2017)]
[Rules and Regulations]
[Pages 52207-52209]
[FR Doc No: 2017-24366]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2014-F-0988]

Food Additives Permitted in Feed and Drinking Water of Animals;
Ammonium Formate and Formic Acid

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, we, the Agency) is
amending food additive regulations for food additives permitted in feed
and drinking water of animals to provide for the safe use of formic
acid and ammonium formate. This action is in response to a food
additive petition filed by BASF Corp for Feed Grade Sodium Formate (FAP
2286), which also proposed to amend the animal food additive
regulations for formic acid and ammonium formate to limit formic acid
and formate salts from all added sources.

DATES: This rule is effective November 13, 2017. Submit either written
or electronic objections and requests for a hearing by December 13,
2017. See section V of this document for information on the filing of
objections.

ADDRESSES: You may submit objections and requests for a hearing as
follows. Please note that late, untimely filed objections will not be
considered. Electronic objections must be submitted

on or before December 13, 2017. The https://www.regulations.gov
electronic filing system will accept objections until midnight Eastern
Time at the end of December 13, 2017. Objections received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting objections. Objections submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your objection will be
made public, you are solely responsible for ensuring that your
objection does not include any confidential information that you or a
third party may not wish to be posted, such as medical information,
your or anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your objection, that information will be
posted on https://www.regulations.gov.
     If you want to submit an objection with confidential
information that you do not wish to be made available to the public,
submit the objection as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper objections submitted to the Dockets
Management Staff, FDA will post your objection, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-F-0988 for ``Food Additives Permitted in Feed and Drinking
Water of Animals; Ammonium Formate and Formic Acid.'' Received
objections, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit an objection with
confidential information that you do not wish to be made publicly
available, submit your objections only as a written/paper submission.
You should submit two copies in total. One copy will include the
information you claim to be confidential with a heading or cover note
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The
Agency will review this copy, including the claimed confidential
information, in its consideration of objections. The second copy, which
will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your objections and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper objections received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Chelsea Trull, Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In a document published in the Federal Register of July 25, 2014
(79 FR 43325), FDA announced that we had filed a food additive petition
(animal use) (FAP 2286) submitted by BASF Corp., 100 Park Ave., Florham
Park, NJ 07932. The petition proposed that the regulations for food
additives permitted in feed and drinking water of animals be amended to
provide for the safe use of feed grade sodium formate as a feed
acidifying agent in complete swine feeds. The notice of petition
provided for a 30-day comment period on the petitioner's request for
categorical exclusion from preparing an environmental assessment or
environmental impact statement.
    In addition, the petition proposed that the animal food additive
regulations for formic acid and ammonium formate be amended to limit
formic acid and formate salts from all added sources to 1.2 percent of
complete feeds. This element of the petition was not described in the
July 2014 notice of petition for FAP 2286, but was later described in a
September 30, 2016, notice of petition (81 FR 67260).

II. Conclusion

    FDA became concerned about the safety of higher levels of formic
acid and formate salts in complete feeds when multiple sources of
formic acid and its salts are used in combination. FDA concludes that
the data establish the safety of formic acid and ammonium formate for
use as a feed acidifying agent in complete feeds, that formic acid and
formate salts should be limited to 1.2 percent on complete feed, and
that the food additive regulations should be amended as set forth in
this document.

III. Public Disclosure

    In accordance with Sec.  571.1(h) (21 CFR 571.1(h)), the petition
and documents we considered and relied upon in reaching our decision to
approve the petition will be made available for public disclosure (see
FOR FURTHER INFORMATION CONTACT). As provided in Sec.  571.1(h), we
will delete from the documents any materials that are not available for
public disclosure.

IV. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.32(r) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment, nor an environmental impact statement is required.

V. Objections and Hearing Requests

    Any person who will be adversely affected by this regulation may
file with the Dockets Management Staff (see ADDRESSES) either
electronic or written objections. Each objection shall be separately
numbered, and each numbered objection shall specify with particularity
the provision of the

regulation to which objection is made and the grounds for the
objection. Each numbered objection on which a hearing is requested
shall specifically so state. Failure to request a hearing for any
particular objection shall constitute a waiver of the right to a
hearing on that objection. Each numbered objection for which a hearing
is requested shall include a detailed description and analysis of the
specific factual information intended to be presented in support of the
objection in the event that a hearing is held. Failure to include such
a description and analysis for any particular objection shall
constitute a waiver of the right to a hearing on the objection.
    Any objections received in response to the regulation may be seen
in the office of the Dockets Management Staff between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at
https://www.regulations.gov.

List of Subjects in 21 CFR Part 573

    Animal feeds, Food additives.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
573 is amended as follows:

PART 573--FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF
ANIMALS

0
1. The authority citation for part 573 continues to read as follows:

    Authority:  21 U.S.C. 321, 342, 348.

0
2. In Sec.  573.170, redesignate paragraphs (c) and (d) as paragraphs
(d) and (e), add new paragraph (c) and paragraph (d)(3) to newly
redesignated paragraph (d), and revise newly redesignated paragraph (e)
introductory text to read as follows:

Sec.  573.170  Ammonium formate.

* * * * *
    (c) To ensure safe use of the additive, formic acid and formate
salts from all added sources cannot exceed 1.2 percent of complete feed
when multiple sources of formic acid and its salts are used in
combination.
* * * * *
    (d) * * *
    (3) Cautions for use including this statement: Caution: Follow
label directions. Formic acid and formate salts from all added sources
cannot exceed 1.2 percent of complete feed when multiple sources of
formic acid and its salts are used in combination.
    (e) To ensure safe use of the additive, in addition to the other
information required by the Federal Food, Drug, and Cosmetic Act and
paragraph (d) of this section, the label and labeling shall contain:
* * * * *

0
3. In Sec.  573.480, redesignate paragraphs (b)(3) and (4) as
paragraphs (b)(4) and (5), add new paragraph (b)(3) and paragraph
(b)(4)(iii) to newly redesignated paragraph (b)(4), and revise newly
redesignated paragraph (b)(5) introductory text to read as follows:

Sec.  573.480  Formic acid.

* * * * *
    (b) * * *
    (3) To ensure safe use of the additive, formic acid and formate
salts from all added sources cannot exceed 1.2 percent of complete feed
when multiple sources of formic acid and its salts are used in
combination.
    (4) * * *
    (iii) Cautions for use including this statement: Caution: Follow
label directions. Formic acid and formate salts from all added sources
cannot exceed 1.2 percent of complete feed when multiple sources of
formic acid and its salts are used in combination.
    (5) To ensure safe use of the additive, in addition to the other
information required by the Federal Food, Drug, and Cosmetic Act and
paragraph (b)(4) of this section, the label and labeling shall contain:
* * * * *

    Dated: November 3, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24366 Filed 11-9-17; 8:45 am]
BILLING CODE 4164-01-P


1 Minimum Information About a Microarray Experiment   MIAME for Toxicogenomics ( MIAME/ Tox)

DRAFT   Based on MIAME 1.1 ( February 12, 2003)

Background: MIAME and MIAME/ Tox The MIAME/ Tox document is based on the MIAME 1.1 document[ 1] produced by the MGED ( microarray gene expression database) Society[ 2]. The goal of MIAME ( minimum information about microarray experiment)[ 3] is to outline the minimum information required to interpret unambiguously and potentially reproduce and verify an array based gene expression monitoring experiment. Although details for particular experiments may be different, MIAME aims to define the core that is common to most experiments. MIAME is not a formal specification, but a set of guidelines. More information about the MIAME rationale can be found in ` Minimum information about a microarray experiment ( MIAME)   toward standards for microarray data', A. Brazma, et al., Nature Genetics, vol 29 ( December 2001), pp 365  371)[ 3]. Although MIAME concentrates on information content and should not be confused with a data format, it also tries to provide a conceptual structure for microarray experiment descriptions. Similarly, MIAME/ Tox seeks to provide such a conceptual structure in the context of toxicogenomics.

In addition to MIAME, a standard microarray data model and exchange format MAGE)[ 4], which is able to capture information specified by MIAME, has been submitted by EBI ( for MGED)) and Rosetta Biosoftware)[ 5] and recently became an Adopted Specification of the OMG standards group[ 6] ( see http:// www. mged. org/ mage). Many organizations, ( including Agilent, Affymetrix), and Iobion), have contributed ideas to MAGE. MAGE collectively refers to the MAGE OM ( object model) and MAGE ML[ 7] ( markup language) derived from the model. MAGE OM is able to capture information specified by MIAME and will be the standard microarray data model, while MAGE ML is the standard exchange format.

The response of the microarray community to MIAME has been very favourable and many instrument manufacturers, software developers, and international databases have moved to adapt their systems to capture and manage MIAMEcompliant data. Links to software tools supporting the MIAME information capture and management are available from http:// www. mged. org/ miame.

An open letter has been sent to the main scientific journals by the MGED Society and published by Nature [ 8], Science, The Lancet and Bioinformatics [ 9]. The letter includes a guide to authors, editors and reviewers of microarray gene expression papers. The guidelines, based on the MIAME document, aim to help authors to meet the requirements. They also guide editors or reviewers in their evaluation of 2 whether or not a manuscript provides as much information as necessary for others to replicate and interpret the analysis presented. Finally, the letter suggests that journals should require submission of data to either of the two public repositories: ArrayExpress [ 10] and GEO [ 11]. The Nature group, The Lancet, Cell, EMBO and Toxicology Pathology have responded accordingly, by requiring an accession number to be supplied at or before acceptance of publication.

Although details for particular toxicogenomic experiments as published in the literature may be different, MIAME/ Tox, like MIAMI, aims to define the core that is common to most toxicogenomic experiments. Here, for MIAME/ Tox, the original MIAME 1.1 document has been adapted and extended to fulfill the need of toxicogenomics data capture and exchange. Like MIAME, MIAME/ Tox is not a formal specification, but a set of guidelines. MIAME/ Tox supports a number of different objectives, for example: linking data within a study, and linking several studies from one institution and exchanging toxicogenomics datasets among public databases. In fact, the major objective of MIAME/ Tox is to guide the development of toxicogenomics databases and data management software. Efforts to build international public toxicogenomics databases are underway at the National Center for Toxicogenomics [ 12] National Institute of Environmental Health Sciences, USA and at the EMBL European Bioinformatics Institute ( EBI) [ 13], UK in conjunction with the International Life Sciences Institute's Health and Environmental Sciences Institute ( ILSI HESI) [ 14], USA. This document addresses this objective by outlining the minimum information required to interpret unambiguously and potentially reproduce and verify array based toxicogenomic experiments.

Toxicogenomics domains Following the MIAME rationale, sufficient and structured information should be recorded for toxicogenomics experiments, to correctly interpret and replicate the experiments or retrieve and analyse the data. Minimum information to be recorded about toxicogenomics experiments is defined in subsequent sections and should include the following data domains:

( 1) Experimental design parameters, animal husbandry information or cell line and culture information, exposure parameters, dosing regimen, dose groups, and in life observations. ( 2) Microarray data, specifying the number and details of replicate array bioassays associated with particular samples, and including PCR transcript analysis if available. ( 3) Numerical biological endpoint data, including necropsy weights or cell counts and doubling times, clinical chemistry and enzyme assays, hematology, urinalysis, other. ( 4) Textual endpoint information such as gross observations, pathology and microscopy findings. 3 The institute and animal number, study number and dates are sufficient identifiers to link data domains from in life studies. In vitro experiments will establish a similar unique identifier for cultures within a study. Linking microarray data to biological endpoint data will be through the individual biological material assay number following MIAME conventions for microarray standard sample extracts.

It should be noted that MIAME only covers array based gene expression experiments. A Proteomics Standards Initiative ( PSI) [ 15], that aims to define community standards for data representation in proteomics to facilitate data comparison, exchange and verification is in a developmental stage. At the present time, no metabonomics standards initiative is known. Therefore, this MIAME/ Tox document presently outlines the requirements for array based toxicogenomic experiments with the expectation that proteomics and metabonomics standards will be introduced very soon.

The MIAME/ Tox Ontologies and Controlled Vocabularies The MGED Society is developing ontology to provide standard terms for the annotation of microarray experiments. The MGED Ontology [ 16, 17] is intended for the use of investigators in annotating their microarray experiments and for software and database developers. These terms will enable structured queries of elements of the experiments and allow unambiguous description of how the experiment was performed. A core MGED Ontology will be established by Sept. 2003, and will remain unchanged to facilitate software applications development. However, as new applications of microarray technology arise, requiring new descriptive terms, a second layer of ontology will be built. The MGED Ontology also participates in the global open biological ontologies effort ( GOBO) [ 18] that collects freely available ontologies for use within the genomics and proteomics domains. Therefore, the MGED Ontology will only include reference to available free resources.

Toxicogenomics applications require specific, common terminologies that need to be identified and subsequently integrated within the MGED Ontology. MIAME/ Tox content areas for gene expression experiment descriptions include sections that will be provided in a free text format, along with information that are recommended to be provided by maximum use of controlled vocabularies or external ontologies ( such as species taxonomy, cell types, anatomy terms, histopathology, toxicology, and chemical compound nomenclature). The use of controlled vocabularies is needed to enable database queries and automated data analysis.

Since few controlled vocabularies have been fully developed, MIAME/ Tox encourages the users, if necessary, to provide their own qualifiers and values identifying the source of the terminology. This is achieved through the use of ( qualifier, value, source)

triplets, for instance,

( qualifier: ` cell type', value: ` epithelial', source: ` Gray's anatomy, 38th ed.'). 4 This is recommended instead or in addition to free text format descriptions wherever possible and will allow the community to build a knowledge base of the most useful controlled vocabularies for describing microarray experiments.

The MIAME/ Tox structure Overview Microarrays are often manufactured independently of particular experiments and their design description can be given separately. Therefore, as with MIAME, MIAME/ Tox has two major sections.

  Array design description;   Gene expression experiment description.

The first section remains identical to the MIAME 1.1 document, and the second section is extended to fulfill the need of this toxicogenomics specific application of MIAME. The two components of MIAME/ Tox are discussed in further detail below.

Array design description The array design specification consists of the description of the common features of the array as the whole, and the description of each array design elements ( e. g., each spot). Following terminology used in MAGE, we distinguish between three levels of array design elements: feature   the location on the array, reporter   the nucleotide sequence present in a particular location on the array, and composite sequence   a set of reporters used collectively to measure an expression of a particular gene, exon, or splice variant. The details that should be given for each of them are described below.

1) Array related information   array design name   platform type: in situ synthesized, spotted or other   surface and coating specification   physical dimensions of array support ( e. g. of slide)   number of features on the array   availability ( e. g., for commercial arrays) or production protocol for custom made arrays 2a) For each reporter type   the type of the reporter: synthetic oligo nucleotides, PCR products, plasmids, colonies, other   single or double stranded 2b) For each reporter 5   sequence or PCR primer information:   sequence or a reference sequence ( e. g., for oligonucleotides), if known   sequence accession number in DDBJ/ EMBL/ GenBank, if exists   primer pair information, if relevant   approximate lengths if exact sequence not known   clone information, if relevant ( clone ID, clone provider, date, availability)   element generation protocol that includes sufficient information to reproduce the element for custom made arrays that are not generally available 3a) For each feature type   dimensions   attachment ( covalent/ ionic/ other)   technology used to generate the feature 3b) For each feature   which reporter and the location on the array 4) For each composite sequence   which reporters it contains   the reference sequence   gene name and links to appropriate databases ( e. g., SWISS PROT, or organism specific databases), if known and relevant 5) Control elements on the array   position of the feature ( the abstract coordinate on the array)   control type ( spiking, normalization, negative, positive)   control qualifier ( endogenous, exogenous)

For each array that is not generally available ( e. g., commercially available), the provided information should be sufficient to reproduce the array and all its design features.

Experiment description By experiment MIAME refers to a set of one or more hybridizations that are in some way related ( e. g., related to the same publication or the same study). The minimum information for a toxicogenomic experiment includes a description of the following five parts.

1. Toxicogenomic experimental design 2. Biological materials used, extract preparation and labeling, toxicological assays. 3. Hybridization procedures and parameters 4. Gene expression measurement data and 6 5. Specifications of data processing Note: A potentially reusable part of the experiment description is ` laboratory protocols,' including data processing methods ( e. g., normalization). MIAME encourages the user to assign unique identifiers to all reusable parts of the experiment description and to reference these when the respective parts are reused ( indicating any deviations). A standard for the description of protocols, including the data transformation protocols is being developed by the MGED Society [ 19];

MIAME/ Tox recommends the following details on each of these sections.

1. Toxicogenomic experimental design This section is common to all hybridizations performed in the toxicogenomic experiment, such as the goal, brief description, experimental factors tested. The following information is included in the experimental design.

1.1 Authors, laboratory, contact 1.2 Type of the experiment for instance:   Acute, pre chronic or chronic treatment   multiple tissue comparison   temperature shock   biomarker identification   normal vs. diseased comparison   treated vs. untreated comparison   time course   dose response   effect of gene knock out   effect of gene knock in ( transgenics)   other.

( Note that multiple types are possible, e. g. an ` acute' experiment can also be a ` dose response' type if multiple doses of the compound are tested)

Also, see http:// www. mged. org/ ontology 1.3 Experimental factors, i. e. organisms, parameters or conditions tested, for instance,   species   strain   sex type 7   age and weight   cell line   cell type   developmental stage   disease state   genotype   protocol   route of exposure   temperature   time of treatments and observations   dose( s) in standard units   genetic variation   response to a treatment or compound   other.

Also, see http:// www. mged. org/ ontology 1.4 How many hybridizations in the experiment?

1.5 If a common ( standard) reference material used for all hybridizations 1.6 Quality control steps taken:   Replicates done ( yes/ no), type of replicates, description   biological   technical   if pools of extracts ( yes/ no) were used versus extracts from individual samples, description   whether dye swap is used ( only for two channel platforms)   other ( e. g., polyA tails, low complexity regions, unspecific binding)   other.

Also, see http:// www. mged. org/ ontology 1.7 A brief description of the experiment and its goal and a link to a publication if one exists 1.8 Links ( URL), citations 2. Biological materials used, extract preparation and labeling, toxicological assays.

By biological material ( sample) MIAME/ Tox refers to the material used in toxicological investigations and from which the nucleic acids were extracted for subsequent labelling and hybridization, and toxicological assays. In this section all 8 steps that precede the hybridization with the array are described. We can usually distinguish between:

Source of the sample ( biosource properties); Treatments applied to the samples ( manipulations); Toxicological assessments; Extract preparation; Extract labelling; and Hybridization controls.

The use of terms from the MGED Ontology is highly encouraged.

Here below we list the most essential items that are usually needed.

2.1 Biosource properties   organism ( NCBI taxonomy)   sample source provider   descriptors relevant to the particular sample, such as sex age weights development stage organism part ( tissue) of the organism's anatomy from which the biological material is derived ( if samples are cells) cell type animal/ plant strain or line genetic variation ( e. g., gene knockout, transgenic variation) individual genetic characteristics ( e. g., disease alleles, polymorphisms) disease state or normal additional clinical information available ( link) an individual identifier ( for interrelation of the biological materials in the experiment)

For recommendations on controlled vocabularies that can be used see http:// www. mged. org/ ontology 2.2 Sample manipulations: laboratory protocols and relevant parameters, such as:   facilities details   animal husbandry and housing details   cell culture conditions   growth conditions ( passage level and frequency)   metabolic competency of cell strains   treatment ( stressor), in vivo, in vitro 9   treatment type ( e. g., compound, small molecule, heat shock, cold shock, food deprivation, diet)   treatment compound name and grade formulation, including manufacturer   type of compound ( e. g. chemical, drug or solvent)   CASRN, chemical structure/ molecular formula   vehicle for chemical treatment   exposure method ( route of administration, e. g. oral, gavage, mucolar, medium, intraperitoneal, intramuscular, intravenous, topical)   duration   dose ( and unit)   separation technique, for tissues or cells from a heterogeneous sample ( e. g., none, trimming, microdissection, FACS)   date/ time at death or at sacrifice   sacrifice method For recommendations on controlled vocabularies that can be used see http:// www. mged. org/ ontology 2.3. Toxicological assessments: laboratory protocols and relevant parameters measured and data files e. g.,

Clinical observations   weight   survival ( yes/ no)   signs ( e. g., general, behavior)   site of application   lesions   color effects   other Gross necropsy examination   organs and tissues examination list   organs and tissues collection list   organs and tissues weight list   organs and tissues storage method and location Histopathology evaluation   which biological materials ( control and experimental)   slide preparation, storage method and location   topography ( definite anatomical region)   system   organ   sites   cell type( s) 10   morphology( s)   qualifier( s) for the morphology( s)

Clinical pathology   hematology ( e. g., erythrocyte count, mean corpuscular volume, hemoglobin)   clinical chemistry ( e. g., sorbitol dehydrogenase ( SDH), alkaline phosphatase ( ALP), creatine kinase ( CK))   other parameters measured, e. g., sperm morphology and vaginal cytology evaluation ( SMVCE)   estrous cycle length   micronucleated erythrocytes determination   functional observation battery   other.

For recommendations on controlled vocabularies to be used, see http:// www. mged. org/ ontology.

Note: Understanding the historical measures made at a given institution may help standardize data and improve comparisons. The medical community uses the INR value ( international normalized ratio) in some cases to compare data from different clinical labs. This is the ratio of experimental finding for the patient compared to standard values obtained in the same lab. Microarray data are reported as ratios from dual channel experiments and as intensity values from oligonucleotide arrays. Clinical data should be reported in comparable ways so that patterns can be detected, e. g., the clinical data may be compared to historical values, or to control values for the particular study. In either case, defining the standard for comparison is important.

2.4 Hybridization extract preparation protocol for each extract prepared from the biological material, including   extraction method   whether total RNA, mRNA, or genomic DNA is extracted   amplification ( RNA polymerases, PCR)

2.5 Labeling protocol for each labeling prepared from the extract, including   amount of nucleic acids labeled   label used ( e. g., A Cy3, G Cy5, 33P,  .)   label incorporation method   Facility details ( if this part of the experiments has been carried out in facility different from the sample treatment and toxicological assessments steps above, e. g. consortium, contracting out.

2.6 External controls added to hybridization extract( s) ( spiking controls)   element on array expected to hybridize to spiking control 11   spike type ( e. g., oligonucleotide, plasmid DNA, transcript)   spike qualifier ( e. g., concentration, expected ratio, labelling methods if different than that of the extract)

3. Hybridization procedures and parameters Each hybridization description should include information about which labelled extract ( related to which biological material, which extract) and which array ( e. g., array design, batch and serial number) has been used in the experiment; and the hybridization protocol, normally including:   the solution ( e. g., concentration of solutes)   blocking agent   wash procedure   quantity of labeled target used   time, concentration, volume, temperature   description of the hybridization instruments 4. Measurement data and specifications of data processing We distinguish between three levels of data processing   raw data ( images), image quantitations and gene expression data matrix. Each hybridization has at least one image, each image has a corresponding image quantitation table, where a row represents an array design element and a column to a different quantitation types, such as mean or median pixel intensity. Several quantitation tables can be combined using data processing metrics to obtain the ` final' gene expression measurement table associated with the experiment. 12 1) Raw data description should include   for each scan laboratory protocol for scanning, including scanning hardware and software, scan parameters, including laser power, spatial resolution, pixel space, PMT voltage;   scanned images; It should be noted that MGED does not have consensus whether the provision of images is a part of MIAME.

2) Image analysis and quantitation   image analysis software specification and version, availability, and the description or identification of the algorithm and all the parameters used   for each image the complete image analysis output ( of the particular image analysis software)

3) Normalized and summarized data   gene expression data matrix data processing protocol, including normalization algorithm ( for detailed recommendations, see http:// www. mged. org/ normalization) gene expression data table( s) derived from the experiment as the whole, derived measurement value summarizing related elements and replicates as used by the author ( this may constitute replicates of the element on the same or different arrays or hybridizations, as well as different elements related to the same entity e. g., gene) providing a reliability indicator for each data point ( e. g., standard deviation) is encouraged. Note that toxicology data may also be normalized to signal, fold change ratios to facilitate comparison to similarly expressed microarray data ( especially when 2 fluor labelling has been used).

This ends the experiment description.

MIAME/ Tox is continuously developing in accordance with our understanding of microarray technology and its applications to toxicology. Please join the MIAME/ Tox discussion list ( mged toxico@ lists. sourceforge. net, to subscribe: http:// lists. sourceforge. net/ lists/ listinfo/ mged toxico) and contribute with your ideas and comments. 13 References [ 1] MIAME 1.1: http:// www. mged. org/ Workgroups/ MIAME/ miame_ 1.1. html [ 2] MGED Society: http:// www. mged. org [ 3] Brazma A et al. ( 2001). Minimum information about a microarray experiment ( MIAME)  toward standards for microarray data. Nature Genetics, 29, 365 371. [ 4] MAGE Adopted Specification: http:// www. omg. org/ techprocess/ meetings/ schedule/ Gene_ Expression_ RFP. html [ 5] Rosetta Biosoftware: http:// www. rosettabio. com/ home. html [ 6] OMG: http:// www. omg. org [ 7] Spellman PT et al. ( 2002). Design and implementation of microarray gene expression markup language ( MAGE ML). Genome Biology, 3( 9), research 0046.1 0046.9. [ 8] Microarray standards at last. Nature 2002 419: 323. [ 9] Ball CA et al. ( 2002). An open letter to the scientific journals. Science, 298( 5593): 539. Bioinformatics, 18( 11): 1409. The Lancet, 360: 1019. [ 10] Brazma A et al. ( 2003) ArrayExpress   a Public Repository for Microarray Gene Expression Data at the EBI ( 2003). Nucleic Acids Res 31 ( 1): 68 71. [ 11] Edgar R et al. ( 2002) Gene Expression Omnibus: NCBI gene expression and hybridization array data repository. Nucleic Acids Research, 30( 1), 207 210. [ 12] NIEHS NCT: http:// www. niehs. nih. gov/ nct/ [ 13] EMBL EBI Microarray Informatics: http:// www. ebi. ac. uk/ microarray/ index. html [ 14] ILSI HESI: http:// hesi. ilsi. org/ [ 15] The Proteomics Standards Initiative ( PSI): http:// psidev. sourceforge. net/ [ 16] Stoeckert CJ et al. ( 2002). Microarray databases: standards and ontologies. Nature Genetics, 32 Suppl: 469 73. [ 17] MGED Society  Ontology: http:// www. mged. org/ ontology [ 18] GOBO: http:// www. geneontology. org/ doc/ gobo. html [ 19] MGED Society  Normalization: http:// www. mged. org/ normalisation 14 MIAME/ Tox Glossary MIAME/ Tox requirements are listed in alphabetical order and definitions are provided.

Amplification method The method used to amplify the nucleic acid extracted Array design The layout or conceptual description of array that can be implemented as one or more physical arrays.

The array design specification consists of the description of the common features of the array as the whole, and the description of each array design elements ( e. g., each spot). There are three levels of array design elements: feature ( the location on the array), reporter ( the nucleotide sequence present in a particular location on the array), and composite sequence ( a set of reporters used collectively to measure an expression of a particular gene)

Array design name Given name and version for the array design, that helps to identify a design between others Array related information Description of the array as the whole Attachment How the element ( reporter) sequences are physically attached to the array ( e. g. covalent, ionic)

Author, laboratory, and contact Person( s) and organization ( s) names and details ( address, phone, FAX, email, URL)

Biological material ( sample) The source material, on which the toxicological investigations have been carried out and from which the nucleic acids have been extracted for subsequent labelling and hybridization, and toxicological assays.

Biosource properties Information on the source of the biological material ( e. g. organism, sample provider, sex, age, weights or cell type, cell line)

Clinical observation Clinical pathology Examination of body tissues and fluids derived from the sample by chemical, physical, microbiological and immunological, methods Clone information For each reporter, the identity of the clone along with information on the clone provider, the date obtained, and availability Common ( standard) reference material Composite sequence The set of reporters used collectively to measure an expression of a particular gene, exon, or splicevariant Control elements ( array) Array elements that have an expected value and/ or are used for normalization Control qualifier ( array) Terms used to further define a control element ( e. g. endogenous, exogenous)

Control type ( array) The type of control used for the normalization ( e. g. spiking, normalization, negative, positive)

Dimensions ( feature) The physical dimensions of each features 15 Element ( array) There are three levels of array design elements: feature ( the location on the array), reporter ( the nucleotide sequence present in a particular location on the array), and composite sequence ( a set of reporters used collectively to measure an expression of a particular gene)

Element generation protocol A description of how the reporters were generated Experiment A set of one or more hybridizations that are in some way related ( e. g., related to the same publication or study).

Experimental factor Parameter or condition tested in the experiment ( e. g. route of exposure, temperature, time, dose)

Extraction method Documentation of the set of steps taken to extract nucleic acids from the biological material Feature ( array) A specific instance of a reporter located on an array, commonly referred to as a spot.

Final gene expression table ( s) Derived measurement value summarizing related elements and replicates, providing the type of reliability indicator used Gross necropsy examination Post mortem examination of the organs and body tissue to determine cause of death or pathological condition Hybridization The process of treating an array with one or more labelled extracts under a specified set of conditions Hybridization extract preparation Information on the extract preparation for each extract prepared from the sample, the type of extract ( e. g.

total RNA, mRNA) and the amplification method used ( e. g. RNA polymerases, PCR)

Hybridization protocol Documentation of the set of steps taken in the hybridization, including: solution ( e. g. concentration of solutes); blocking agent and concentration used; wash procedure; quantity of labelled target used; time;

concentration; volume, temperature, and description of the hybridization instruments Image analysis and quantitation Each image has a corresponding image analysis output from the particular image analysis software. In an image quantitation table a row represents a array design element and a column correspond to a different quantitation types ( e. g. mean or median pixel intensity). This has an associated image analysis protocol,

the set of steps taken to quantify the image including: the image analysis software, the algorithm and all the parameters used Label incorporation method The method used to incorporate the label into the extracts Label used The type of the label used ( e. g. A Cy3, G Cy5, 33P)

Location ( feature) The abstract coordinate of each features on the array Measurements MIAME distinguishes between three levels of data processing: image ( raw data), image analysis and quantitation, gene expression data matrix ( normalized and summarized data)

Normalized and summarized data Several quantitation tables are combined using data processing metrics to obtain the ` final' gene expression measurement table ( gene expression data matrix) associated with the experiment. This has an associated data processing protocol, including normalization algorithm and a reliability indicator for each data point ( e. g., standard deviation). Toxicology data may also be normalized to signal, fold

change ratios to facilitate comparison to similarly expressed microarray data especially for two channel 16 experiments Numerical biological endpoint data Biological endpoint with quantitative measurements ( e. g. clinical pathology)

Physical dimensions ( array) The physical dimension of the array support ( e. g. of slide)

Platform type ( array) The technology type used to place the biological sequence on the array Position ( control elements) The abstract coordinate of each the control features on the array Primer information For each reporter, PCR primers pair sequence and length Production protocol ( array) A description of how the custom made array was manufactured Qualifier, value, source Describe any further information about the array or an experiment in a structured manner Quality control steps Measures taken to ensure or measure quality, e. g., dye swap ( for two channel platforms), biological replicate ( samples taken from more than one organism), technical replicate ( same biological material hybridized to more than one array).

Raw data Each hybridization has at least one image and associated laboratory protocol for scanning, hardware and software, scan parameters ( including laser power, spatial resolution, pixel space and PMT voltage)

Reference sequence ( reporter) The sequence from which the reporter ( e. g. oligo nucleotides) have been derived Reporter The nucleotide sequence present in a feature. The same reporter can be also used at multiple features to generate replicate measurements.

Reporter type Physical nature of the reporter ( e. g. PCR product, synthesized oligo nucleotide, plasmids, colonies)

Scanner image file The TIFF file including header Sequence information ( reporter) The nucleotide sequence information for reporter: sequence accession number ( from DDBJ/ EMBL/ GenBank), the sequence itself ( if known) or a reference sequences ( e. g. for oligonucleotides

Single or double stranded ( reporter) Whether the reporter sequences are single ( oligo nucleotide) or double stranded ( e. g. PCR product)

Spike type and qualifier The type of spike used ( e. g. oligonucleotide, plasmid DNA, transcript) and its qualifier ( e. g. concentration,

expected ratio, labelling methods)

Spiking control ( hybridization) External controls added to the hybridization extract ( s)

Spiking control element ( array) Position of the feature ( s) on the array expected to hybridize to the spiking control Surface and coating specification ( array) Type of surface and name for the type of coating used Textual biological endpoint data Biological endpoint with nominal measurements ( e. g. clinical observations and gross necropsy examination)

Toxicogenomics experiment description MIAME/ Tox distinguishes between: the toxicogenomic experiment design ( the design, purpose common to all hybridizations performed in the experiment and the parameters), the biological material used ( biological material characteristics, the extract preparation and the labelling and the toxicological assays),

the hybridization ( procedures and parameters) and the gene expression data ( measurements and 17 specifications)

Toxicogenomics experimental design Design and purpose common to all hybridizations performed in the experiment, including a brief description, person( s), organization ( s) names and details, type of the experiment, experimental factors,

number of hybridizations, quality controls and link to a publication.

Toxicological assessments Process designed to determine factors contributing to the possible adverse effects of a treatment,

including laboratory protocols, relevant parameters measured and data files for numerical biological endpoint and textual biological endpoint data Type of experiment A controlled vocabulary that classify an experiment ( e. g. acute, pre chronic, chronic)


[Federal Register Volume 78, Number 49 (Wednesday, March 13, 2013)]
[Notices]
[Page 15978]
[FR Doc No: 2013-05753]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension: Form N-14; OMB Control No. 3235-0336; SEC File No. 270-
297.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.) (``Paperwork Reduction Act''), the
Securities and Exchange Commission (the ``Commission'') is soliciting
comments on the collection of information summarized below. The
Commission plans to submit this existing collection of information to
the Office of Management and Budget (``OMB'') for extension and
approval.
    Form N-14 (17 CFR 239.23) is the form for registration under the
Securities Act of 1933 (15 U.S.C. 77a et seq.) (``Securities Act'') of
securities issued by management investment companies registered under
the Investment Company Act of 1940 (15 U.S.C. 80a-1 et seq.)
(``Investment Company Act'') and business development companies as
defined by Section 2(a)(48) of the Investment Company Act in: (1) A
transaction of the type specified in rule 145(a) under the Securities
Act (17 CFR 230.145(a)); (2) a merger in which a vote or consent of the
security holders of the company being acquired is not required pursuant
to applicable state law; (3) an exchange offer for securities of the
issuer or another person; (4) a public reoffering or resale of any
securities acquired in an offering registered on Form N-14; or (5) two
or more of the transactions listed in (1) through (4) registered on one
registration statement. The principal purpose of Form N-14 is to make
material information regarding securities to be issued in connection
with business combination transactions available to investors. The
information required to be filed with the Commission permits
verification of compliance with securities law requirements and assures
the public availability and dissemination of such information. Without
the registration statement requirement, material information may not
necessarily be available to investors.
    We estimate that approximately 139 funds each file one new
registration statement on Form N-14 annually, and that 58 funds each
file one amendment to a registration statement on Form N-14 annually.
Based on conversations with fund representatives, we estimate that the
reporting burden is approximately 620 hours per respondent for a new
Form N-14 registration statement and 300 hours per respondent for
amending the Form N-14 registration statement. This time is spent, for
example, preparing and reviewing the registration statements.
Accordingly, we calculate the total estimated annual internal burden of
responding to Form N-14 to be approximately 103,580 hours. In addition
to the burden hours, based on conversations with fund representatives,
we estimate that the total cost burden of compliance with the
information collection requirements of Form N-14 is approximately
$27,500 for preparing and filing an initial registration statement on
Form N-14 and approximately $16,000 for preparing and filing an
amendment to a registration statement on Form N-14. This includes, for
example, the cost of goods and services purchased to prepare and update
registration statements on Form N-14, such as for the services of
outside counsel. Accordingly, we calculate the total estimated annual
cost burden of responding to Form N-14 to be approximately $4,750,500.
    Estimates of average burden hours are made solely for the purposes
of the Paperwork Reduction Act and are not derived from a comprehensive
or even representative survey or study of the costs of Commission rules
and forms. The collection of information under Form N-14 is mandatory.
The information provided under Form N-14 will not be kept confidential.
An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the Commission's estimate
of the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to Thomas Bayer, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 6432 General Green Way, Alexandria, VA 22312; or send an
email to<EMAIL_ADDRESS>
     Dated: March 6, 2013.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-05753 Filed 3-12-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: March 25, 2009 (Volume 74, Number 56)]
[Proposed Rules]
[Page 12807-12811]
[DOCID:fr25mr09-63]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 67

[Docket ID FEMA-2008-0020; Internal Agency Docket No. FEMA-B-1043]

Proposed Flood Elevation Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Proposed rule.

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

SUMMARY: Comments are requested on the proposed Base (1 percent annual-
chance) Flood Elevations (BFEs) and proposed BFE modifications for the
communities listed in the table below. The purpose of this notice is to
seek general information and comment regarding the proposed regulatory
flood elevations for the reach described by the downstream and upstream
locations in the table below. The BFEs and modified BFEs are a part of
the floodplain management measures that the community is required
either to adopt or show evidence of having in effect in order to
qualify or remain qualified for participation in the National Flood
Insurance Program (NFIP). In addition, these elevations, once
finalized, will be used by insurance agents, and others to calculate
appropriate flood insurance premium rates for new buildings and the
contents in those buildings.

DATES: Comments are to be submitted on or before June 23, 2009.

ADDRESSES: The corresponding preliminary Flood Insurance Rate Map
(FIRM) for the proposed BFEs for each community are available for
inspection at the community's map repository. The respective addresses
are listed in the table below.
    You may submit comments, identified by Docket No. FEMA-B-1043, to
William R. Blanton, Jr., Chief, Engineering Management Branch,
Mitigation Directorate, Federal Emergency Management Agency, 500 C
Street, SW., Washington, DC 20472,<PHONE_NUMBER>, or (e-mail)
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: William R. Blanton, Jr., Chief,
Engineering Management Branch, Mitigation Directorate, Federal
Emergency Management Agency, 500 C Street, SW., Washington, DC 20472,
(202) 646-3151 or (e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) proposes to make determinations of BFEs and modified BFEs for
each community listed below, in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR
67.4(a).
    These proposed BFEs and modified BFEs, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own, or pursuant to policies established
by other Federal, State, or regional entities. These proposed
elevations are used to meet the floodplain management requirements of
the NFIP and are also used to calculate the appropriate flood insurance
premium rates for new buildings built after these elevations are made
final, and for the contents in these buildings.
    Comments on any aspect of the Flood Insurance Study and FIRM, other
than the proposed BFEs, will be considered. A letter acknowledging
receipt of any comments will not be sent.
    National Environmental Policy Act. This proposed rule is
categorically excluded from the requirements of 44 CFR part 10,
Environmental Consideration. An environmental impact assessment has not
been prepared.
    Regulatory Flexibility Act. As flood elevation determinations are
not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-
612, a regulatory flexibility analysis is not required.
    Executive Order 12866, Regulatory Planning and Review. This
proposed rule is not a significant regulatory action under the criteria
of section 3(f) of Executive Order 12866, as amended.
    Executive Order 13132, Federalism. This proposed rule involves no
policies that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This proposed rule
meets the applicable standards of Executive Order 12988.

List of Subjects in 44 CFR Part 67

    Administrative practice and procedure, Flood insurance, Reporting
and recordkeeping requirements.
    Accordingly, 44 CFR part 67 is proposed to be amended as follows:

PART 67--[AMENDED]

    1. The authority citation for part 67 continues to read as follows:

    Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp., p. 376.

Sec.  67.4  [Amended]

    2. The tables published under the authority of Sec.  67.4 are
proposed to be amended as follows:

----------------------------------------------------------------------------------------------------------------
                                                                  * Elevation in feet
                                                                (NGVD)  + Elevation in
                                                                feet (NAVD)
                                                                  Depth in feet above
         Flooding source(s)            Location of referenced       ground  [caret]        Communities affected
                                            elevation**           Elevation in meters
                                                                         (MSL)
                                                              --------------------------
                                                                Effective     Modified
----------------------------------------------------------------------------------------------------------------
                               Cumberland County, Kentucky and Incorporated Areas
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
Cumberland River....................  Approximately 3,300             None         +533  Cumberland County, City
                                       feet downstream of the                             of Burkesville.
                                       confluence with Judio
                                       Creek.
                                      Approximately 1,500             None         +568
                                       feet upstream of the
                                       confluence with Crow
                                       Creek.

Dale Hollow Lake (Obey River).......  Approximately 5,000             None         +663  Cumberland County.
                                       feet downstream
                                       confluence with
                                       Hendricks Creek.
                                      At the confluence with          None         +663  .......................
                                       Illwill Creek.
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES

City of Burkesville

Maps are available for inspection at 600 Courthouse Square, Burkesville, KY 42717.

Cumberland County

Maps are available for inspection at 214 Upper River Street, Burkesville, KY 42717.
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
                            Jefferson Davis Parish, Louisiana and Incorporated Areas
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
Lake Arthur.........................  From the shoreline of             +6        +8-10  Town of Lake Arthur,
                                       and including Lake                                 Unincorporated Areas
                                       Arthur North to 7th                                of Jefferson Davis
                                       Street from the East                               Parish.
                                       to the West border of
                                       the Town of Lake
                                       Arthur.
Lake Charles........................  Covering an area                +5-8        +7-11  Unincorporated Areas of
                                       beginning at the                                   Jefferson Davis
                                       Southern Border with                               Parish.
                                       Cameron Parish,
                                       proceeding North along
                                       the Calcaceus Parish
                                       border to West Niblett
                                       Road, to the East to
                                       State Route 99. From
                                       State Route 99 below
                                       State Route 380 to the
                                       Town of Lake Charles
                                       border.
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES

Town of Lake Arthur

Maps are available for inspection at 102 Arthur Avenue, Lake Arthur, LA 70549.

                                 Unincorporated Areas of Jefferson Davis Parish

Maps are available for inspection at 304 North State Street, Jennings, LA 70546.
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
                                 Laclede County, Missouri and Incorporated Areas
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
Radio Tower Branch..................  Approximately 2,500             None        +1166  City of Lebanon.
                                       feet upstream from the
                                       confluence with
                                       Goodwin Hallow.
                                      Approximately 3,150             None        +1170
                                       feet upstream from the
                                       confluence with
                                       Goodwin Hallow.
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES

City of Lebanon

Maps are available for inspection at 400 S. Madison, Lebanon, MO 65536.
----------------------------------------------------------------------------------------------------------------
                                McDonald County, Missouri and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Beaver Branch.......................  Just downstream of Main         None         +884  City of Anderson,
                                       Street.                                            Unincorporated Areas
                                                                                of McDonald County.
                                      Approximately 1.14              None         +931
                                       miles upstream from
                                       Sellers Street.
Indian Creek........................  Approximately 1.15              None         +868  City of Anderson,
                                       miles downstream from                              Unincorporated Areas
                                       the confluence of Wild                             of McDonald County.
                                       Creek.
                                      Approximately 2.79              None         +923
                                       miles upstream from
                                       Highway 71.
Sugar Tree Branch...................  Just downstream of East         None         +888  City of Anderson,
                                       Street.                                            Unincorporated Areas
                                                                                of McDonald County.
                                      Approximately 1,785             None         +948
                                       feet upstream from
                                       Highway F.
Wild Creek..........................  Approximately 700 feet          None         +878  City of Anderson,
                                       downstream from                                    Unincorporated Areas
                                       Highway 59.                                        of McDonald County.
                                      Approximately 410 feet          None        +1002
                                       upstream from Highway
                                       76.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES

City of Anderson
Maps are available for inspection at 201 West Beaver Street, Anderson, MO 64831.

                                     Unincorporated Areas of Mcdonald County
Maps are available for inspection at 602 Main Street, Pineville, MO 64856.
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
                                    Ross County, Ohio and Incorporated Areas
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
Kinnikinnick Creek..................  1,850 feet upstream             None         +645  Unincorporated Areas of
                                       from the confluence of                             Ross County.
                                       Kinnikinnick Creek and
                                       Scioto River.
                                      11,050 feet upstream            None         +666
                                       from confluence of
                                       Kinnikinnick Creek and
                                       Scioto River.
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES
                                       Unincorporated Areas of Ross County

Maps are available for inspection at 15 N. Paint Street, Chillicothe, OH 45601.
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                                Nacogdoches County, Texas and Incorporated Areas
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
Bayou La Nana.......................  Approximately 1,246             None         +248  Unincorporated Areas of
                                       feet upstream of the                               Nacogdoches County.
                                       confluence with Bayou
                                       La Nana and Egg Nog
                                       Branch.
                                      Approximately 523 feet          None         +255
                                       downstream of Loop 224.
Bayou La Nana.......................  Approximately 921 feet          None         +317  Unincorporated Areas of
                                       upstream of Loop 224.                              Nacogdoches County,
                                                                                City of Nacogdoches.
                                      Just upstream of Old            None         +320
                                       Post Oak Road.

Bonita Creek........................  Approximately 729 feet          None         +355  Unincorporated Areas of
                                       upstream of Loop 224.                              Nacogdoches County,
                                                                                City of Nacogdoches.
                                      Just upstream of U.S.           None         +373
                                       Highway 59.
Egg Nog Branch......................  Approximately 1,246             None         +248  Unincorporated Areas of
                                       feet upstream of the                               Nacogdoches County,
                                       confluence with Egg                                City of Nacogdoches.
                                       Nog Branch and Bayou
                                       La Nana.
                                      Approximately 727 feet          None         +284
                                       downstream of Loop 224.
Toliver Branch......................  Confluence of Bayou La          None         +317  Unincorporated Areas of
                                       Nana and Toliver                                   Nacogdoches County,
                                       Branch.                                            City of Nacogdoches.
                                      Just upstream of Old            None         +320
                                       Post Oak Road.
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES
City of Nacogdoches
Maps are available for inspection at City Hall, 202 East pilar Street, Nacogdoches, TX 75963.

                                   Unincorporated Areas of Nacogdoches County
Maps are available for inspection at 101 W. Main, Nacogdoches, TX 75961.
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                                    Rusk County, Texas and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Unnamed Stream off of Turkey Creek..  At the confluence of            None         +329  City of Henderson.
                                       Turkey Creek and
                                       Unnamed Stream.
                                      Approximately 110 feet          None         +336
                                       downstream from
                                       Florence Street.
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES
City of Henderson
Maps are available for inspection at Town Hall, 400 West Main Street, Henderson, TX 75652.
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                                 Tom Green County, Texas and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Flooding Effects of Red Arroyo......  Just upstream of                None        +1900  City of San Angelo.
                                       Melrose Avenue.
                                      Just downstream of              None        +1922
                                       Burlington Road.
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES
City of San Angelo

Maps are available for inspection at PO BOX 1751, San Angelo, TX 76902.
----------------------------------------------------------------------------------------------------------------

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: March 2, 2009.
Michael K. Buckley,
Acting Assistant Administrator, Mitigation Directorate, Department of
Homeland Security, Federal Emergency Management Agency.
 [FR Doc. E9-6711 Filed 3-24-09; 8:45 am]

BILLING CODE 9110-12-P