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

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer and an electronic cigarette sales employee of 3+ years to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers and knowledged representatives, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life and many others. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.


Barbara Leczynski 06/ 17/ 2003 03: 37 PM To: Mary Dominiak/ DC/ USEPA/ US@ EPA cc: ( bcc: Mary Dominiak/ DC/ USEPA/ US) Subject: PFOA ECA Public Meeting Summary, June 6, 2003 You are receiving this message because you have expressed an interest in receiving information concerning the Agency's enforceable consent agreement ( ECA) process on perfluorooctanoic acid ( PFOA) and the fluorinated telomers, OPPT 2003 0012. If you no longer wish to receive this information, please send an email response to dominiak. mary@ epa. gov requesting that you be removed from this notification list.

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Attached for your information is a brief summary of the public meeting held at EPA Headquarters from noon until 5: 00 PM on June 6, 2003, in Washington, DC, to initiate the PFOA ECA process. Copies of this summary, the draft meeting agenda, the complete attendance list for the meeting, and the four opening statements that were provided at the meeting in writing have been placed in the online electronic docket for this proceeding. A copy of the verbatim transcript of the meeting will be entered into the docket on or before June 27, 2003. You can access the docket at www. epa. gov/ edocket/ by using the " Quick Search" feature to locate docket OPPT 2003 0012. Document processing requirements may delay the visibility of submitted documents in the public docket for one or two days.

If you have any questions concerning this matter, or any difficulty in accessing the electronic docket, please contact Mary Dominiak by phone at 202 564 8104, or by email at dominiak. mary@ epa. gov.

Sincerely,

Barbara Leczynski Chief, Existing Chemicals Branch U. S. Environmental Protection Agency EPA East, Room 4410 A, Mail Code 7405M 1200 Pennsylvania Avenue, NW Washington, DC 20460 Phone: 202 564 8164 Fax: 202 564 4775 PFOA Meeting Summary, June 6, 2003 U. S. Environmental Protection Agency June 16, 2003 Enforceable Consent Agreement Development for Perfluorooctanoic Acid ( PFOA) and Fluorinated Telomers Summary of June 6, 2003 Public Meeting One hundred and ninety one people attended the initial enforceable consent agreement ( ECA) meeting on PFOA and the telomers at EPA Headquarters in Washington, DC on Friday, June 6, 2003, from noon to 5: 00 PM. The meeting participants represented 49 registered interested parties, numerous observers, and EPA staff. Groups speaking at the meeting expressed support for EPA's actions and a willingness to work toward agreements on the data needs identified in EPA's Preliminary Framework document. Copies of the attendance list, the meeting agenda, and the four opening statements submitted in writing to the Agency can be found in the electronic docket, OPPT 2003 0012. A verbatim transcript of the proceedings will be placed in the docket within three weeks of the meeting. The next Plenary meeting will be held in Washington, DC on July 10, 2003.

Summary of Opening Statements EPA and six interested parties made opening statements at the meeting.

° EPA welcomed the meeting participants, provided an overview of the ECA process, and noted that the goal of this process is to obtain agreements to develop data to clarify the sources of PFOA in the environment and the pathways leading to exposure. EPA reiterated statements made in the Federal Register notice and in the preparatory materials for the meeting that the Agency would not be pursuing additional PFOA toxicity testing or blood monitoring through this ECA process. EPA noted that pharmacokinetics studies are already underway in the private sector, and that EPA has nominated PFOA and related chemicals to the Centers for Disease Control and Prevention as candidates to include in the next National Health and Nutrition Examination Survey, which monitors chemicals in human blood. EPA stated that it saw no need to duplicate these activities in the ECA process. EPA also noted that it is continuing its efforts to refine a preliminary risk assessment on PFOA. EPA stated that a further developed, revised version of the preliminary risk assessment would be submitted to the EPA's Science Advisory Board for review later this year, in a public process that will allow for the consideration of issues specific to that assessment, and that the preliminary assessment would thus not be discussed in the context of these ECA proceedings.

° The Center for Regulatory Effectiveness indicated that all information disseminated by the Agency during the ECA process and with regard to the Agency's developing risk assessment on PFOA must meet the requirements of the Agency's information quality guidelines. U. S. Environmental Protection Agency June 16, 2003 2 ° The Little Hocking Water Association commented that its rural water system contains about 2 ppb of PFOA, and that its citizens are thus exposed to PFOA through their water supply. The Association requested that, during this ECA process, the EPA remember this local community and provide data and information in which these citizens can have confidence.

° The Environmental Working Group stated that any CBI claims with respect to PFOA toxicity or exposure data must be denied; that companies must submit to EPA all existing health and exposure data relating to PFOA and telomers; that the ECA process must include blood monitoring studies; and that the ECA process should include PFOA exposure from heated non stick appliances.

° DuPont recognized that many questions have been raised by EPA and others about the potential risks associated with exposure to PFOA, and expressed its commitment to investigate past and current sources of exposure; to further reduce exposure pathways; and to provide information needed to allow for the development of an accurate, science based assessment of risks. DuPont stated that there have been no known adverse human health effects associated with PFOA in the more than 50 years of PFOA use by DuPont and others.

° The Telomer Research Program ( TRP) noted that questions have been raised about the potential for telomer products to transform to PFOA. TRP stated that it is actively working to identify the relevant routes by which telomer products may transform to PFOA and, if they do, to what degree these transformations take place and if there may be human or environmental exposure of consequence. TRP urged EPA to take a comprehensive and holistic approach to understanding environmental and human exposure to develop a risk assessment on PFOA and its salts that would include PFOA manufacture and use, the potential contribution by discontinued PFOS based products, and telomers.

° The Fluoropolymer Manufacturers Group ( FMG) of the Society of the Plastics Industry ( SPI) stated that it is committed to working with the EPA to define the routes of exposure to the public and the environment; to characterize the health implications of that exposure; and to significantly reduce the potential exposure sources from the fluoropolymer industry. FMG also noted that fluoropolymers have many important uses in a wide variety of vital industries, and that PFOA is an indispensable polymerization aid in the manufacture of those products.

Discussion EPA provided a brief overview of the Preliminary Framework document that was circulated to interested parties and placed in the docket on May 21, 2003 ( OPPT 2003 0012 U. S. Environmental Protection Agency June 16, 2003 3 0056). In the discussions that followed, agreement in principle was reached on most of the EPA data needs described in the Preliminary Framework, and it was agreed that further discussion of these data needs should occur in three technical workgroups. The technical workgroups were tasked to work out the technical details of testing and/ or reporting programs for the agreed upon data needs that can be developed into ECAs. The initial task set for each workgroup was to receive a detailed briefing from industry on the specifics of the commitments covered by the industry Letters of Intent ( LOIs), and to determine what details beyond the terms of the LOIs should be negotiated through the workgroups as part of the ECA process. A fourth workgroup was tasked to develop a roadmap for addressing confidential business information ( CBI) and proprietary information within the ECA discussions for PFOA and the telomers, as it relates to market information ( data need number 1 in Tables I and II of the EPA Preliminary Framework), test substances, and article identity. Draft ECA products from the workgroups will be brought back to the Plenary Group for discussion and concurrence.

The four technical workgroups and their participants and focus are:

° Confidential Business Information ( CBI) Workgroup Participants: EPA, the Consumer Product Safety Commission ( CPSC), 3M, the Environmental Working Group ( EWG), the Fluoropolymer Manufacturers Group ( FMG), the Telomer Research Program ( TRP), and the Tuppers Plains Chester Water District.

Objective: Develop a roadmap to meaningfully communicate, within the PFOA ECA process, information regarding marketing data, test substance( s), and article identity in a way that preserves proprietary information and satisfies the needs of EPA and the interested parties.

° Environmental Monitoring Workgroup Participants : EPA, 3M, EWG, FMG, TRP, the Little Hocking Water Association, environmental consultants Bennett & Williams, the WV Class Action Plaintiffs group, the National Center for Policy Research for Women and Families, consulting toxicologist Rich Purdy, and the Tuppers Plains Chester Water District.

Objective: To develop ECA proposal( s) for screening level environmental monitoring of PFOA and PFOA precursors as identified by the Plenary Group. The initial focus will be for data needs identified in item 10 of Table I and item 10 of Table II of the EPA Preliminary Framework document, specifically addressing environmental sampling and monitoring in the vicinity of telomer and fluoropolymer manufacturing and use facilities. The interested parties were U. S. Environmental Protection Agency June 16, 2003 4 supportive of using the existing 3M and DuPont analytical protocols and sampling methods as a starting place to develop analytical protocols and sampling methods specifically addressing PFOA data needs under the ECA. In addition, the Workgroup will develop considerations for site selection in monitoring studies.

° Fluoropolymer Workgroup Participants: EPA, CPSC, 3M, FMG, EWG, and Bennett & Williams.

Objective: To develop ECA proposal( s) for data needs identified in items 2, 7, 8, 9 and 11 of Table II in the EPA Preliminary Framework document, specifically addressing: ( a) the physical/ chemical ( p chem) properties of the fluoropolymers; ( b) the presence of PFOA emitted from fluoropolymer treated products and articles as they age during use for those products and articles not included in the LOI commitments; ( c) determining the incineration byproducts of fluoropolymers and fluoropolymer treated articles and determining the p chem, fate, and transport properties of those byproducts; and ( d) product stewardship information.

° Telomer Workgroup Participants: EPA, CPSC, 3M, EWG, TRP, and Rich Purdy.

Objective: To develop ECA proposal( s) for telomers and telomer treated products as identified by the Plenary Group. The initial focus will be for the data needs identified in items 2, 3, 4, 5, 6, 7, 8, 9, and 12 of Table I of the Preliminary Framework document prepared by EPA, specifically addressing: ( a) P chem properties to inform fate testing for telomer chemicals not included in the industry sponsored LOI; ( b) elucidation of degradation pathways and identification of degradation products; ( c) determination of p chem, fate and transport properties of major degradation products; ( d) determination of incineration byproducts of telomers and telomer treated products and articles; ( e) determination of p chem, fate and transport properties of major incineration byproducts; ( f) presence/ quantification of PFOA precursors in telomer chemical products and in telomer treated or telomer containing products and articles; ( g) presence of PFOA precursors emitted from telomer treated products and articles as they age during use; and ( h) product stewardship information.

Agreement in principle was not reached on several data needs identified in the EPA Preliminary Framework, and these will receive additional discussion in the Plenary. These include the need for data assessing the potential biodegradation products and pathways of fluoropolymers, and conducting a release and exposure assessment for PFOA and PFOA precursors from telomer based fire fighting foams. With respect to the first set of issues, the U. S. Environmental Protection Agency June 16, 2003 5 FMG indicated that fluoropolymers are not expected to biodegrade. The Fire Fighting Foam Coalition ( FFFC) indicated that it is in the process of collecting information concerning fire fighting foam releases, principally from sites managed by the Department of Defense, and will submit that information to the Agency as it becomes available. These data needs will be the subject of further discussions at the July plenary session.

Summary of Public Comments One private citizen and one organization made oral statements during the public comment portion of the meeting. Della Tennant, a West Virginia resident owning property close to the DuPont Dry Run landfill and a plaintiff in an earlier lawsuit against DuPont, spoke about her own experiences and described health problems recounted to her by other members of the community. She asked EPA to take action to resolve the PFOA water contamination issues. Diana Zuckerman of the National Center for Policy Research for Women and Families encouraged EPA to look for patterns in the problems that people were reporting and to make certain that the ECA process would balance all customer needs and apply scrutiny to all sides of the issues. The Center, which had not previously registered as an interested party, expressed the desire to participate on the Monitoring Workgroup, and was accorded interested party status.

EPA indicated that anyone who wished to augment an opening statement or other comments could submit their additional materials to the docket within ten days of the meeting, preferably through direct electronic submission to the online docket.

Next Steps EPA noted that the urgency of the PFOA ECA process to develop PFOA source and environmental fate and exposure pathway data will require a tight schedule for follow up meetings. EPA pledged to make every effort to keep the interested parties informed through meeting summaries submitted to the electronic docket for this action, and by scheduling meetings with an eye to reducing travel and making teleconferencing available whenever possible. The Plenary Group developed a schedule for the next meetings under the ECA process.

Initial Technical Workgroup meetings will be scheduled at EPA Headquarters in Washington, DC during the weeks of June 16 or June 23, 2003. Teleconference facilities will be available for those who cannot attend the meeting in person. The workgroups will have another opportunity to meet in person in Washington, DC on Wednesday, July 9, 2003. The next plenary session will be held on Thursday, July 10, 2003. Topics to be discussed at the July Plenary session will include: ( 1) reports from the Workgroups; ( 2) data needs identified in the EPA Preliminary Framework document which were not tasked to the Workgroups at the June meeting; and ( 3) other topics as appropriate. Additional workgroup meetings and another plenary session are tentatively scheduled for September, 2003.


[Federal Register Volume 75, Number 44 (Monday, March 8, 2010)]
[Notices]
[Page 10550]
[FR Doc No: 2010-4848]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent to Request Revision From the Office of
Management and Budget of a Currently Approved Information Collection
Activity, Request for Comments; Washington, DC Metropolitan Area
Special Flight Rules

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: The FAA invites public comments about our intention to request
the Office of Management and Budget (OMB) to approve a current
information collection. This information collection is required for
compliance with the final rule that codifies special flight rules and
airspace and flight restrictions for certain operations in the
Washington, DC Metropolitan Area. OMB has granted this collection a
six-month clearance expiring in August, 2010, in order for FAA to
provide clarifying details about the collection methods; this notice is
to correspond with an immediate resubmission to OMB for full three-year
clearance.

DATES: Please submit comments by May 7, 2010.

FOR FURTHER INFORMATION CONTACT: Carla Mauney on<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Federal Aviation Administration (FAA)

    Title: Washington, DC Metropolitan Area Special Flight Rules.
    Type of Request: Extension without change of an approved
collection.
    OMB Control Number: 2120-0706.
    Forms(s): There are no FAA forms associated with this collection.
    Affected Public: A total of 17,097 Respondents.
    Frequency: The information is collected on occasion.
    Estimated Average Burden per Response: Approximately 2.9 hours per
response.
    Estimated Annual Burden Hours: An estimated 49,223 hours annually.
    Abstract: This information collection is required for compliance
with the final rule that codifies special flight rules and airspace and
flight restrictions for certain operations in the Washington, DC
Metropolitan Area.

ADDRESSES: Send comments to the FAA at the following address: Ms. Carla
Mauney, Room 712, Federal Aviation Administration, IT Enterprises
Business Services Division, AES-200, 800 Independence Ave., SW.,
Washington, DC 20591.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimates of the burden of
the proposed information collection; ways to enhance the quality,
utility and clarity of the information to be collected; and ways to
minimize the burden of the collection of information on respondents,
including the use of automated collection techniques or other forms of
information technology.

    Issued in Washington, DC, on March 2, 2010.
Carla Mauney,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. 2010-4848 Filed 3-5-10; 8:45 am]
BILLING CODE 4910-13-P