"Beverly Kerr"<EMAIL_ADDRESS>                               05/01/2008 04:26 PM

Please respond to

<EMAIL_ADDRESS>

To

Cathy Milbourn/DC/USEPA/US@EPA

cc

Subject

EPA Proposes Stronger Air Quality Standards for Lead

Dear Cathy,

We are delighted to know that stronger air quality standards are being considered.  We operate a child care center that is located beside a galvanizing plant.  We have been concerned for years about their pollution.  We would like to be kept informed of any information on this subject.  We would like to make written comments for the public hearing.  Please keep us informed and send us any links of interest.

God bless you for the important work you are doing.  You are much appreciated.  Thank you.

Beverly and Julius Kerr

Be Safe Not Sorry Community Action Group

Alamance County, North Carolina Chapter of

Blue Ridge Environmental Defense League

Visit BREDL website: http://bredl.org

A Storybook Farm Christian School

(Before and After School and Summer Camp)

Visit Storybook website: http://beverlykerr.tripod.com

AVON Center

(Buy, Sell, Shop, Work from Home! )

Visit AVON website: http://youravon.com/beverlykerr

Visit us at 4772 Hwy 54, Graham, NC 27253

Email us at<EMAIL_ADDRESS> Call us at<PHONE_NUMBER>

Alison Davis/RTP/USEPA/US

05/01/2008 04:44 PM

To

<EMAIL_ADDRESS> cc

Subject

EPA Proposes Stronger Air Quality Standards for Lead

Dear Ms Kerr:

Cathy Milbourn passed along your note and asked me to send you information on how to comment on the proposed stronger lead standards.

EPA will take comment for 60 days after this rule is published in the Federal Register. There are a number of ways you can submit comments. They're listed on page 6 of this fact sheet:

http://www.epa.gov/air/lead/pdfs/20080501_factsheet.pdf

Additional information, including the text of the proposed standards, is available at www.epa.gov/air/lead

Please don't hesitate to contact me if you have additional questions.

___________________________________________

Alison Davis

Senior Advisor for Public Affairs

U.S. EPA, Office of Air Quality Planning & Standards

109 T.W. Alexander Drive

Durham, NC 27711

tel.<PHONE_NUMBER>


[Federal Register Volume 86, Number 224 (Wednesday, November 24, 2021)]
[Notices]
[Pages 67065-67067]
[FR Doc No: 2021-25612]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-E-2122]

Determination of Regulatory Review Period for Purposes of Patent
Extension; TRODELVY

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for TRODELVY and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human
biological product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by January 24, 2022.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by May 23, 2022. See ``Petitions''
in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 24, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 24, 2022. Comments
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 comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-E-2122 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; TRODELVY.'' Received comments, 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, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological product. Although only a portion of a regulatory review
period may count toward the actual amount of extension that the
Director of USPTO may award (for example, half the testing phase must
be subtracted as well as any time that may have occurred before the
patent was issued), FDA's determination of the length of a regulatory
review period for a human biological product will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(1)(B).
    FDA has approved for marketing the human biologic product TRODELVY
(sacituzumab govitecan-hziy). TRODELVY is indicated for the treatment
of adult patients with metastatic triple-negative breast cancer who
have received at least two prior therapies for metastatic disease. This
indication is approved under accelerated approval based on tumor
response rate and duration of response. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in confirmatory trials. Subsequent to this approval,
the USPTO received a patent term restoration application for TRODELVY
(U.S. Patent No. 7,999,083) from Immunomedics, Inc., and the USPTO
requested FDA's assistance in determining this patent's eligibility for
patent term restoration. In a letter dated January 4, 2021, FDA advised
the USPTO that this human biological product had undergone a regulatory
review period and that the approval of TRODELVY represented the first
permitted commercial marketing or use of the product. Thereafter, the
USPTO requested that FDA determine the product's regulatory review
period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
TRODELVY is 2,856 days. Of this time, 2,150 days occurred during the
testing phase of the regulatory review period, while 706 days occurred
during the

approval phase. These periods of time were derived from the following
dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: June 29,
2012. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on June 29,
2012.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): May 18, 2018. FDA has verified the
applicant's claim that the biologics license application (BLA) for
TRODELVY (BLA 761115) was initially submitted on May 18, 2018.
    3. The date the application was approved: April 22, 2020. FDA has
verified the applicant's claim that BLA 761115 was approved on April
22, 2020.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,780 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: November 15, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-25612 Filed 11-23-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: April 2, 2007 (Volume 72, Number 62)]
[Notices]
[Page 15673]
[DOCID:fr02ap07-35]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER07-491-000, and ER07-491-001]

Acacia Energy, Inc.; Notice of Issuance of Order

March 27, 2007.
    Acacia Energy, Inc. (Acacia Energy) filed an application for
market-based rate authority, with accompanying rate schedule. The
proposed market-based rate schedule provides for the sale of energy and
capacity at market-based rates. Acacia Energy also requested waivers of
various Commission regulations. In particular, Acacia Energy requested
that the Commission grant blanket approval under 18 CFR Part 34 of all
future issuances of securities and assumptions of liability by Acacia
Energy.
    On March 23, 2007, pursuant to delegated authority, the Director,
Division of Tariffs and Market Development--West, granted the requests
for blanket approval under Part 34. The Director's order also stated
that the Commission would publish a separate notice in the Federal
Register establishing a period of time for the filing of protests.
Accordingly, any person desiring to be heard or to protest the blanket
approvals of issuances of securities or assumptions of liability by
Acacia Energy should file a motion to intervene or protest with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure. 18 CFR 385.211, 385.214
(2004).
    Notice is hereby given that the deadline for filing motions to
intervene or protest is April 23, 2007.
    Absent a request to be heard in opposition by the deadline above,
Acacia Energy are authorized to issue securities and assume obligations
or liabilities as a guarantor, indorser, surety, or otherwise in
respect of any security of another person; provided that such issuance
or assumption is for some lawful object within the corporate purposes
of Acacia Energy, compatible with the public interest, and is
reasonably necessary or appropriate for such purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approvals of Acacia Energy's issuance of securities or
assumptions of liability.
    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also be viewed on the Commission's
Web site at http://www.ferc.gov, using the eLibrary link. Enter the

docket number excluding the last three digits in the docket number
filed to access the document. Comments, protests, and interventions may
be filed electronically via the internet in lieu of paper. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Philis J. Posey,
Acting Secretary.
 [FR Doc. E7-5992 Filed 3-30-07; 8:45 am]

BILLING CODE 6717-01-P