zeranol is 1.25 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerances for zeranol are:
    (1) Cattle. Edible tissues (excluding milk): Not required.
    (2) Sheep. Edible tissues (excluding milk): 20 ppb.
    (c) Related conditions of use. See Sec.  522.2680 of this chapter.

Sec.  556.765  Zilpaterol.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
zilpaterol is 0.083 [mu]g/kg of body weight per day.
    (b) Tolerances. The tolerance for zilpaterol freebase (marker
residue) is:
    (1) Cattle. Liver (target tissue): 12 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  558.665 of this chapter.

Sec.  556.770  Zoalene.

    (a) [Reserved]
    (b) Tolerances. The tolerances for zoalene and its metabolite 3-
amino-5-nitro-o-toluamide are:
    (1) Chickens. (i) Liver and kidney: 6 ppm.
    (ii) Muscle: 3 ppm.
    (iii) Fat: 2 ppm.
    (2) Turkeys. Liver and muscle: 3 ppm.
    (c) Related conditions of use. See Sec.  558.680 of this chapter.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
32. The authority citation for part 558 continues to read as follows:

    Authority:  21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

Sec.  558.68  [Amended]

0
33. In Sec.  558.68, in paragraph (c), remove ``556.68'' and in its
place add ``556.60''.

0
34. In Sec.  558.95, add paragraph (c) to read as follows:

Sec.  558.95  Bambermycins.

* * * * *
    (c) Related tolerances. See Sec.  556.75 of this chapter.
* * * * *

0
35. In Sec.  558.185, revise paragraph (c) to read as follows:

Sec.  558.185  Coumaphos.

* * * * *
    (c) Related tolerances. See Sec.  556.168 of this chapter.
* * * * *

0
36. In Sec.  558.235, revise paragraph (a), redesignate paragraph (b)
as paragraph (d), and add new paragraphs (b) and (c) to read as
follows:

Sec.  558.235  Efrotomycin.

    (a) Specifications. Type A medicated articles containing 14.5 grams
efrotomycin per pound.
    (b) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.224 of this chapter.
* * * * *

0
37. In Sec.  558.464, revise paragraph (a), redesignate paragraph (b)
as paragraph (d), and add new paragraphs (b) and (c) to read as
follows:

Sec.  558.464  Poloxalene.

    (a) Specifications. Dry Type A medicated articles containing 53
percent poloxalene or liquid Type A medicated articles containing 99.5
percent poloxalene.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.517 of this chapter.
* * * * *

0
38. In Sec.  558.465, revise paragraph (a), redesignate paragraph (b)
as paragraph (d), and add new paragraphs (b) and (c) to read as
follows:

Sec.  558.465  Poloxalene free-choice liquid Type C feed.

    (a) Specifications. Type A medicated articles containing 99.5
percent poloxalene.
    (b) Sponsor. See No. 066104 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.517 of this chapter.
* * * * *

Sec.  558.625  [Amended]

0
39. In Sec.  558.625, in paragraph (c), remove ``556.740'' and in its
place add ``556.746''.

Sec.  558.630  [Amended]

0
40. In Sec.  558.630, in paragraph (c), remove ``556.740'' and in its
place add ``556.746''.

    Dated: June 20, 2019.
Norman E. Sharpless,
Acting Commissioner of Food and Drugs.

    Dated: June 25, 2019.
Eric D. Hargan,
Deputy Secretary, Department of Health and Human Services.
[FR Doc. 2019-14098 Filed 7-10-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: December 7, 2005 (Volume 70, Number 234)]
[Notices]
[Page 72814]
[DOCID:fr07de05-62]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 459-143, Docket No. EL05-73-003]

Duncan's Point Lot Owners Association, Inc.; Duncan's Point
Homeowners Association, Inc.; and Nancy A. Brunson, Juanita Brackens,
Helen Davis, and Pearl Hankins, Individually v. Union Electric Company
d/b/a AmerenUE; Notice Dismissing Complaint as Premature

November 28, 2005.
    On November 14, 2005, Duncan's Point Lot Owners Association, Inc.,
Duncan's Point Homeowners Association, Inc., Nancy A. Brunson, Juanita
Brackens, Helen Davis, and Pearl Hankins (Complainants) filed what they
termed a formal complaint against Union Electric Company, doing
business as AmerenUE, licensee of the Osage Hydroelectric Project No.
459. The project is located on the Lake of the Ozarks in Missouri.
Complainants allege that the licensee has failed or refused to comply
with the Commission staff's letter order of September 7, 2004, and the
Commission's order of May 9, 2005 (111 FERC ] 61,190). In support, they
raise issues concerning the licensee's compliance filing of October 14,
2005, and Commission staff's site visit report of July 29, 2005.
    On September 15, 2005, the Commission denied Complainants' request
for rehearing of the Commission's May 9 order. See 112 FERC ] 61,289.
Therefore, the issues resolved in that decision are final and may not
be the subject of a new complaint. On September 1, 2005, Commission
staff issued a letter order concerning some outstanding compliance
issues concerning the project. On September 30, 2005, Complainants
filed a request for rehearing of staff's September 1 letter order.
    The issues raised in Complainants filing of November 14, 2005,
either relate to an ongoing compliance proceeding for which Commission
staff has not yet completed its determinations, or are the subject of
Complainants' request for rehearing of staff's letter order of
September 1, 2005.\1\ As such, they are not yet final and are not
properly the subject of a formal complaint. Accordingly, the complaint
is dismissed as premature. Complainants will have an opportunity to
seek further relief after the pending staff and Commission actions have
been completed.
---------------------------------------------------------------------------

    \1\ To the extent that Complainants seek to raise issues
regarding the conduct of the Commission or its staff, these matters
are outside the scope of the Commission's complaint process. See 18
CFR 385.206(a).

Magalie R. Salas,
Secretary.
 [FR Doc. E5-6933 Filed 12-6-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 141 (Friday, July 22, 2011)]
[Notices]
[Pages 44014-44015]
[FR Doc No: 2011-18591]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0381]

Generic Drug User Fee; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

    The Food and Drug Administration (FDA) is announcing a public
meeting to provide a public update and to gather additional stakeholder
input on the development of a generic drug user fee program. A user fee
program could provide necessary supplemental funding, in addition to
current Congressional appropriations, to facilitate the timely review
of human generic drug applications by FDA. FDA has been in negotiations
with the regulated industry aimed at providing a consensus proposal for
Congressional consideration. In the interest of transparency, and to
assure that all interested stakeholders' views are heard and
considered, whether they are present at the negotiations or not, FDA is
holding a fourth public meeting on this topic to provide an update and
to gather additional input on such a program.
    Date and Time: The public meeting will be held on August 25, 2011,
from 2 to 3:30 p.m.
    Location: The public meeting will be held at FDA's White Oak
Campus, 10903 New Hampshire Ave., Bldg. 1, Conference Rooms 4101, 4103,
and 4105, Silver Spring, MD 20993-0002.
    Contact Person: Mari Long, Office of Policy, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4237, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>, FAX<PHONE_NUMBER>,
<EMAIL_ADDRESS>or
    Peter C. Beckerman, Office of Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, rm. 4238, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>, FAX<PHONE_NUMBER><EMAIL_ADDRESS>    Registration and Requests for Oral Presentations: If you wish to
attend and/or present at the meeting, please e-mail your registration
information to<EMAIL_ADDRESS>by August 18, 2011. Your e-
mail should contain complete contact information for each attendee,
including name, title, affiliation, address, e-mail address, and
telephone number. Registration is free and will be on a first-come,
first-served basis. Early registration is recommended because seating
is limited. FDA may limit the number of participants from each
organization as well as the total number of participants, based on
space limitations. Registrants will receive confirmation once they have
been accepted. Onsite registration on the day of the meeting will be
based on space availability. We will try to accommodate all persons who
wish to make a presentation. The time allotted for presentations may
depend on the number of persons who wish to speak, and if the entire
meeting time is not needed for presentations, FDA reserves the right to
terminate the meeting early.
    If you need special accommodations because of disability, please
contact Mari Long or Peter Beckerman (see Contact Person) at least 7
days before the meeting.
    Comments: Regardless of attendance at the public meeting,
interested persons may submit either electronic or written comments
regarding this document. To ensure consideration, all comments must be
received by September 26, 2011. Submission of comments prior to the
meeting is strongly encouraged. Submit any comments that you plan to
present at the public meeting to the docket by the date of the public
meeting, but note that either electronic or written comments generally
may be submitted until September 26, 2011.
    Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing its intention to hold a public meeting related to
generic drug user fees. New legislation would be required for FDA to
establish and collect user fees for generic drugs, and FDA has been
engaged in negotiations with industry over aspects of a joint proposal
for a generic drug user fee program, including fees and performance
goals, for several months. The Agency has held three prior public
meetings on the topic before and during this process. Because FDA can
only negotiate with trade organizations, not individual companies, but
remains interested in hearing from non-affiliated companies in addition
to patient and consumer stakeholders, the Agency is holding an
additional public meeting. The meeting will provide a status update and
seek input from stakeholders on generic drug user fees. In addition,
FDA continues to encourage all interested stakeholders to submit either
electronic or written comments to the docket (see Comments).

II. What information should you know about the public meeting, when and
where will the public meeting occur, and what format will FDA use?

    Through this notice, we are announcing a public meeting to update
stakeholders and hear stakeholder views on what features FDA should
propose for a generic drug user fee program. We will conduct the
meeting on August 25, 2011, from 2 to 3:30 p.m. at FDA's White Oak
Campus, 10903 New Hampshire Ave., Bldg. 1, Conference Rooms 4101, 4103,
and 4105, Silver Spring, MD 20993-0002. In general, the

meeting format will include a presentation by FDA and presentations by
stakeholders and members of the public who have registered in advance
to present at the meeting. The amount of time available for
presentations will be determined by the number of people who register
to make a presentation. We will also provide an opportunity for
organizations and individuals to submit either electronic or written
comments to the docket after the meeting (see Comments). FDA policy
issues are beyond the scope of this initiative. Accordingly, the
presentations should focus on process and funding issues, and not focus
on policy.

    Dated: July 19, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-18591 Filed 7-21-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: July 12, 2010 (Volume 75, Number 132)]
[Notices]
[Page 39699-39700]
[DOCID:fr12jy10-60]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-F-0069] (formerly Docket No. 2004F-0455)

Sterigenics International, Inc.; Withdrawal of Food Additive
Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
withdrawal, without prejudice to a future filing, of a food additive
petition (FAP 3M4744) proposing that the food additive regulations be
amended to provide for the safe use of ionizing radiation in the
production of shelf stable foods, including multiple ingredient shelf
stable foods.

FOR FURTHER INFORMATION CONTACT: Lane A. Highbarger, Center for Food
Safety and Applied Nutrition (HFS-255), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of November 30, 2004 (69 FR 69606), FDA announced that a food
additive petition (FAP 3M4744) had been filed by Sterigenics
International, Inc., P.O. Box 17349, Memphis, TN 31817-0349 (current
address 2015 Spring Rd., suite 650, Oak Brook, IL 60523). The petition
proposed to amend the food additive regulations in 21 CFR part 179
Irradiation in the Production, Processing and Handling of Food to
provide for the

safe use of ionizing radiation in the production of fully cooked shelf
stable foods, including fully cooked multiple ingredient shelf stable
foods, where the absorbed dose required to cause a 12-log reduction in
Clostridium botulinum has been established. Sterigenics International,
Inc., has now withdrawn the petition without prejudice to a future
filing (21 CFR 171.7).

    Dated: June 30, 2010.
Mitchell A. Cheeseman,
Acting Director, Office of Food Additive Safety, Center for Food Safety
and Applied Nutrition.
[FR Doc. 2010-16884 Filed 7-12-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 76, Number 98 (Friday, May 20, 2011)]
[Notices]
[Page 29287]
[FR Doc No: 2011-12476]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Office of
Dispute Resolution Procedures for Protests and Contact Disputes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval for to renew an information
collection. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on March 10, 2011, vol. 76, no. 47, page 13264-13265. 14 CFR
part 17 sets forth procedures for filing solicitation protests and
contract claims in the FAA's Office of Dispute Resolution for
Acquisition. The regulations seek factual and legal information from
protesters or claimants primarily through written submissions.

DATES: Written comments should be submitted by June 20, 2011.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, Docket Library, Room 10102, 725 17th Street, NW., Washington,
DC 20503.

FOR FURTHER INFORMATION CONTACT: Carla Scott on<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0632.
    Title: Office of Dispute Resolution Procedures for Protests and
Contact Disputes.
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Renewal of an information collection.
    Background: 14 CFR 17.15 and 17.25 provide the procedures for
filing protests and contract claims with the Office of Dispute
Resolution for Acquisition. The regulations seek factual and legal
information from protesters or claimants primarily through written
submissions. The information sought by the regulations is used by the
ODRA, as well as the opposing parties: (1) To gain a clear
understanding as to the facts and the law underlying the dispute; and
(2) to provide a basis for applying dispute resolution techniques.
    Respondents: Approximately 45 protestors or claimants.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 20.5 hours.
    Estimated Total Annual Burden: 923 hours.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC, on May 16, 2011.
Carla Scott,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. 2011-12476 Filed 5-19-11; 8:45 am]
BILLING CODE 4910-13-P