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Federal Register / Vol. 71, No.

28 / Friday, February 10, 2006 / Notices 7053

of the factual and legal grounds on person may request, in accordance with relevant to the request. Respondents to
which the interested person relies in § 10.20 (submission of documents to the this collection of information are
seeking the stay. FDA uses the DDM), an advisory opinion from the interested persons seeking an advisory
information provided in the request to Commissioner on a matter of general opinion from the Commissioner on the
determine whether to grant the petition applicability. An advisory opinion agency’s formal position for matters of
for a stay of action. Respondents to this represents the formal position of FDA general applicability.
information collection are interested on a matter of general applicability.
When making a request, the petitioner In the Federal Register of November
persons who choose to file a petition for
an administrative stay of action. must provide a concise statement of the 16, 2005 (70 FR 69574), FDA published
Section 10.85, issued under section issues and questions on which an a 60-day notice requesting public
701(a) of the act, sets forth the format opinion is requested, and a full comment on the information collection
and procedures by which an interested statement of the facts and legal points provisions. No comments were received.

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1


21 CFR Annual Frequency per Re-
No. of Respondents Total Annual Responses Hours per Response Total Hours
Section sponse

10.30 156 3 468 12 5,616


10.33 10 2 20 10 200
10.35 13 2 26 10 260
10.85 2 1 2 16 32
Total 6,108
1There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: February 6, 2006. Restoration Act of 1984 (Public Law 98– to help diagnose problems or diseases of
Jeffrey Shuren, 417) (the 1984 amendments), which the stomach. This test determines how
Assistant Commissioner for Policy. authorized the approval of duplicate much acid a patient’s stomach
[FR Doc. E6–1846 Filed 2–9–06; 8:45 am] versions of drug products approved produces.
BILLING CODE 4160–01–S
under an ANDA procedure. ANDA PEPTAVLON for subcutaneous
sponsors must, with certain exceptions, injection, 0.25 mg/mL, was approved on
show that the drug for which they are July 26, 1974. Wyeth Ayerst ceased
DEPARTMENT OF HEALTH AND seeking approval contains the same manufacture of PEPTAVLON for
HUMAN SERVICES active ingredient in the same strength subcutaneous injection, 0.25 mg/mL, in
and dosage form as the ‘‘listed drug,’’ March 2002, and requested that FDA
Food and Drug Administration which is typically a version of the drug withdraw approval of the NDA (68 FR
[Docket No. 2005P–0104] that was previously approved. Sponsors 49481, August 18, 2003). Therefore, it
of ANDAs do not have to repeat the was moved from the ‘‘Prescription Drug
Determination That PEPTAVLON extensive clinical testing otherwise Product List’’ to the ‘‘Discontinued Drug
(Pentagastrin) for Subcutaneous necessary to gain approval of a new Product List’’ section of the Orange
Injection, 0.25 Milligrams per Milliliter, drug application (NDA). The only Book. The ‘‘Discontinued Drug Product
Was Not Withdrawn From Sale for clinical data required in an ANDA are List’’ delineates, among other items,
Reasons of Safety or Effectiveness data to show that the drug that is the drug products that have been
subject of the ANDA is bioequivalent to discontinued from marketing for reasons
AGENCY: Food and Drug Administration, the listed drug. other than safety or effectiveness.
HHS. The 1984 amendments include what Under 21 CFR 314.161(a)(3), the
ACTION: Notice. is now section 505(j)(7) of the Federal agency must determine whether a listed
Food, Drug, and Cosmetic Act (21 U.S.C. drug was withdrawn from sale for
SUMMARY: The Food and Drug
355(j)(7)), which requires FDA to reasons of safety or effectiveness when
Administration (FDA) has determined
publish a list of all approved drugs. a person petitions for such a
that PEPTAVLON (pentagastrin) for
FDA publishes this list as part of the determination under 21 CFR 10.25(a)
subcutaneous injection, 0.25 milligrams
‘‘Approved Drug Products With and § 10.30 (21 CFR 10.30).
(mg) per milliliter (mL), was not
Therapeutic Equivalence Evaluations,’’ Arnall Golden Gregory LLP submitted
withdrawn from sale for reasons of
which is generally known as the a citizen petition dated March 7, 2005
safety or effectiveness. This
‘‘Orange Book.’’ Under FDA regulations, (Docket No. 2005P–0104/CP1), under
determination will allow FDA to
drugs are withdrawn from the list if the § 10.30, requesting that the agency
approve abbreviated new drug
agency withdraws or suspends approval determine whether PEPTAVLON
applications (ANDAs) for pentagastrin
of the drug’s NDA or ANDA for reasons (pentagastrin) for subcutaneous
for subcutaneous injection, 0.25 mg/mL.
of safety or effectiveness, or if FDA injection, 0.25 mg/mL, was withdrawn
FOR FURTHER INFORMATION CONTACT: determines that the listed drug was from sale for reasons of safety or
Tawni B. Schwemer, Center for Drug withdrawn from sale for reasons of effectiveness. After considering the
Evaluation and Research (HFD–7), Food safety or effectiveness (21 CFR 314.162). citizen petition and reviewing agency
and Drug Administration, 5600 Fishers
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PEPTAVLON for subcutaneous records, FDA has determined that


Lane, Rockville, MD 20857,301–594– injection is the subject of approved NDA PEPTAVLON for subcutaneous
2041. 17–048 held by Wyeth Ayerst injection, 0.25 mg/mL, approved under
SUPPLEMENTARY INFORMATION: In 1984, Laboratories (Wyeth Ayerst). NDA 17–048, was not withdrawn from
Congress enacted the Drug Price PEPTAVLON (pentagastrin) for sale for reasons of safety or
Competition and Patent Term subcutaneous injection is a testing agent effectiveness. The petitioner identified

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7054 Federal Register / Vol. 71, No. 28 / Friday, February 10, 2006 / Notices

no data or other information suggesting Convention Center, 2010 5th Avenue Procedural
that PEPTAVLON (pentagastrin) for North, Texas City, Texas 77590, (409– Working groups have been formed to
subcutaneous injection, 0.25 mg/mL, 948–3111). The working groups meeting examine the following issues: Dredging
was withdrawn from sale as a result of will be held at Coast Guard Sector and related issues, electronic navigation
safety or effectiveness concerns. FDA’s Houston-Galveston, 9640 Clinton Dr. systems, AtoN knockdowns, impact of
independent evaluation of relevant Houston, TX 77029 (713–671–5100). passing vessels on moored ships, boater
literature and data has not uncovered This notice is available on the Internet education issues, facilitating deep draft
anything that would indicate that this at http://dms.dot.gov. movements and mooring infrastructure.
product was withdrawn for reasons of FOR FURTHER INFORMATION CONTACT: Not all working groups will provide a
safety or effectiveness. Accordingly, the Captain Richard Kaser, Executive report at this session. Further, working
agency will continue to list Director of HOGANSAC, telephone group reports may not necessarily
PEPTAVLON (pentagastrin) for (713) 671–5199, Commander Jerry include discussions on all issues within
subcutaneous injection, 0.25 mg/mL, in Torok, Executive Secretary of the particular working group’s area of
the ‘‘Discontinued Drug Product List’’ HOGANSAC, telephone (713) 671–5164, responsibility. All meetings are open to
section of the Orange Book. ANDAs that or Lieutenant Junior Grade Kevin the public. Please note that the meetings
refer to PEPTAVLON for subcutaneous Cooper, Assistant to the Executive may adjourn early if all business is
injection, 0.25 mg/mL, may be approved Secretary of HOGANSAC, telephone finished. Members of the public may
by the agency. (713) 678–9001, e-mail make presentations, oral or written, at
Dated: February 2, 2006. kcooper@grugalveston.uscg.mil. Written either meeting. Requests to make oral
Jeffrey Shuren, materials and requests to make presentations or distribute written
Assistant Commissioner for Policy. presentations should be sent to materials at the full HOGANSAC
[FR Doc. E6–1847 Filed 2–9–06; 8:45 am] Commanding Officer, Sector Houston/ meeting should reach the Coast Guard
BILLING CODE 4160–01–S
Galveston, Attn: LTJG Cooper, 9640 five (5) working days before that
Clinton Drive, Houston, TX 77029. meeting. Requests to have written
SUPPLEMENTARY INFORMATION: Notice of materials distributed to each member of
DEPARTMENT OF HOMELAND this meeting is given pursuant to the the full committee in advance of their
SECURITY Federal Advisory Committee Act, 5 meeting should reach the Coast Guard at
U.S.C. App. 2. least ten (10) working days before the
Coast Guard full HOGANSAC meeting and should
Agendas of the Meetings include fifteen (15) copies of the
[CGD08–06–003]
Houston/Galveston Navigation Safety materials.
Houston/Galveston Navigation Safety Advisory Committee (HOGANSAC). The Information on Services for the
Advisory Committee tentative agenda includes the following: Handicapped
(1) Opening remarks by the
AGENCY: Coast Guard, DHS. Committee Sponsor (RADM Duncan) or For information on facilities or
ACTION: Notice of meetings. the Committee Sponsor’s representative, services for the handicapped or to
Executive Director (CAPT Kaser) and request special assistance at the
SUMMARY: The Houston/Galveston meetings, contact the Executive
Chairperson (Ms. Patricia Clark).
Navigation Safety Advisory Committee Director, Executive Secretary, or
(HOGANSAC) and its working groups (2) Approval of the October 18, 2005
minutes. Assistant to the Executive Secretary as
will meet to discuss waterway soon as possible.
improvements, aids to navigation, area (3) Old Business:
projects impacting safety on the (a) Dredging projects. Dated: January 27, 2006.
Houston Ship Channel, and various (b) AtoN Knockdown Working Group. R.F. Duncan,
other navigation safety matters in the (c) Navigation Operations Rear Admiral, U.S. Coast Guard, Commander,
Galveston Bay area. All meetings will be subcommittee report. Eighth Coast Guard District.
open to the public. (d) Area Maritime Security Committee [FR Doc. 06–1276 Filed 2–7–06; 3:58 pm]
DATES: The next meeting of HOGANSAC Liaison’s report. BILLING CODE 4910–15–P

will be held on Thursday, February 23, (e) Technology subcommittee report.


2006 at 1 p.m. The meeting of the (f) Deep draft Entry Facilitation
Committee’s working groups will be Working Group. DEPARTMENT OF HOMELAND
held on Thursday, February 9, 2006 at (g) Port Coordination Team Updates. SECURITY
9 a.m. The meetings may adjourn early (h) Limited Visibility Working Group.
(i) Liquified Natural Gas Working Coast Guard
if all business is finished. Members of
the public may present written or oral Group. [USCG–2006–23862]
statements at either meeting. Requests to (4) New Business.
make oral presentations or distribute (a) Vessel Traffic Service State of the Maritime Security Directive (MARSEC
written materials at the full Waterways Address. Directive) 104–6; Guidelines for U.S.
HOGANSAC meeting should reach the (b) Swearing in of new member. Vessels Operating in High Risk Waters
Coast Guard five (5) working days before (c) Other presentations/New business. AGENCY: Coast Guard, DHS.
that meeting. Requests to have written Working Groups Meeting. The ACTION: Notice of availability.
materials distributed to each member of tentative agenda for the working groups
the full committee in advance of their
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meeting includes the following: SUMMARY: The Coast Guard announces


meeting should reach the Coast Guard at (1) Presentation by each working the availability of MARSEC Directive
least ten (10) working days before the group of its accomplishments and plans 104–06. This MARSEC Directive
full HOGANSAC meeting. for the future. provides guidelines for U.S. vessels
ADDRESSES: The full Committee meeting (2) Review and discuss the work operating in high risk waters.
will be held at the Charles P. Doyle completed by each working group. Information within this MARSEC

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