Federal Register / Vol. 78, No. 156 / Tuesday, August 13, 2013 / Notices
Leslie Kux,
20405–0001, telephone 202–501–4755. Assistant Commissioner for Policy. SUPPLEMENTARY INFORMATION:
[FR Doc. 2013–19523 Filed 8–12–13; 8:45 am] I. Background
Medical Foods; Second Edition.’’ This Casey Coleman,
draft guidance is being issued consistent Food and Drug Administration
[FR Doc. 2013–19633 Filed 8–12–13; 8:45 am] BILLING CODE 6820–34–P
[Docket No. FDA–2013–D–0880]
guidance, when finalized, will represent FDA’s current thinking on medical Draft Guidance for Industry on
Frequently Asked Questions About
rights for or on any person and does not DEPARTMENT OF HEALTH AND
Medical Foods; Second Edition;
AGENCY: Food and Drug Administration,
Food and Drug Administration
the applicable statutes and regulations. ACTION: Notice.
[Docket No. FDA–2012–N–0892]
SUMMARY: The Food and Drug
Agency Information Collection
Activities; Announcement of Office of
announcing the availability of the draft Management and Budget Approval;
Communicating Composite Scores in
Direct-to-Consumer Advertising
Medical Foods; Second Edition.’’ The II. Paperwork Reduction Act of 1995
AGENCY: Food and Drug Administration,
previously approved collections of information found in FDA regulations. ACTION: Notice.
labeling, and availability of medical foods and updates to some of the SUMMARY: The Food and Drug
DATES: Although you can comment on
that a collection of information entitled 10.115(g)(5)), to ensure that the Agency Direct-to-Consumer (DTC) Advertising’’ 101.3, 101.4, 101.5, 101.15, and 101.105 either electronic or written comments on the draft guidance by October 15, FOR FURTHER INFORMATION CONTACT:
Question 13 are not subject to review by ADDRESSES: Submit written requests for
Administration, 1350 Piccard Dr., PI50– ‘‘collection of information’’ under the is a ‘‘public disclosure of information SUPPLEMENTARY INFORMATION: On May
purpose of disclosure to the public’’ (5 adhesive labels to assist that office in III. Comments
electronic access to the draft guidance. electronic comments regarding this draft to, a collection of information unless it Dockets Management (see ADDRESSES). It
Management (HFA–305), Food and Drug comments. Identify comments with the FOR FURTHER INFORMATION CONTACT:
copy of the supporting statement for this Shawne Suggs-Anderson, Center for Federal Register / Vol. 78, No. 156 / Tuesday, August 13, 2013 / Notices
IV. Electronic Access
may obtain this draft guidance at either appropriate advisory committee meeting oral presentations should notify the information line to learn about possible Agenda: On September 19, 2013, and Leslie Kux,
or before August 22, 2013. Time allotted Assistant Commissioner for Policy. for each presentation may be limited. If [FR Doc. 2013–19532 Filed 8–12–13; 8:45 am] BILLING CODE 4160–01–P
Research Equity Act (Pub. L. 108–155). DEPARTMENT OF HEALTH AND
hearing session. The contact person will Food and Drug Administration
notify interested persons regarding their [Docket No. FDA–2013–N–0001]
Pediatric Advisory Committee; Notice
of Meeting
Chantix (varenicline tartrate); Isentress AGENCY: Food and Drug Administration,
ACTION: Notice.
General Function of the Committee: Date and Time: The meeting will be Location: Doubletree Hilton Hotel, material available to the public no later than 2 business days before the meeting. the Federal Advisory Committee Act (5 20910, 301–589–5200 or visit the hotel’s If FDA is unable to post the background Jill Hartzler Warner,
Acting Associate Commissioner for Special Contact Person: Walter Ellenberg, will be posted on FDA’s Web site after [FR Doc. 2013–19522 Filed 8–12–13; 8:45 am] BILLING CODE 4160–01–P
appropriate advisory committee meeting HUMAN SERVICES
Procedure: Interested persons may Food and Drug Administration
1–800–741–8138 (301–443–0572 in the [Docket No. FDA–2013–N–0001]
Federal Register about last minute
Circulatory System Devices Panel of
submissions may be made to the contact the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY: Food and Drug Administration,
ACTION: Notice.


Microsoft word - leukocel_package_insert.doc

LEUKOCEL Hydroxyurea capsules, USP 500 mg Each capsule contains Hydroxyurea Excipients DESCRIPTION LEUKOCEL (Hydroxyurea capsules, USP) is available for oral use as capsules providing 200 mg, 300 mg, and 400 mg Hydroxyurea. Inactive ingredients: citric acid, gelatin, lactose, magnesium stearate, sodium phosphate, titanium dioxide and capsule colorants: FD&C Blue


Journal of Insect Physiology 54 (2008) 17–24Eicosanoids mediate melanotic nodulation reactions to viral infection inlarvae of the parasitic wasp, Pimpla turionellaeYonca Durmus-a, Ender Bu¨yu¨kgu¨zela, Burcin Terzia, Hasan Tunazb,David Stanleyc,Ã, Kemal Bu¨yu¨kgu¨zelaaDepartment of Biology, Faculty of Arts and Science, Karaelmas University, Zonguldak, TurkeybDepartment of Plant

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