Kemira Oyj; Filing of Food Additive Petition (Animal Use); Partially Ammoniated Formic Acid; Correction, 14472 [E8-5453]

Download as PDF 14472 Federal Register / Vol. 73, No. 53 / Tuesday, March 18, 2008 / Notices approval according to the prescribed content and format. • 21 CFR 208.24(e)—Each authorized dispenser of a prescription drug product for which a Medication Guide is required, when dispensing the product to a patient or to a patient’s agent, must provide a Medication Guide directly to each patient unless an exemption applies under § 208.26 (21 CFR 208.26). • Section 208.26(a)—Requests may be submitted for exemption or deferral from particular Medication Guide content or format requirements. • 21 CFR 314.70(b)(3)(ii) and 21 CFR 601.12(f)—Application holders must submit changes to Medication Guides to FDA for prior approval as supplements to their applications. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents 21 CFR Section 208.20 Annual Frequency per Response Total Annual Responses Hours Per Response Total Hours 10 1 10 320 3,200 208.24(e) 59,000 5,000 295 million .0014 413,000 208.26(a) 1 1 1 4 4 314.70(b)(3)(ii) and 601.12(f) 5 1 5 72 360 Total 416,564 Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA through FDMS only. Dated: March 11, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8–5384 Filed 3–17–08; 8:45 am] In FR Doc. E8–316, published on January 11, 2008 (73 FR 2055), the following correction is made: On page 2055, in the second column, in the SUMMARY and SUPPLEMENTARY INFORMATION sections, ‘‘Oyi’’ is corrected to read ‘‘Oyj’’. SUPPLEMENTARY INFORMATION: Dated: March 7, 2008. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. E8–5453 Filed 3–17–08; 8:45 am] BILLING CODE 4160–01–S BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Food and Drug Administration [Docket No. 2007F–0478] Kemira Oyj; Filing of Food Additive Petition (Animal Use); Partially Ammoniated Formic Acid; Correction AGENCY: Food and Drug Administration, mstockstill on PROD1PC66 with NOTICES Health Resources and Services Administration, HHS. AGENCY: Notice of Meeting of the Advisory Committee on Organ Transplantation. ACTION: HHS. ACTION: Meeting of the Advisory Committee on Organ Transplantation Notice; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a document announcing the filing of a food additive petition that appeared in the Federal Register of January 11, 2008. FDA is correcting the name of the petitioner which was misspelled during document drafting. DATES: This correction is effective March 18, 2008. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV–6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–267–9019, email: george.haibel@fda.hhs.gov. VerDate Aug<31>2005 17:39 Mar 17, 2008 Jkt 214001 SUMMARY: Pursuant to Public Law 92– 463, the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the fourteenth meeting of the Advisory Committee on Organ Transplantation (ACOT), Department of Health and Human Services (HHS). The meeting will be held from approximately 9 a.m. to 5:30 p.m. on May 5, 2008, and from 9 a.m. to 3 p.m. on May 6, 2008, at the Hilton Washington D.C./Rockville Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852. The meeting will be open to the public; however, seating PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 is limited and pre-registration is encouraged (see below). SUPPLEMENTARY INFORMATION: Under the authority of 42 U.S.C. Section 217a, Section 222 of the Public Health Service Act, as amended, and 42 CFR 121.12 (2000), ACOT was established to assist the Secretary in enhancing organ donation, ensuring that the system of organ transplantation is grounded in the best available medical science, and assuring the public that the system is as effective and equitable as possible, and, thereby, increasing public confidence in the integrity and effectiveness of the transplantation system. ACOT is composed of up to 25 members, including the Chair. Members are serving as Special Government Employees and have diverse backgrounds in fields such as organ donation, health care public policy, transplantation medicine and surgery, critical care medicine and other medical specialties involved in the identification and referral of donors, non-physician transplant professions, nursing, epidemiology, immunology, law and bioethics, behavioral sciences, economics and statistics, as well as representatives of transplant candidates, transplant recipients, organ donors, and family members. ACOT will hear presentations on the ‘‘Kidney Disease Outcome Quality Initiative/Early Kidney Transplantation Conference’’ held on March 19–20, 2007; adolescent/medication nonadherence/transitioning from pediatric-adolescent care to adult care; revised informed consent recommendation; recovery/allocation/ transplantation practices outside the United States; and a final report on the economics of transplantation. The four ACOT work groups also will update the E:\FR\FM\18MRN1.SGM 18MRN1

Agencies

[Federal Register Volume 73, Number 53 (Tuesday, March 18, 2008)]
[Notices]
[Page 14472]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-5453]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007F-0478]


Kemira Oyj; Filing of Food Additive Petition (Animal Use); 
Partially Ammoniated Formic Acid; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a 
document announcing the filing of a food additive petition that 
appeared in the Federal Register of January 11, 2008. FDA is correcting 
the name of the petitioner which was misspelled during document 
drafting.

DATES: This correction is effective March 18, 2008.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-267-9019, e-mail: 
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In FR Doc. E8-316, published on January 11, 
2008 (73 FR 2055), the following correction is made:
    On page 2055, in the second column, in the SUMMARY and 
SUPPLEMENTARY INFORMATION sections, ``Oyi'' is corrected to read 
``Oyj''.

    Dated: March 7, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-5453 Filed 3-17-08; 8:45 am]
BILLING CODE 4160-01-S
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