Compliance Policy Guide; “Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002;” Availability, 20955-20956 [E9-10556]

Download as PDF 20955 Federal Register / Vol. 74, No. 86 / Wednesday, May 6, 2009 / Notices EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued Number of respondents Form mode Total burden hours Average hourly wage rate * Total cost burden Adult SAQ ................................................................................................. Diabetes care SAQ ................................................................................... Permission forms for the MEPS–MPC ..................................................... 21,000 1,800 15,000 2,450 90 3,900 19.56 19.56 19.56 47,922 1,760 76,284 Subtotal for the MEPS–HC ............................................................... MEPS–MPC: Home care for health care providers questionnaire ................................. Home care for non-health care providers questionnaire .......................... Office-based providers questionnaire ....................................................... Separately billing doctors questionnaire ................................................... Hospitals questionnaire ............................................................................ Institutions (non-hospital) questionnaire ................................................... Pharmacies questionnaire ........................................................................ Subtotal for the MEPS–MPC ............................................................. 52,800 62,690 na 1,226,216 441 23 13,665 12,450 5,402 72 7,760 39,813 239 13 6,605 1,245 2,926 9 9,040 20,077 14.24 19.56 14.24 14.24 14.24 14.24 14.24 na 3,403 254 94,055 17,729 41,666 128 128,730 285,965 Grand Total ................................................................................ 92,613 82,767 na 1,512,181 * Based upon the mean of the average wages for Healthcare Support Workers, All Other (31–9099) and All Occupations (00–0000), Occupational Employment Statistics, May 2007 National Occupational Employment and Wage Estimates United States, U.S. Department of Labor, Bureau of Labor Statistics. https://www.bls.gov/oes/current/oes_nat.htm#b29-0000. Estimated Annual Costs to the Federal Government Exhibit 3 shows the total and annualized cost of this information collection. The cost associated with the design and data collection of the MEPS– HC and MEPS–MPC is estimated to be $47.6 million in each of the next three fiscal years. EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST Total cost (in million) Cost component Sampling Activities ............................................................................................................................................... Interviewer Recruitment and Training ................................................................................................................. Data Collection Activities ..................................................................................................................................... Data Processing .................................................................................................................................................. Production of Public Use Data Files ................................................................................................................... Project Management ............................................................................................................................................ $2.79 8.52 86.7 21.39 19.53 3.93 mstockstill on PROD1PC66 with NOTICES Total .............................................................................................................................................................. Request for Comments In accordance with the above-cited Paperwork Reduction Act legislation, comments on AHRQ’s information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ’s estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and VerDate Nov<24>2008 18:36 May 05, 2009 Jkt 217001 included in the Agency’s subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record. Dated: April 27, 2009. Carolyn M. Clancy, Director. [FR Doc. E9–10406 Filed 5–5–09; 8:45 am] BILLING CODE 4160–90–M PO 00000 Annualized cost (in million) 142.8 $0.93 2.84 28.9 7.13 6.51 1.31 47.6 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0487] (formerly Docket No. 2007D–0260) Compliance Policy Guide; ‘‘Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002;’’ Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a Compliance Policy Guide (CPG) entitled ‘‘Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.’’ The CPG provides written guidance to FDA’s and Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\06MYN1.SGM 06MYN1 20956 Federal Register / Vol. 74, No. 86 / Wednesday, May 6, 2009 / Notices mstockstill on PROD1PC66 with NOTICES Customs and Border Protection’s (CBP’s) staff on enforcement of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the agency’s implementing regulations, which require prior notice for food imported or offered for import into the United States. DATES: Submit written or electronic comments concerning the CPG at any time. ADDRESSES: Submit written comments on the CPG to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the CPG. Submit written requests for single copies of the CPG to the Division of Compliance Policy (HFC–230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send two selfaddressed adhesive labels to assist that office in processing your request, or fax your request to 240–632–6861. FOR FURTHER INFORMATION CONTACT: Laura Draski, Office of Regulatory Affairs (HFC–100), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 866–521–2297. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of November 7, 2008 (73 FR 66411), FDA announced the availability of a draft CPG entitled ‘‘Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.’’ After considering the one comment received, FDA revised the CPG, with CBP concurrence, where appropriate. The revised CPG provides written guidance to FDA’s and CBP’s staff on enforcement of section 307 of the Bioterrorism Act and the agency’s implementing regulations, which require prior notice for food imported or offered for import into the United States. FDA is issuing this CPG as level 1 guidance consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The CPG represents the agency’s current thinking on its enforcement policy concerning prior notice. It does not create or confer any rights for or on any person and does not operate to bind FDA, or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. VerDate Nov<24>2008 18:36 May 05, 2009 Jkt 217001 II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic copies or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The CPG and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access An electronic version of the CPG is available on the Internet at https:// www.fda.gov/ora under ‘‘Compliance References.’’ Dated: April 29, 2009. Michael A. Chappell, Acting Associate Commissioner for Regulatory Affairs. [FR Doc. E9–10556 Filed 5–4–09; 4:15 pm] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852–3804; telephone: 301/ 496–7057; fax: 301/402–0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. ADDRESSES: PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 Small Molecule Activators of Human Pyruvate Kinase for Treatment of Cancer and Enzyme-Deficient Hemolytic Anemia Description of Technology: NIH investigators have discovered a series of small compounds with the potential to treat a variety of cancers as well as hemolytic anemia. Contrary to most cancer medications, these molecules can be non-toxic to normal cells because they target a protein specific to the metabolic pathways in tumors, thus representing a significant clinical advantage over less-specific chemotherapeutics. The invention described here is a series of small molecules that activate pyruvate kinase (PK) isoform M2. PK– M2 is a critical metabolic enzyme that is affected in all forms of cancer. Inactivation of PK–M2 leads to a buildup of metabolic intermediates inside the cell. Tumor cells require a buildup of metabolic intermediates in order to undergo rapid cell growth and proliferation. Hence, activation of PK– M2 in tumor cells may prevent the buildup of metabolic intermediates and thereby stall tumor cell proliferation or destroy the tumor cells. Further, while in normal adult cells only PK isoforms R, L, or M1 are active, in all tumors only PK–M2 is active. Therefore, PK–M2 activation would affect only tumor cells, and small-molecule PK–M2 activators are not expected to be toxic to healthy cells. In addition, in patients with PK–R deficiency the buildup of metabolic intermediates in red blood cells ultimately leads to the loss of water from the cells and cell death. Smallmolecule induced activation of PK–R in PK-deficient red blood cells may enhance vitality of these cells and decrease or eliminate enzyme-deficient hemolytic anemia in a patient. Applications: Therapeutic for cancer; Therapeutic for enzyme-deficient hemolytic anemia. Development Status: Early stage. Market: In the United States in 2008, approximately 1.4 million people were diagnosed with cancer. In addition, approximately 12,000 people in the United States are chronically affected by PK-deficient hemolytic anemia. Inventors: Craig J. Thomas et al. (NHGRI). Publications: In preparation. Patent Status: U.S. Provisional Application No. 61/104,091 filed 09 Oct 2008 (HHS Reference No. E–326–2008/ 0–US–01). Licensing Status: Available for licensing. Licensing Contact: Steve Standley, PhD; 301–435–4074; sstand@od.nih.gov. E:\FR\FM\06MYN1.SGM 06MYN1

Agencies

[Federal Register Volume 74, Number 86 (Wednesday, May 6, 2009)]
[Notices]
[Pages 20955-20956]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-10556]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0487] (formerly Docket No. 2007D-0260)


Compliance Policy Guide; ``Sec. 110.310 Prior Notice of Imported 
Food Under the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002;'' Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a Compliance Policy Guide (CPG) entitled ``Sec. 110.310 
Prior Notice of Imported Food Under the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002.'' The CPG provides 
written guidance to FDA's and

[[Page 20956]]

Customs and Border Protection's (CBP's) staff on enforcement of the 
Public Health Security and Bioterrorism Preparedness and Response Act 
of 2002 (the Bioterrorism Act) and the agency's implementing 
regulations, which require prior notice for food imported or offered 
for import into the United States.

DATES: Submit written or electronic comments concerning the CPG at any 
time.

ADDRESSES: Submit written comments on the CPG to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to https://www.regulations.gov. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the CPG.
    Submit written requests for single copies of the CPG to the 
Division of Compliance Policy (HFC-230), Office of Enforcement, Food 
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send 
two self-addressed adhesive labels to assist that office in processing 
your request, or fax your request to 240-632-6861.

FOR FURTHER INFORMATION CONTACT: Laura Draski, Office of Regulatory 
Affairs (HFC-100), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 866-521-2297.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 7, 2008 (73 FR 66411), FDA 
announced the availability of a draft CPG entitled ``Sec. 110.310 Prior 
Notice of Imported Food Under the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002.'' After considering 
the one comment received, FDA revised the CPG, with CBP concurrence, 
where appropriate. The revised CPG provides written guidance to FDA's 
and CBP's staff on enforcement of section 307 of the Bioterrorism Act 
and the agency's implementing regulations, which require prior notice 
for food imported or offered for import into the United States.
    FDA is issuing this CPG as level 1 guidance consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The CPG represents 
the agency's current thinking on its enforcement policy concerning 
prior notice. It does not create or confer any rights for or on any 
person and does not operate to bind FDA, or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic copies or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. The CPG and received comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

III. Electronic Access

    An electronic version of the CPG is available on the Internet at 
https://www.fda.gov/ora under ``Compliance References.''

    Dated: April 29, 2009.
Michael A. Chappell,
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. E9-10556 Filed 5-4-09; 4:15 pm]
BILLING CODE 4160-01-S

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