Frozen Concentrate for Lemonade Deviating From Identity Standard; Temporary Permit for Market Testing
The Food and Drug Administration (FDA) is announcing that a temporary permit has been issued to Florida's Natural Growers, to market test a product designated as ``Frozen Concentrate for Lemonade 3+1 Ratio'' that deviates from the U.S. standard of identity for frozen concentrate for lemonade. The purpose of the temporary permit is to allow the applicant to measure customer acceptance of the product, identify mass production problems, and assess commercial feasibility.
Determination That MINOCIN (Minocycline Hydrochloride) Capsules Equivalent to 75 Milligrams Base Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) is announcing its determination that MINOCIN (minocycline hydrochloride) Capsules equivalent to (EQ) 75 milligrams (mg) base was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for minocycline hydrochloride capsules if all other legal and regulatory requirements are met.
New Animal Drugs; Albendazole
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pfizer, Inc. The supplemental NADA provides for use of albendazole oral suspension in nonlactating goats for the treatment of liver flukes.
Medicare Program; Changes to the Medicare Claims Appeal Procedures; Continuation of Effectiveness and Extension of Timeline for Publication of Final Rule
This notice announces the continuation of effectiveness of a Medicare interim final and the extension of the timeline for publication of the final rule. This notice is issued in accordance with section 1871(a)(3)(C) of the Social Security Act (the Act), which allows an interim final rule to remain in effect after the expiration of the timeline specified in section 1871(a)(3)(B) of the Act if prior to the expiration of the timeline, the Secretary publishes in the Federal Register a notice of continuation and explains the exceptional circumstances justifying the extension of the timeline for publishing a final rule.
Government-Owned Inventions; Availability for Licensing
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.
Submission for OMB Review; Comment Request; Cancer Care for Uninsured Individuals: A Feasibility Study (NCI)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on December 21, 2007 (Vol. 72, No. 245, p. 72741 and allowed 60-days for public comment. One public comment was received that questioned why the study was not funded by University of Alabama (UAB) funds. A response was made on February 8, 2008, that indicated that UAB was funding this study. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Cancer Care For Uninsured Individuals: A Feasibility Study. Type of Information Collection Request: New. Need and Use of Information Collection: The purpose of this information collection is to assess the feasibility of obtaining health insurance information for participants of the Prostate, Lung, Colon and Ovarian (PLCO) Cancer Screening Trial participants from health care providers and self reports. The ultimate objective is to compare the health care utilization of insured and uninsured PLCO participants. The PLCO data provides a unique opportunity to study health care seeking behavior after an abnormal cancer screening test and the effect of lack of health insurance. Participants who had positive cancer screening tests were referred to their doctors for follow-up care. No additional care was provided by the trial. The study collected detailed information on tests received for diagnosis, clinical presentation of disease, and cancer treatment. Since the PLCO original data collection had not recorded the health insurance of participants at the time of their screening, it is necessary to collect it retrospectively. This feasibility study will request information from 50 physicians and 150 participants. The aims are to determine the: (1) Total number of physicians to be contacted to obtain insurance information on all PLCO participants who had a positive cancer screening test; (2) Percentage of physicians willing and able to provide insurance information; (3) Percentage of participants with and without insurance; (4) Number of participants for whom insurance status can be only determined by self report; (5) Percentage of PLCO participants who accept to respond to the survey; (6) Percentage of individuals who are willing to provide information on insurance status; and, (7) Potential proportion of PLCO participants without health insurance. These results will be used to design a study to examine the health care behavior of insured and uninsured PLCO participants. This is relevant to understand the results of the PLCO Cancer Screening Trial and other screening trials currently being conducted in the U.S. The success of these trials is conditional on participants' access to care following a recommendation for follow-up. Uninsured individuals may be more likely to join these trials than insured ones in order to get free preventive care. They may also be more likely to not seek, or delay seeking, care after an abnormal screening test even though they are encouraged to get care and they may be highly motivated to receive the best care possible. It is relevant for other decision makers to understand whether uninsured persons are receiving appropriate care after abnormal screening results. The efforts to control cancer disease and the loss of life associated with it are concentrated on population wide screening. These endeavors may be compromised if a significant proportion of the population does not get appropriate follow-up after screening or does not get the care known to be effective for their disease. Frequency of Response: One time. Affected Public: Individuals and households; businesses or other for-profit. Type of Respondents: Individuals older than 55 who participated in the PLCO Screening trial and physicians who provided care for them. The annual reporting burden is shown in the following table.
Revisit User Fee Program for Medicare Survey and Certification Activities
This interim final rule with comment period implements the continuation of the revisit user fee program for Medicare Survey and Certification activities, in accordance with the statutory authority in the Continuing Appropriations Resolution entitled, ``Making further continuing appropriations for the fiscal year 2008, and for all other purposes,'' Public Law 110-149 (``Continuing Resolution'') signed into law on December 21, 2007. On September 19, 2007, we published a final rule that established a system of revisit user fees applicable to health care facilities that have been cited for deficiencies during initial certification, recertification or substantiated complaint surveys and require a revisit to confirm that previously-identified deficiencies have been corrected.
Medicare Program; Town Hall Meeting of the Medicare Evidence Development and Coverage Advisory Committee-April 30, 2008
This notice announces a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MedCAC) (``Committee''). We are soliciting comments from the scientific community and the public on prioritizing research topics of importance to the Medicare population. This meeting is a follow up to the CMS Evidentiary Priorities MedCAC meeting, which was held on October 22, 2007 to establish a list of evidentiary priorities for research to improve the health of Medicare beneficiaries. The Committee generally provides advice and recommendations about whether scientific evidence is adequate to determine whether certain medical items and services are reasonable and necessary under the Medicare statute. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Designation of Medically Underserved Populations and Health Professional Shortage Areas
This proposed rule would revise and consolidate the criteria and processes for designating medically underserved populations (MUPs) and health professional shortage areas (HPSAs), designations that are used in a wide variety of Federal government programs. These revisions are intended to improve the way underserved areas and populations are designated, by incorporating up-to-date measures of health status and access barriers, eliminating inconsistencies and duplication of effort between the two existing processes. These revisions are intended to reduce the effort and data burden on States and communities by simplifying and automating the designation process as much as possible while maximizing the use of technology. No changes are proposed at this time with respect to the criteria for designating dental and mental health HPSAs. Podiatric, vision care, pharmacy, and veterinary care HPSAs, which are no longer in use, would be abolished under the rules proposed below. Additional background information will be available for review on the web site of the Health Resources and Services Administration: http://bhpr.hrsa.gov/shortage. The methodology is also described in a journal article recently published in the Journal of Health Care for the Poor and Underserved entitled ``Designating Places and Populations as Medically Underserved: A Proposal for a New Approach'' (Ricketts et al, 2007).
Meeting of the Presidential Advisory Council on HIV/AIDS
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting. The meeting will be open to the public.
Privacy Act of 1974; Report of a New System of Records; Sanitation Facilities Construction Individual Applicant Records
In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``Sanitation Facilities Construction Individual Applicant Records (SFCIA), System No. 09-17-004.'' Under the provisions of the Indian Sanitation Facilities Act, Pub. L. 86-121 (42 U.S.C. 2004a), IHS is charged with carrying out the functions to determine basic individual and home eligibility for sanitation services. The primary purpose of this system is to determine eligibility of individuals and homes for sanitation services; budget justification for appropriation and project development to serve eligible homes and persons with sanitation facilities; to monitor, track and report status and progress of services provided; to maintain records on and to verify individuals' eligibility for services; and to link with the IHS Resource and Patient Management System (RPMS) for purposes of verifying and determining individuals' eligibility. Information retrieved from this system may be disclosed to: (1) Congressional offices in response to a verified inquiry; (2) other Federal agencies or Tribes that provide funding for or are involved in providing sanitation facilities to individuals or communities, and may be disclosed to individuals or communities, and may be disclosed to individuals specifically involved in the process of providing sanitation facilities, including but not limited to Tribal officials, Tribal housing authorities, Tribal utilities, contractors, State and local entities and consultants; (3) support litigation involving the agency; (4) referrals to the appropriate agency, whether Federal, State, or local, charged with enforcing or implementing the statute or rule, regulation or order; (5) HHS contractors and subcontractors for the purpose of collecting, compiling, aggregating, analyzing, or refining records; (6) other Federal or Tribal entities that provide sanitation facilities at the request of these entities in conjunction with a computer-matching program conducted by these entities to detect or curtail fraud and abuse in similar types of program services; and (7) appropriate Federal agencies and Departmental contractors in the event of data breaches either suspected or confirmed. Effective Dates: IHS filed a new system report with the Chair of the House Committee on Oversight and Government Reform, the Chair of the Senate Committee on Homeland Security and Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB) on February 28, 2008. To ensure that all parties have adequate time in which to comment, the new SOR, including routine uses, will become effective 40 days from the publication of the notice, or from the date it was submitted to OMB and the Congress, which is later, unless IHS invites comments on all portions of this notice.
Request for Notification From Industry Organizations Interested in Participating in the Selection Process for a Nonvoting Industry Representative on the Pediatric Advisory Committee and Request for Nominations for a Nonvoting Industry Representative on the Pediatric Advisory Committee
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on its Pediatric Advisory Committee notify FDA in writing. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for an upcoming vacancy on June 30, 2008, effective with this notice.
Privacy Act of 1974; Report of a New System of Records
In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system of records titled, ``Medicare Administrative Issue Tracker and Reporting of Operations (MAISTRO) System,'' System No. 09-70-0598. The purpose of the system is to capture and track casework/inquiries pertaining to Medicare Part A and Part B programs. The system will also provide a mechanism for recording data on a national level and will serve as a tool to leverage in performing analysis including identification of systemic trends. MAISTRO will record, track and monitor beneficiary and provider level inquiries & complaints. The system will contain information needed to research the inquiries, such as a beneficiary's health insurance claim number (HICN) or a Provider Identification Number (NPI). The primary purpose of the system is to collect and maintain information needed to provide a mechanism for CMS' central and regional office to capture, track, manage, report and trend inquiries, complaints and issues related to Fee-for-Service (FFS) programs. Information maintained in this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the Agency or by a contractor, consultant or CMS grantee; (2) assist another Federal or state agency, agency of a state government, an agency established by state law, or its fiscal agent; (3) facilitate research on the quality and effectiveness of care provided, as well as epidemiological projects; (4) support litigation involving the Agency; and (5) combat fraud, waste, and abuse in certain health benefits programs. We have provided background information about the modified system in the Supplementary Information section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See EFFECTIVE DATES section for comment period.
Privacy Act of 1974; Deletion of an Existing System of Records
In accordance with the requirements of the Privacy Act of 1974, CMS is deleting an existing system of records titled the ``Privacy Accountability Database (PAD),'' CMS System No. 09-70-0540, established at 67 FR 62482 (October 7, 2002).
HIV/AIDS Bureau; Policy Notice 99-02 Amendment #1
The HRSA HIV/AIDS Bureau (HAB) Policy Notice 99-02 entitled, The Use of Ryan White HIV/AIDS Program Funds for Housing Referral Services and Short-term or Emergency Housing Needs, provides grantees with guidance on the use of Title XXVI of the Public Health Service Act (Ryan White HIV/AIDS Program) funds for short-term and emergency housing assistance for persons living with HIV/AIDS. This Federal Register notice seeks to make public the final policy notice 99-02 Amendment 1 which places a cumulative period of 24 months on short-term and emergency housing assistance under the Ryan White HIV/AIDS Program, and clarifies and updates certain nomenclature found in the original housing policy 99-02. This policy becomes effective March 27, 2008.
Privacy Act of 1974; Report of a Modified or Altered System of Records
In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify or alter an existing SOR titled, ``1- 800 Medicare Helpline (HELPLINE), System No. 09-70-0535,'' modified at 68 Federal Register 25379 (May 12, 2003). We propose to modify existing routine use number 2 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will remain as routine use number 1. We will delete routine use number 6 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. We will broaden the scope of published routine uses number 8 and 9, authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating ``waste'' which refers to specific beneficiary/recipient practices that result in unnecessary cost to all Federally-funded health benefit programs. Finally, we will delete the section titled ``Additional Circumstances Affecting Routine Use Disclosures,'' that addresses ``Protected Health Information (PHI)'' and ``small cell size.'' The requirement for compliance with HHS regulation ``Standards for Privacy of Individually Identifiable Health Information'' does not apply because this system does not collect or maintain PHI. In addition, our policy to prohibit release if there is a possibility that an individual can be identified through ``small cell size'' is not applicable to the data maintained in this system. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or because of the impact of the MMA and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of the SOR is to provide general information to beneficiaries and future beneficiaries so that they can make informed Medicare decisions, maintain information on Medicare enrollment for the administration of the Medicare program, including the following functions: Ensuring proper Medicare enrollment, claims payment, Medicare premium billing and collection, coordination of benefits by validating and verifying the enrollment status of beneficiaries, and validating and studying the characteristics of persons enrolled in the Medicare program including their requirements for information. Information retrieved from this SOR will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the Agency or by contractors, consultants, or CMS grantees; (2) assist another Federal or state agency, agency of a state government, an agency established by state law, or its fiscal agent; (3) assist providers and suppliers of services for administration of Title XVIII of the Act; (4) assist third parties where the contact is expected to have information relating to the individual's capacity to manage his or her own affairs; (5) assist other insurers for processing individual insurance claims; (6) support litigation involving the Agency; and (7) combat fraud, waste, and abuse in certain health benefits programs. We have provided background information about the modified system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.
Proposed Collection; Comment Request; Brain Power! The NIDA Junior Scientist Program and the Companion Program, Brain Power! Challenge
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for the opportunity for public comment on proposed data collection projects, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Brain Power! The NIDA Junior Scientist Program, for grades K-5, and the companion program for Middle School, the Brain Power! Challenge. Type of Information Collection Request: This information collection request is for an EXTENSION of 0925-0542 that was obtained in 2005, and is requested for two additional years to meet scheduling availability for participating school districts. Need and Use of Information Collection: This is a request to evaluate the effectiveness of the Brain Power! Program's ability to (1) increase children's knowledge about the biology of the brain and the neurobiology of drug addiction, (2) increase positive attitudes toward science, careers in science, science as an enjoyable endeavor, and the use of animals in research; and stimulate interest in scientific careers; and (3) engender more realistic perceptions of scientists as being from many races, ages, and genders. The secondary goals of the evaluation are to determine the Program's impact on attitudes and intentions toward drug use. The findings will provide valuable information concerning the goals of NIDA's Science Education Program of increasing scientific literacy and stimulating interest in scientific careers. In order to test the effectiveness of the evaluation, information will be collected from students before and after exposure to the curriculum with pre- and post-test self-report measures. Surveys will also be administered to teachers after the completion of the program to examine ease and fidelity of implementation, as well as impact in knowledge and understanding of the neurobiology of addiction. Surveys will be administered to parents to obtain parental reaction and opinion on the materials and the degree to which parents find the curriculum informative and appropriate. Frequency of Response: On occasion. Affected Public: Elementary and middle school students, teachers, and parents. Type of Respondents: Students, Teachers, and Parents. The reporting burden is as follows: Estimated Number of Respondents: 1,337; Estimated Number of Responses per Respondent: 2; Average Burden Hours Per Response: .25; Estimated Total Annual Burden Hours Requested: 640.5. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. The estimated annualized burden is summarized below.
Privacy Act of 1974; Report of a Modified or Altered System of Records
In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify or alter existing system of records titled, ``Enrollment Data Base (EDB), System No. 09-70-0502, last modified 67 Federal Register 3203 (January 23, 2002). The EDB currently maintains enrollment-related data, data elements pertaining to Medicare Secondary Payer (MSP), and data regarding Direct billing and Third Part premium collection information for Medicare premiums. We are amending the purpose of the EDB to include maintaining enrollment and entitlement data currently maintained in the following CMS systems of records: Medicare Beneficiary Database (MBD), System No. 09-70-0536; and the Medicare Prescription Drug System (MARx), System No. 09-70- 4001. We are modifying the language in published routine use number 1 to permit disclosures to a grantee of a CMS-administered grant program that perform a task for the agency. CMS occasionally contracts out certain of its functions when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor, consultant or grantee whatever information is necessary for the contractor, consultant, or grantee to fulfill its duties. We will modify existing routine use number 5 that permits disclosure to Peer Review Organizations (PRO). Organizations previously referred to as PROs will be renamed to read: Quality Improvement Organizations (QIO). Information will be disclosed to QIOs for health care quality improvement projects. The modified routine use will be renumbered as routine use number 5. We will delete published routine use number 8 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. We are modifying the language in the remaining disclosure provisions to provide a proper explanation as to the need for the disclosure and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS system notices. The primary purpose of the SOR is to maintain information on Medicare enrollment for the administration of the Medicare program, including the following functions: Ensuring proper Medicare enrollment, claims payment, Direct billing and Third Party premium collection information, coordination of benefits by validating and verifying the enrollment status of beneficiaries, and validating and studying the characteristics of persons enrolled in the Medicare program including their requirements for information. Information retrieved from this SOR will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the Agency or by agency contractors, consultants, or to a grantee of a CMS-administered grant; (2) assist another Federal or state agency, agency of a state government, an agency established by state law, or its fiscal agent; (3) assist third parties where the contact is expected to have information relating to the individual's capacity to manage his or her own affairs; (4) assist providers and suppliers of services for administration of Title XVIII of the Act; (5) support Quality Improvement Organizations (QIO); (6) assist other insurers for processing individual insurance claims; (7) facilitate research on the quality and effectiveness of care provided, as well as payment-related and epidemiological projects; (8) support litigation involving the Agency; and (9) combat fraud and abuse in certain health benefits programs. We have provided background information about the new system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.
Limitation on Use of Funds and Eligibility for Funds Made Available by the Office of Refugee Resettlement, Within the Administration for Children and Families, of the Department of Health and Human Services, To Monitor and Combat Trafficking in Persons
This proposed rule would implement two provisions of the Trafficking Victims Protection Act (TVPA) (22 U.S.C. Chapter 78), as amended by the Trafficking Victims Protection Reauthorization Act (TVPRA) of 2003 (Pub. L. 108-193), that provide limitations on the use of funds. The provisions at Title 22 of the U.S.C. 7110(g) prohibit programs from using trafficking funds to promote, support, or advocate the legalization or practice of prostitution. They make ineligible to receive funds any organization that promotes, supports, or advocates the legalization or the practice of prostitution if the organization operates a program that targets victims of severe forms of trafficking, unless the organization provides assistance to individuals solely after they are no longer engaged in activities that resulted from their being trafficked. This proposed rule applies to funds that Congress appropriates for the U.S. Department of Health and Human Services for anti-trafficking purposes under Title 22 of the United States Code.
Chafee National Youth in Transition Database
This final rule adds new regulations to require States to collect and report data to ACF on youth who are receiving independent living services and on the outcomes of certain youth who are in foster care or who age out of foster care. The final rule implements the data collection requirements of the Foster Care Independence Act of 1999 (Pub. L. 106-169) as incorporated into the Social Security Act.
Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products,'' dated February 2008. The guidance document provides recommendations to sponsors for using methods other than sterility testing to confirm the integrity of container and closure systems as part of stability testing for sterile biological products, human and veterinary drugs, and medical devices. The guidance document does not apply to sterility testing methods for product sterility testing prior to release, as container and closure system integrity tests cannot demonstrate a product's initial sterility. The guidance announced in this notice finalizes the draft guidance entitled ``Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products,'' dated January 1998.
Food Labeling: Health Claims; Soluble Fiber From Certain Foods and Risk of Coronary Heart Disease
The Food and Drug Administration (FDA) is amending the health claim regulation entitled ``Soluble fiber from certain foods and risk of coronary heart disease (CHD)'' to add barley betafiber as an additional eligible source of beta-glucan soluble fiber. Barley betafiber is the ethanol precipitated soluble fraction of cellulase and alpha-amylase hydrolyzed whole grain barley flour. FDA is taking this action in response to a health claim petition submitted by Cargill, Inc. FDA previously concluded that there was significant scientific agreement that a claim characterizing the relationship between beta- glucan soluble fiber of certain whole oat and whole grain barley products and CHD risk is supported by the totality of publicly available scientific evidence. Based on the totality of publicly available scientific evidence, FDA now has concluded that in addition to certain whole oat and whole grain barley products, barley betafiber is also an appropriate source of beta-glucan soluble fiber. Therefore, FDA is amending the health claim regulation entitled ``Soluble fiber from certain foods and risk of CHD'' to include barley betafiber as another eligible source of beta-glucan soluble fiber.
Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables; Availability
The Food and Drug Administration (FDA) is announcing the availability of a final guidance document entitled ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables'' (the fresh-cut guidance or guidance). Previously, FDA announced the availability of the fresh-cut guidance as a ``draft final'' document, pending approval by the Office of Management and Budget (OMB) of the information collection provisions in the guidance. FDA is publishing this notice to announce that the fresh- cut guidance is now final. The text of the guidance has not changed from the previously published draft final version. The fresh-cut guidance complements FDA's current good manufacturing practice (CGMP) requirements for foods by providing specific guidance on the processing of fresh-cut produce. The fresh-cut guidance and the CGMP regulations are intended to assist processors in minimizing microbial food safety hazards common to the processing of most fresh-cut fruits and vegetables sold to consumers and retail establishments in a ready-to- eat form.