Department of Health and Human Services March 2008 – Federal Register Recent Federal Regulation Documents

Results 51 - 100 of 275
Medicare and State Health Care Programs: Fraud and Abuse; Issuance of Advisory Opinions by OIG
Document Number: E8-6164
Type: Rule
Date: 2008-03-26
Agency: Department of Health and Human Services, Office of the Secretary, Office of Inspector General, Inspector General Office, Health and Human Services Department, Centers for Medicare & Medicaid Services
In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996, this final rule amends the OIG regulations at 42 CFR part 1008 by (1) revising the process for advisory opinion requestors to submit payments for advisory opinion costs, and (2) clarifying that notices to the public announcing procedures for processing advisory opinion requests will be published on OIG's Web site.
Fiscal Year (FY) 2008 Funding Opportunity
Document Number: E8-6084
Type: Notice
Date: 2008-03-26
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award approximately $500,000 (total costs) per year for up to three years to the American Society of Addiction Medicine (ASAM). This is not a formal request for applications. Assistance will be provided only to the American Society of Addiction Medicine (ASAM) based on the receipt of a satisfactory application that is approved by an independent review group. Funding Opportunity Title: TI-08-014. Catalog of Federal Domestic Assistance (CFDA) Number: 93.243. Authority: Section 509 of the Public Health Service Act, as amended. Justification: Only the American Society of Addiction Medicine (ASAM) is eligible to apply. The Substance Abuse and Mental Health Services Administration (SAMHSA) is seeking to award a single source grant to the American Society of Addiction Medicine (ASAM) to establish a national mentoring network offering support (clinical updates, evidence-based outcomes and training) free of charge to physicians and other medical professionals in the appropriate use of methadone for the treatment of chronic pain and opioid addiction. SAMHSA is responsible for certifying over 1,000 Opioid Treatment Programs (OTPs) that use methadone and buprenorphine in the treatment of opioid addiction. This initiative will help address the nation's rise in methadone-associated deaths that has been spurred by misuse/abuse and fatal drug interactions involving methadone. According to the National Center for Health Statistics (NCHS), methadone poisoning deaths nationwide increased 390% from 786 deaths in 1999 to 3,849 deaths in 2004, and on going data indicate that the number of deaths in many states continued to increase in 2005 and 2006. Thus, prompt and direct implementation of this cooperative agreement is necessary to help ensure public health and safety. To address this healthcare crisis in a timely manner, eligibility for the cooperative agreement is limited to ASAM to establish a national mentoring network and to carry out the dissemination of information and education as it relates to methadone use in the treatment of opioid addiction and chronic pain. ASAM presently provides a parallel service under a SAMHSA cooperative agreement to operate a Physician Clinical Support System (PCSS) to assist physicians with issues related to office-based treatment of opioid dependence with buprenorphine. As a result, ASAM is in the unique position to have the infrastructure and capacity in place to expeditiously meet the specific and unique needs outlined in this announcement. In addition, ASAM has demonstrated in the past (through the PCSS project) the capability to implement and achieve the goals of this program.
Civil Money Penalties Hearings; Maximum Penalty Amounts; Technical Amendment
Document Number: E8-6082
Type: Rule
Date: 2008-03-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending its civil money penalties regulations to correct an inadvertent typographical error. This action is editorial in nature and is intended to improve the accuracy of the agency's regulations.
Agency Information Collection Activities; Proposed Collection; Comment Request; Appeals of Science-Based Decisions Above the Division Level at the Center for Veterinary Medicine
Document Number: E8-6065
Type: Notice
Date: 2008-03-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements for appeals of science-based decisions above the division level at the Center for Veterinary Medicine (CVM).
New Animal Drugs for Use in Animal Feeds; Bacitracin Methylene Disalicylate and Nicarbazin
Document Number: E8-6063
Type: Rule
Date: 2008-03-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Alpharma, Inc. The NADA provides for use of approved, single-ingredient Type A medicated articles containing bacitracin methylene disalicylate and nicarbazin to formulate two-way combination drug Type C medicated feeds for broiler chickens.
Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient
Document Number: E8-6061
Type: Notice
Date: 2008-03-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the procedure by which a manufacturer or distributor of dietary supplements or of a new dietary ingredient is to submit to FDA information upon which the manufacturer or distributor has based its conclusion that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe.
Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Recall Regulations
Document Number: E8-6060
Type: Notice
Date: 2008-03-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on requirements related to the recall of infant formula.
Frozen Concentrate for Lemonade Deviating From Identity Standard; Temporary Permit for Market Testing; Correction
Document Number: E8-6056
Type: Notice
Date: 2008-03-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration is correcting a notice that appeared in the Federal Register of February 29, 2008 (73 FR 11095). The document announced 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.'' The document was published with an incorrect value for the Brix (measure of concentration of sugars in juice). This document corrects the error.
Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Records; Electronic Signatures
Document Number: E8-6055
Type: Notice
Date: 2008-03-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection provisions relating to FDA's electronic records and electronic signatures.
Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Technical Amendment
Document Number: E8-6052
Type: Rule
Date: 2008-03-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending its regulations to change the fax number to which food facility registration forms under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) can be sent. This action is editorial in nature and is intended to improve the accuracy of the agency's regulations.
Preparation for International Conference on Harmonization Meetings in Portland, Oregon; Public Meeting
Document Number: 08-1077
Type: Notice
Date: 2008-03-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Preparation for ICH Meetings in Portland, Oregon'' to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in Portland, Oregon. The topics to be discussed are the topics for discussion at the forthcoming ICH Steering Committee Meeting. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Groups meetings in Portland, Oregon, June 2-5, 2008, at which discussion of the topics underway and the future of ICH will continue. Date and Time: The meeting will be held on Friday April 4, 2008, from 12:30 pm to 5 p.m. Location: The meeting will be held at 5600 Fishers Lane, 3rd floor, Conference Room G and H, Rockville, MD 20857. For security reasons, all attendees are asked to arrive no later than 12:25 p.m., as you will be escorted from the front entrance of 5600 Fishers Lane to Conference Room G and H. Contact Person: All participants must register with Tammie Bell, Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, by e-mail: Tammie.bell@fda.hhs.gov or FAX: 301-480-0003. Registration and Requests for Oral Presentations: Send registration information (including name, title, firm name, address, telephone, and fax number), written material, and requests to make oral presentations, to the contact person by April 3, 2008. If you need special accommodations due to a disability, please contact Tammie Bell at least 7 days in advance.
International Conference on Harmonisation; Draft Guidance on S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use; Availability
Document Number: 08-1076
Type: Notice
Date: 2008-03-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance updates and combines information from two ICH guidances, ``S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals'' and ``S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals.'' The draft guidance is intended to help facilitate drug development programs, ensure patient safety, and reduce animal usage.
Proposed Information Collection Activity; Comment Request
Document Number: E8-5952
Type: Notice
Date: 2008-03-25
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Proposed Information Collection Activity; Comment Request
Document Number: E8-5951
Type: Notice
Date: 2008-03-25
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Availability of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Test Method Evaluation Report: In Vitro
Document Number: E8-5936
Type: Notice
Date: 2008-03-25
Agency: Department of Health and Human Services
NICEATM announces availability of the ICCVAM Test Method Evaluation Report: In Vitro Cytotoxicity Test Methods for Estimating Starting Doses for Acute Oral Systemic Toxicity Tests (NIH Publication 07-4519). The report describes two in vitro basal cytotoxicity neutral red uptake (NRU) test methods that can be used for estimating starting doses for acute oral toxicity tests. The report includes ICCVAM's (a) final test method recommendations on the use of these two test methods, (b) recommended test method protocols for future use, (c) recommendations for future studies to further characterize the usefulness and limitations of in vitro methods for assessing acute systemic toxicity, and (d) recommended performance standards for tests with similar scientific principles and that measure or predict acute oral systemic toxicity. The report recommends the use of these methods in a weight-of-evidence approach to determine starting doses for acute oral systemic toxicity tests with rodents. The report also recommends that these in vitro test methods be considered before using animals for acute oral systemic toxicity testing and used when determined appropriate. NICEATM also announces the availability of the final Background Review Document: In Vitro Cytotoxicity Test Methods for Estimating Acute Oral Systemic Toxicity (BRD) (NIH Publication 07-4518). The BRD provides data and analyses from a collaborative international validation study organized by NICEATM and the European Centre for the Validation of Alternative Methods (ECVAM) to evaluate the usefulness and limitations of two in vitro basal cytotoxicity NRU test methods using either BALB/c 3T3 mouse fibroblasts (3T3) or primary human epidermal keratinocytes (NHK) for estimating acute oral rodent toxicity. Electronic copies of the ICCVAM Test Method Evaluation Report and the BRD are available from the ICCVAM/NICEATM Web site at http:// iccvam.niehs.nih.gov or by contacting NICEATM (see FOR FURTHER INFORMATION CONTACT). The ICCVAM Test Method Evaluation Report and the final BRD have been forwarded to U.S. Federal agencies for regulatory and other acceptance considerations where applicable. Responses will be posted on the ICCVAM/NICEATM Web site as they are received.
New Animal Drugs for Use in Animal Feed; Pyrantel; Technical Amendment
Document Number: E8-5928
Type: Rule
Date: 2008-03-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending its animal drug regulations to correct an inadvertent omission in the list of concentrations of pyrantel tartrate Type A medicated articles approved for use by Phibro Animal Health. This action is being taken to improve the accuracy of the animal drug regulations.
Global Harmonization Task Force, Study Group 4; Final Document; Availability
Document Number: E8-5927
Type: Notice
Date: 2008-03-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a final document that has been prepared by Study Group 4 of the Global Harmonization Task Force (GHTF). This document represents a harmonized proposal and recommendation from Study Group 4 of the GHTF that may be used by governments developing and updating their regulatory requirements for medical devices. This document is intended to provide information only and does not describe current regulatory requirements; elements of this document may not be consistent with current U.S. regulatory requirements.
Office of the National Coordinator for Health Information Technology; American Health Information Community Confidentiality, Privacy, & Security Workgroup Meeting
Document Number: E8-5853
Type: Notice
Date: 2008-03-25
Agency: Department of Health and Human Services
This notice announces the 18th meeting of the American Health Information Community Confidentiality, Privacy, & Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.)
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: E8-5823
Type: Notice
Date: 2008-03-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: E8-5822
Type: Notice
Date: 2008-03-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: E8-5818
Type: Notice
Date: 2008-03-25
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the Vaccine Safety Working Group
Document Number: E8-5892
Type: Notice
Date: 2008-03-24
Agency: Department of Health and Human Services
The Department of Health and Human Services (DHHS) is hereby giving notice that the National Vaccine Program Office (NVPO) will convene a meeting of NVAC's Vaccine Safety Working Group. The meeting is open to the public.
Notice of Hearing: Reconsideration of Disapproval of Texas State Plan Amendment (SPA) 07-011
Document Number: E8-5881
Type: Notice
Date: 2008-03-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces an administrative hearing to be held on May 7, 2008, at the CMS Dallas Regional Office, 1301 Young Street, Room 1196, Dallas, Texas 75202, to reconsider CMS' decision to disapprove Texas SPA 07-011. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by April 8, 2008.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E8-5862
Type: Notice
Date: 2008-03-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E8-5861
Type: Notice
Date: 2008-03-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-5860
Type: Notice
Date: 2008-03-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-5859
Type: Notice
Date: 2008-03-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Collection; Comment Request; Inventory and Evaluation of Clinical Research Networks
Document Number: E8-5816
Type: Notice
Date: 2008-03-24
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Center for Research Resource (NCRR), 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: Inventory and Evaluation of Clinical Research Networks. Type of Information Collection Request: Revision of OMB 0925-0550. Expiration: 07/31/08. Need and Use of Information Collection: Through the original data collection, the IECRN project identified and surveyed clinical research networks to obtain data for two purposes: (1) To create a web-based inventory of clinical research networks that can be accessed by the clinical research community and the general public and (2) to prepare a detailed description of existing network practices from a sample of identified networks. The current request is to continue collecting data for the first purpose only. The instrument known as the Core Survey will be used to collect information to confirm that the respondent is truly a clinical research network, plus basic characteristics about each identified clinical research network to be included in the web-based inventory. The information for the inventory database includes the network's name, address, contact information, funding sources, age, geographic coverage, size, composition, and populations and diseases of focus. Permission to post the network's data in the web-based public inventory will be requested, and only those networks that agree will have their information posted. Currently the inventory includes ``network profiles'' for approximately 270 clinical research networks. While this number is believed to represent most of the existing networks, some networks have not yet been identified, are unaware of the existence of the inventory, or are newly formed since the original data collection occurred. In addition, each network in the inventory is requested annually to update the information posted in its ``network profile'' to ensure that the inventory is complete and accurate. Frequency of Response: Once (Core Survey), Annually (Network Updates). Affected Public: Individuals. Type of Respondents: Health Professionals (Physicians and others involved in research networks).
Government-Owned Inventions; Availability for Licensing
Document Number: E8-5813
Type: Notice
Date: 2008-03-24
Agency: Department of Health and Human Services, National Institutes of Health
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.
Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: E8-5810
Type: Notice
Date: 2008-03-24
Agency: Food and Drug Administration, Department of Health and Human Services
Submission for OMB Review; Comment Request
Document Number: E8-5761
Type: Notice
Date: 2008-03-24
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: E8-5706
Type: Notice
Date: 2008-03-24
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Emergency Review; Comment Request; Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank
Document Number: E8-5824
Type: Notice
Date: 2008-03-21
Agency: Department of Health and Human Services, National Institutes of Health
In accordance with Section 3507(j) of the Paperwork Reduction Act of 1995, the National Institutes of Health hereby publishes notification of an Emergency Clearance for the expansion of the information related to the ``Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank.'' The expanded program will include information on certain clinical trials of drugs, biologics, and devices, whether or not they relate to serious and life-threatening diseases. The information collection is essential to the mission of the FDA and National Institutes of Health [42 U.S.C. 282(j)(2)(A)(ii)] and is critical to meeting their roles in the Clinical Trial Registry that was expanded by Public Law 110-85, which was enacted on September 27, 2007. NIH cannot reasonably comply with the normal clearance procedures for information collection, because the use of normal procedures will delay the collection and hinder the agency in accomplishing its mission and meeting new statutory requirements, to the detriment of the public good. Compelling reason exists for the collection of required information for successful planning and implementation of the expansion of the Clinical Trial Registry, as described in Public Law 110-85. This information collection is essential to the effective stewardship of Federal Funds. After consultation with other agencies and NIH components, NIH has determined that the information is not currently available in any single, reliable, accessible source. Proposed Collection: Title: Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank; Type of Information Collection Request: New; Form Number: NA; Need and Use of Information Collection: In compliance with provisions of Title VIII of Public Law 110-85 (Food and Drug Administration Amendments Act of 2007) the National Institutes of Health is modifying the clinical trial registry established under previous law [ClinicalTrials.gov, established in response to FDAMA, Section 113]. The registry collects specified information on certain clinical trials identified in the law, with the objective of enhancing patient enrollment and providing a mechanism for tracking subsequent progress of clinical trials, to the benefit of public health. The registry is widely used by patients, physicians, and medical researchers, in particular those involved in clinical research studies. Public Law 110-85 expands the scope of clinical trials that must be registered in ClinicalTrials.gov to include certain defined clinical trials of drugs, biologics, and devices subject to FDA regulation, regardless of whether they are related to serious or life-threatening diseases. It also increases the clinical trial information (i.e., number of data elements) that must be submitted as part of each registration. Frequency of Response: Responsible parties for applicable clinical trials must submit the required information shortly after the initiation of a trial [by the later of 21 days after the first patient is enrolled or December 26, 2007]. Updates to registration records are thereafter required at least once a year, unless there are no changes to report. Changes in recruitment status and completion of a trial must be reported not later than 30 days after such events. Records for trials that were ongoing (as defined in the Law) as of December 26, 2007 are also required to be updated to comply with the new registration data elements, even if they were previously registered. Description of Respondents: Respondents are referred to in the law as ``responsible parties.'' The statute defines the responsible party as: (1) The sponsor of the clinical trial (as defined in 21 CFR 50.3) or (2) the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, provided that ``the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements'' for submitting information under the law. Estimate of Burden: Under the clearance to date (OMB No. 0910- 0459), the FDA total hours burden was 200,839. The current annual reporting burden is shown in Table 1. It is estimated that approximately 3,500 applicable clinical trials of drugs and biologics and 445 applicable trials of devices will be registered annually in accordance with Public Law 110-85, Section 801. This estimate is based on FDA reports that in 2005 some 5,332 new clinical trial protocols were submitted to its Center for Drug Evaluation and Research and 474 new protocols were submitted to the Center for Biologics Evaluation and Research. FDA projects that rates of submission will remain at or near this level in the near future. An estimated 50% of the drug and biological protocols received in 2005, or approximately 2,900 protocols, were for trials involving assessments of effectiveness, which would be subject to the provisions of Title VIII of Public Law 110-85. This figure was raised to 3,500 drug and biological trials per year to account for IND-exempt trials that are required to register in the expanded registration data bank, but for which a protocol might not be sent to FDA. The estimated 445 new applicable device clinical trials per year includes trials related to pre-market applications (approximately 50 applications to FDA containing 75 clinical trial protocols in 2005), 510(k) submissions (approximately 360 submissions to FDA containing clinical trial protocols in 2005), and humanitarian device exemptions (9 in 2005). The estimates of drug, biologic, and device trials computed using this approach are consistent with the numbers of relevant trials that were registered with the ClinicalTrials.gov registry in calendar year 2007. The hour burden accounts for time required to register trials and provide necessary updating over the course of the study. Based on previous experience, it is estimated that each new registration record will be updated an average of 8 times during the course of the study (e.g., to reflect protocol changes, additions of investigational sites, updates of recruitment status, trial completion). The time to complete an initial (new) registration (for trials of drugs, biologics, or devices) is estimated to be 7 hours (including time to extract, reformat and submit information which has already been produced for other purposes), an increase of 50% above the 4.6 hours that was estimated by FDA for the smaller set of information collected under previous law. The time required for subsequent updates of this information is expected to be significantly less than for the original registration (as less information must be provided), and is estimated at 2 hours per update. Applying these figures to the anticipated numbers of trials produces a burden estimate for mandatory, new trial registrations of 90,735 hours.
Submission for OMB Review; Comment Request; Longitudinal Investigation of Fertility and the Environment
Document Number: E8-5700
Type: Notice
Date: 2008-03-21
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institutes of Health has submitted to the Office of Management and Budget (OMB) a request for renewal of an information collection request. The original information collection request was approved (OMB Clearance 0925-0543) following publication in the Federal Register on January 9, 2004, page 1589 and December 2, 2004, page 70153. The proposed collection extension was previously published in the Federal Register on January 16, 2008, page 2925 and allowed 60 days for public comment. Only one public comment was received during the previous comment period. It was received via e-mail from a concerned citizen who stated that she felt that the study should no longer continue because it is not a good use of tax dollars. 5 CFR 1320.5 (General Requirements) Reporting and Recordkeeping Requirements: Final Rule requires that the agency inform the potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number. This information is required to be stated in the 30-day Federal Register Notice. Proposed Collection: Title: Longitudinal Investigation of Fertility and the Environment (LIFE Study). Type of Information Collection Request: EXTENSION (OMB control number 0925-0543, expiration date, March 30, 2008). Need and Use of Information Collection: The purpose of the LIFE Study is to assess the impact of environmental factors, broadly defined to include lifestyle factors, on human reproduction and development. The LIFE Study is consistent with the mission of the Eunice Kennedy Shriver National Institute of Child Health and Human Development that includes conducting basic, clinical and epidemiologic research focusing on factors and processes associated with human reproduction and development thereby, ensuring the birth of healthy infants capable of reaching full adult potential unimpaired by physical or mental disabilities. This study will assess the relation between select environmental factors and human reproduction and development. This research originally proposed to recruit 960 couples who are interested in becoming pregnant and willing to participate in a longitudinal study. Fewer than expected couples were enrolled during the first three years of the project (n = 350), predominantly due to the fact that more couples were ineligible for participation than had been originally estimated. In light of this fact, the revised study plan is to enroll a total of 500 couples (i.e., 150 additional couples), a sample size that will not compromise the main study objectives. Couples will be selected from geographic regions that were chosen from peer reviewed competitive proposals. Fecundity will be measured by the time required for the couples to achieve pregnancy, while fertility will be measured by the ability of couples to have a live born infant. Infertility will be recognized for couples unable to conceive within 12 months of trying. The study's primary environmental exposures include: Organochlorine pesticides; polychlorinated biphenyls; polybrominated diphenyl ethers; metals; perfluorinated compounds; cotinine; and phytoestrogens. A growing body of literature suggests these compounds may exert adverse effects on human reproduction and development; however, definitive data are lacking especially for sensitive endpoints. Couples will participate in a 25- minute baseline interview and be instructed in the use of home fertility monitors and pregnancy kits for counting the time required for pregnancy and detecting pregnancy. Blood and urine samples will be collected at baseline from both partners of the couple for measurement of the environmental exposures. Two semen samples from male partners and two saliva samples from female partners also will be requested. Semen samples will be used to globally assess male fecundity as measured primarily by sperm concentration and morphology. Saliva samples will be used for the measurement of cortisol levels as a marker of stress among female partners so that the relation between environmental factors, stress and human reproduction can be assessed. The findings will provide valuable information regarding the effect of environmental contaminants on sensitive markers of human reproduction and development, filling critical data gaps. Moreover, these environmental exposures will be analyzed in the context of other lifestyle exposures such as use of cigarettes and alcohol, consistent with the manner in which human beings are exposed. Frequency of Response: Following the baseline interview (25 minutes), couples will each complete a 2-minute daily diary on select lifestyle factors. Women will perform daily fertility testing (7 minutes) approximately 11 days per cycle and pregnancy testing (4 minutes) at day of expected menses using a dipstick test in urine. Approximately 60% of women will become pregnant after 2 to 3 months, at which point they will switch to the less intensive portion of the protocol. Men will provide two semen samples, a month apart, requiring approximately 20 minutes for each collection, and women will collect two saliva samples, a month apart, requiring approximately 6 minutes each. Participating couples will be given a choice to submit their information by mail or to send it electronically to the Data Coordinating Center. This option will be available throughout data collection in the event couples change their minds about how they would like to submit information. Study participants will collect semen and saliva samples and forward them in prepaid delivery packages to the study's laboratories. Research nurses will collect blood and urine samples and return them to the study's laboratories. Affected Public: Individuals from participating communities. Type of Respondents: Men aged 18+ years and women aged 18-40 years. Estimated Number of Respondents: Approximately 500 couples enrolling (minimum of 400 completing the study). Estimated Number of Response Sets Per Respondent: 7 per woman and 4 per man over approximately two years. Average Burden Hours Per Response: (1) 0.17 hours for completing the screening instrument; (2) 0.42 hours for baseline interviews with men and women; (3) 2.5 hours for daily journal while attempting pregnancy for men and women; (4) 0.38 and 0.7 hours for biospecimen collection for women and men, respectively; (5) 2.6 hours for fertility monitors; (6) 0.27 hours for pregnancy testing for women; and (7) 0.29 hours for pregnancy journals for women. Estimated Total Annual Burden Hours Requested: 1,640 to 4,950 hours for female participants and 1,050 to 2,740 hours for male participants depending upon the length of time required for pregnancy. There is no cost to respondents. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov, or by fax to 202-395-6974, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. Germaine M. Buck Louis, Epidemiology Branch, Division of Epidemiology, Statistics & Prevention Research, NICHD, 6100 Executive Blvd., Room 7B03, Rockville, MD 20852, 301-496-6155. You may also e-mail your request to louisg@mail.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
Submission for OMB Review; Comment Request
Document Number: E8-5656
Type: Notice
Date: 2008-03-21
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Submission for OMB Review; Comment Request
Document Number: E8-5653
Type: Notice
Date: 2008-03-21
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: E8-5587
Type: Notice
Date: 2008-03-21
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: E8-5586
Type: Notice
Date: 2008-03-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Closed Meetings
Document Number: E8-5585
Type: Notice
Date: 2008-03-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Meeting
Document Number: E8-5584
Type: Notice
Date: 2008-03-21
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-5581
Type: Notice
Date: 2008-03-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-5579
Type: Notice
Date: 2008-03-21
Agency: Department of Health and Human Services, National Institutes of Health
Technologies for Prescription Drug Identification, Validation, Track and Trace, or Authentication; Request for Information
Document Number: E8-5599
Type: Notice
Date: 2008-03-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting comments and information regarding technologies used for the identification, validation, tracking and tracing, and authentication of prescription drugs. This request is related to FDA's implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA). Elsewhere in this issue of the Federal Register, FDA is publishing a related document entitled ``Standards for Standardized Numerical Identifier, Validation, Track and Trace, and Authentication for Prescription Drugs; Request for Comments.''
Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Solution
Document Number: E8-5598
Type: Rule
Date: 2008-03-20
Agency: Food and Drug Administration, Department of Health and Human Services
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 Norbrook Laboratories, Ltd. The supplemental NADA provides for changing scientific nomenclature for a bovine pathogen on labeling for 300 milligrams per milliliter (mg/mL) strength oxytetracycline injectable solution.
Standards for Standardized Numerical Identifier, Validation, Track and Trace, and Authentication for Prescription Drugs; Request for Comments
Document Number: E8-5597
Type: Notice
Date: 2008-03-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is seeking information and comments on issues related to standards for identification, validation, tracking and tracing, and authentication for prescription drug products. Particularly, we are requesting information and comments from drug manufacturers, distributors, pharmacies, other supply chain stakeholders, foreign regulators, standards organizations, and other Federal agencies and interested parties. This request is related to FDA's implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA). Elsewhere in this issue of the Federal Register, FDA is publishing a related document entitled ``Technologies for Prescription Drug Identification, Validation, Track and Trace, or Authentication; Request for Information.''
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-5570
Type: Notice
Date: 2008-03-20
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
National Eye Institute; Notice of Closed Meetings
Document Number: E8-5568
Type: Notice
Date: 2008-03-20
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Extension of Certification on Maintenance of Effort for the Title III and Certification of Long-Term Care Ombudsman Program Expenditures
Document Number: E8-5514
Type: Notice
Date: 2008-03-19
Agency: Aging Administration, Department of Health and Human Services
The Administration on Aging (AoA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to the Certification on Maintenance of Effort for the Title III and Certification of Long-Term Care Ombudsman Program Expenditures for all AoA Title III and Title VII Grantees.