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

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (181) entitled ``Blue Bird Medicated Feed Labels.'' This guidance provides new animal drug application (NADA) sponsors with the Center for Veterinary Medicine's current thinking on what constitutes recommended content and format of representative labels for new animal drugs intended for use in the manufacture of medicated feeds.

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Intervet Inc. The NADA provides for use of approved, single-ingredient Type A medicated articles containing zilpaterol hydrochloride, monensin USP, tylosin phosphate, and melengestrol acetate in four-way combination Type B and Type C medicated feeds for heifers fed in confinement for slaughter.

This notice announces the availability of seven updated final toxicological profiles of priority hazardous substances. This is the 19th set of toxicological profiles that ATSDR has compiled.

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 reporting and recordkeeping requirements for ``New Animal Drugs for Investigational Use.''

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award approximately $996,000 (total costs) per year for up to two years to the Education Development Resource Center, Inc. Newton, Massachusetts. This is not a formal request for applications. Assistance will be provided only to the Education Development Resource Center, Inc. based on the receipt of a satisfactory application that is approved by an independent review group. Funding Opportunity Title: SM-08-014 Catalog of Federal Domestic Assistance (CFDA) Number: 93.243

The Food and Drug Administration (FDA) is withdrawing a direct final rule that published in the Federal Register of December 4, 2007 (72 FR 68064), to amend certain regulations as the first phase of an incremental approach to modernize or clarify some of the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, as well as harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations. The comment period closed February 19, 2008. FDA is withdrawing the direct final rule because the agency received significant adverse comments. FDA will consider the comments received under our usual procedures for notice and comment in connection with the notice of proposed rulemaking that was published in the Federal Register of December 4, 2007, as a companion to the direct final rule (72 FR 68113).

At the request of the U.S. Environmental Protection Agency (EPA), the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) is planning to assess the validation status of a proposed non-animal approach for evaluating the eye irritation potential of AMCPs that meets hazard classification and labeling requirements. On behalf of ICCVAM, NICEATM requests: 1. Nominations of expert scientists to serve as members of an independent peer review panel. 2. Submission of relevant data and information on AMCPs or related substances obtained from (1) human testing or experience including reports from accidental exposures, (2) rabbits using the standard eye test or the low volume eye test (LVET), and (3) in vitro test methods for assessing ocular irritation, such as the Bovine Corneal Opacity and Permeability (BCOP) test, the Cytosensor Microphysiometer (CM) test, and the EpiOcular test, and data supporting the accuracy and reproducibility of these methods.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Division of Loan Repayment, 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 26, 2007, and allowed 60 days for public comment. No responses to the notice were received. The purpose of this notice is to allow an additional 30 days for public comment. 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.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Assessment of the Emergency Severity Index (ESI).'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on January 22nd, 2008 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

This final rule changes the weighting methodology used to calculate the low-income benchmark premium amount (benchmark) for 2009 and thereafter. Under this final rule, the benchmark weighting methodology is adjusted so that the relative weights of the Medicare Advantage Prescription Drug (MA-PD) plan premiums and Prescription Drug Plan (PDP) plan premiums in the low-income benchmark premium amount reflect the distribution of enrollment of beneficiaries eligible for the low-income subsidy in each plan.

The Food and Drug Administration (FDA) has determined the regulatory review period for ACRYSOF and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device.

The Food and Drug Administration (FDA) is requesting comments on the use of third-party certification programs for foods and feeds, including pet foods. An increasing number of firms that sell foods to the public, such as retailers and food service providers, are requesting that their suppliers become certified as meeting food (and feed) safety and quality standards as a condition of doing business. FDA seeks more information on the existence and use of these types of programs to better understand how they can help to ensure that food products are safe, secure, and meet FDA requirements.

This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MedCAC) (``Committee'') will be held on Wednesday, May 21, 2008. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services are reasonable and necessary under the Medicare statute. This meeting will focus on the design and methodological issues that challenge clinical research regarding innovative neurorehabilitation techniques. The meeting will discuss the various kinds of evidence that are useful to support requests for Medicare coverage in this field. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October 2007 through December 2007, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. This notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations and a list of Medicare-approved carotid stent facilities. Included in this notice is a list of the American College of Cardiology's National Cardiovascular Data registry sites, active CMS coverage-related guidance documents, and special one-time notices regarding national coverage provisions. Also included in this notice is a list of National Oncologic Positron Emissions Tomography Registry sites, a list of Medicare-approved ventricular assist device (destination therapy) facilities, a list of Medicare-approved lung volume reduction surgery facilities, a list of Medicare-approved clinical trials for fluorodeoxyglucose positron emissions tomogrogphy for dementia, and a list of Medicare-approved bariatric surgery facilities. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame.

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 IVX Animal Health, Inc. The supplemental NADA provides for changing scientific nomenclature for a bovine pathogen on labeling for penicillin G benzathine and penicillin G procaine injectable suspension.

With this notice, the National Institutes of Health (NIH) of the U.S. Department of Health and Human Services (HHS) requests input from the community regarding the NIH Policy on Enhancing Public Access to Archived Publications Resulting From NIH-Funded Research (NIH Public Access Policy). Complete and detailed information about the law at Division G, Title II, section 218 of Public Law 110-161 (Consolidated Appropriations Act, 2008), the NIH Public Access Policy, and implementation procedures issued to date are available at https:// publicaccess.nih.gov/index.htm. This request for information (RFI) seeks input on the Public Access Policy as described on the above Web site. This RFI will be active from March 31, 2008 to May 31, 2008 on https://publicaccess.nih.gov/comments.htm. The NIH will post analysis and results from this RFI for public view onto https:// publicaccess.nih.gov by September 30, 2008. Background: The National Institutes of Health (NIH)The Nation's Medical Research Agencyis comprised of 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary Federal agency for conducting and supporting basic, clinical, and translational medical research, and investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit https://www.nih.gov. PubMed Central is an archive of full-text biomedical journal articles available online without a fee. Articles on PubMed Central contain links to other scientific databases such as GenBank (https:// www.ncbi.nlm.nih.gov/ Genbank/) and PubChem (https:// pubchem.ncbi.nlm.nih.gov/). Articles collected under the Public Access Policy are archived on PubMed Central. More information about PubMed Central is available at https://www.pubmedcentral.nih.gov/about/ faq.html. Prior to the Consolidated Appropriations Act of 2008, NIH's voluntary Public Access Policy (NOT-OD-05-022 available at https:// grants.nih.gov/grants/guide/notice-files/NOT-OD-05-022.html and in the section on SUPPLEMENTARY INFORMATION) encouraged but did not require those receiving NIH funding to deposit their peer reviewed manuscripts into PubMed Central. Division G, Title II, section 218 of Public Law 110-161 (Consolidated Appropriations Act of 2008) states:

The Department of Health and Human Services (DHHS) is hereby giving notice that the National Vaccine Program Office (NVPO) will convene a meeting of the Vaccine Finance Working Group and is inviting input from stakeholders on this issue. The meeting will be open to the public.

On Tuesday, May 16, 2006, CDC published draft criteria for removing chemicals from future releases of CDC's National Report on Human Exposure to Environmental Chemicals (the ``Report'') (See FR, Vol. 71, No. 94, p. 28346-7). This and previous notices related to the ``Report'' are at https://www.cdc.gov/exposurereport/chemical_ nominations.htm. The proposed criteria provided that a chemical may be removed from the ``Report'' if (1) a new replacement chemical (i.e., a metabolite) is more representative of exposure than is the chemical currently measured; or (2) after three survey periods (or not less than 6 years), detection rates for all chemicals within a methodological and chemically related group are less than 5 percent for all population subgroups (i.e., two sexes, three race/ethnicity groups, and three age groups); or (3) after three survey periods (or not less than 6 years), levels of chemicals within a methodological and chemically related group are unchanged or declining in all the specific subgroups as documented in the ``Report.'' Using these criteria, CDC would have continued to measure the chemical and not remove it from the ``Report'' if it met either of two proposed exceptions to these criteria: (a) It is a chemical for which there is an established biomonitoring threshold (e.g., CDC's level of concern for blood lead levels in children) or any chemical for which there is widespread public health concern (e.g., mercury) or (b) three survey periods (or not less than 6 years) have passed, constituting the minimum time before a chemical could be removed; a longer period may be necessary to account for the half-life of a particular chemical or to account for a recent change (e.g., the removal of a chemical from commerce) that would necessitate monitoring of the population. In that notice, CDC pointed out that the criteria for removing a chemical from the ``Report'' are not corollaries of the criteria for adding chemicals to the ``Report.''

This final notice announces our decision to approve the Community Health Accreditation Program (CHAP) for recognition as a national accreditation program for home health agencies (HHAs) seeking to participate in the Medicare or Medicaid programs.

The Food and Drug Administration (FDA) is issuing this notice to notify holders of certain prescription new drug and biological license applications that they will be deemed to have in effect an approved risk evaluation and mitigation strategy (REMS) under the Food and Drug Administration Amendments Act of 2007 (FDAAA). Holders of applications deemed to have in effect an approved REMS are required to submit a proposed REMS to FDA.

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.

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.

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.

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.

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.

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.

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 https:// 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.

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.

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.

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).

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.

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.''

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.''