Notices. Notice

5,319 words·~24 min read·/register/2007/05/31/07-2698

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4160-90-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel: Occupational Health and Safety Research Member Conflict, Program Announcement

(PA)04-038 In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announces a meeting of the aforementioned Special Emphasis Panel. *Time and Date:* 1 p.m.-4 p.m., July 12, 2007 (Closed). *Place:* Teleconference. *Status:* The meeting will be closed to the public in accordance with provisions set forth in section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters To Be Discussed:* The meeting will include the review, discussion, and evaluation of research grant applications in response to “Occupational Health and Safety Research Member Conflict,” PA 04-038. *Contact Person for More Information:* George Bockosh, Scientific Review Administrator, 625 Cochrans Mill Road, Mailstop P-05, Pittsburgh, PA 15222, telephone

(412)386-6465. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: May 24, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-10421 Filed 5-30-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel: Applied Research in Antimicrobial Resistance: Studies of Susceptibility Testing on Gram-negative Multidrug Resistant Organisms, Funding Opportunity Announcement

(FOA)CI07-003 In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announces a meeting of the aforementioned Special Emphasis Panel. *Time and Date:* 12 p.m.-4 p.m., June 28, 2007 (Closed). *Place:* Teleconference. *Status:* The meeting will be closed to the public in accordance with provisions set forth in section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters to be Discussed:* The meeting will include the review, discussion, and evaluation of research grant applications in response to FOA CI07-003, “Applied Research in Antimicrobial Resistance: Studies of Susceptibility Testing on Gram-negative Multidrug Resistant Organisms.” *Contact Person for More Information:* Trudy Messmer, PhD, Scientific Review Administrator, 1600 Clifton Road, Mailstop C-19, Atlanta, GA 30333, telephone

(404)639-2176. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: May 24, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-10422 Filed 5-30-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel: Travelers' Health Research Centers—Evaluation of Measures To Protect the Health of International Travelers, Funding Opportunity Announcement

(FOA)CI07-002 In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announces a meeting of the aforementioned Special Emphasis Panel. *Time and Date:* 12 p.m.-4 p.m., June 29, 2007 (Closed). *Place:* Teleconference. *Status:* The meeting will be closed to the public in accordance with provisions set forth in section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters to be Discussed:* The meeting will include the review, discussion, and evaluation of research grant applications in response to FOA CI07-002, “Travelers” Health Research Centers—Evaluation of Measures To Protect the Health of International Travelers.” *Contact Person for More Information:* Trudy Messmer, PhD, Scientific Review Administrator, 1600 Clifton Road, Mailstop C-19, Atlanta, GA 30333, telephone

(404)639-2176. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: May 24, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-10433 Filed 5-30-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel: Racial and Ethnic Approaches to Community Health Across the United States (REACH US), Request for Applications

(RFA)DP07-707 In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announces a meeting of the aforementioned Special Emphasis Panel. *Times and Dates:* 8 a.m.-5 p.m., June 18, 2007 (Closed). 8 a.m.-5 p.m., June 19, 2007 (Closed). 8 a.m.-5 p.m., June 20, 2007 (Closed). 8 a.m.-5 p.m., June 21, 2007 (Closed). 8 a.m.-5 p.m., June 22, 2007 (Closed). *Place:* Atlanta Marriott Century Center Hotel, 2000 Century Boulevard, NE., Atlanta, GA 30345, Telephone

(404)325-0000. *Status:* The meeting will be closed to the public in accordance with provisions set forth in section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters To Be Discussed:* The meeting will include the review, discussion, and evaluation of research grant applications in response to RFA DP07-707, “Racial and Ethnic Approaches to Community Health Across the United States (REACH US).” *Contact Person for More Information:* Thijuanie Lockhart, Program & Management Analyst, CDC, 4770 Buford Highway, NE., Mail Stop K-30, Atlanta, GA 30341, Telephone

(404)488-5303. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: May 24, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-10434 Filed 5-30-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel: Improving Public Health Practice Through Translation Research, Request for Applications

(RFA)CD07-005 In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announces a meeting of the aforementioned Special Emphasis Panel. *Times and Dates:* 9 a.m.-5 p.m., June 25, 2007 (Closed). 9 a.m.-5 p.m., June 26, 2007 (Closed). *Place:* Doubletree Buckhead Hotel, 3342 Peachtree Road, N.E., Atlanta, GA 30326. *Status:* The meeting will be closed to the public in accordance with provisions set forth in section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters To Be Discussed:* The meeting will include the review, discussion, and evaluation of the scientific merit of research applications in response to RFA CD07-005, “Improving Public Health Practice Through Translation Research.” *Contact Person for More Information:* Christine J. Morrison, PhD, Scientific Review Administrator, 1600 Clifton Road, NE., Mailstop D72, Atlanta, GA 30333, telephone

(404)639-3098. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: May 24, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-10436 Filed 5-30-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 1999D-1651] (formerly Docket No. 99D-1651) Guidance for Industry: Chemistry, Manufacturing, and Control Changes to an Approved New Animal Drug Application or Abbreviated New Animal Drug Application AGENCY: Food and Drug Administration. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a guidance for industry (#83) entitled “Chemistry, Manufacturing, and Control Changes to an Approved NADA or ANADA.” This guidance is intended to provide recommendations to holders of new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) on how they should report certain changes to such applications, in accordance with the final regulation, 21 CFR 514.8, which was issued in the **Federal Register** of December 13, 2006 (71 FR 74766). DATES: Comments on agency guidances are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit written comments on the guidance document to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Dennis Bensley, Jr., Center for Veterinary Medicine (HFV-140), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-6956, e-mail: *dennis.bensley@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** of October 1, 1999 (64 FR 53281), FDA published a proposed rule to implement section 506A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356a) for NADAs and ANDAs. In that same issue of the **Federal Register** (64 FR 53393), FDA published a notice announcing the availability of a draft guidance for industry entitled “Chemistry, Manufacturing, and Control Changes to an Approved NADA or ANADA,” giving interested persons until December 15, 1999, to submit comments. FDA considered all comments received and, where appropriate, incorporated them into the guidance. This guidance covers recommended reporting categories for various postapproval manufacturing changes and provides recommendations to holders of NADAs and ANADAs on how they should report such changes in accordance with the final regulation, 21 CFR 514.8, issued in the **Federal Register** of December 13, 2006 (71 FR 74766). Recommendations are provided for postapproval changes in:

(1)Components and composition,

(2)manufacturing sites,

(3)manufacturing process,

(4)specifications,

(5)container closure system, as well as

(6)miscellaneous changes and

(7)multiple related changes. This guidance does not provide recommendations on the specific information that should be developed by an applicant to assess the effect of the change on the identity, strength (e.g., assay, content uniformity), quality (e.g., physical, chemical, and biological properties), purity (e.g., impurities and degradation products), or potency (e.g., biological activity, bioavailability, bioequivalence) of a drug as these factors may relate to the safety or effectiveness of the drug. An applicant should consider all relevant FDA guidance documents for recommendations on the information that should be submitted to support a given change. II. Significance of Guidance This level 1 guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This guidance represents the agency's current thinking on the topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative method may be used as long as it satisfies the requirements of applicable statutes and regulations. III. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in sections II through XI of the guidance have been approved under OMB Control No. 0910-0600. IV. Comments As with all of FDA's guidance, the public is encouraged to submit written or electronic comments with new data or other new information pertinent to this guidance. FDA periodically will review the comments in the docket and, where appropriate, will amend the guidance. The agency will notify the public of any such amendments through a notice in the **Federal Register** . Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments should be identified with the full title of the guidance document and the docket number found in brackets in the heading of this document. A copy of the document and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. V. Electronic Access Persons with access to the Internet may obtain a copy of the guidance document entitled “Chemistry, Manufacturing and Control Changes to an Approved NADA or ANADA” from the CVM home page at *http://www.fda.gov/cvm* . Dated: May 22, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-10515 Filed 5-30-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0168] Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: This notice announces the availability of draft guidances for industry that describe recommendations on how to design bioequivalence

(BE)studies for 200 specific drug products to support abbreviated new drug applications (ANDAs). These draft guidances are being made available concurrently with the publication of a draft guidance for industry entitled “Draft Guidance for Industry—Bioequivalence Recommendations for Specific Products” (product specific BE recommendations). This draft guidance describes the new process for making available guidance on product-specific BE studies. Under the process described in the draft guidance, draft and final product-specific BE study guidance will be made available on the FDA Web site. FDA believes that making this information available on the Internet will streamline the guidance process and provide a meaningful opportunity for the public to consider and comment on product-specific BE study recommendations. Elsewhere in this issue of the **Federal Register** , FDA is announcing the availability of a related guidance document entitled “Draft Guidance for Industry—Bioequivalence Recommendations for Specific Products.” DATES: Submit written or electronic comments on the draft guidances by September 28, 2007. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of draft product-specific BE study guidances to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Doan T. Nguyen, Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0495. SUPPLEMENTARY INFORMATION: I. Background To receive approval for an ANDA, an applicant generally must demonstrate, among other things, that its product has the same active ingredient, dosage form, strength, route of administration and conditions of use as the listed drug, and that the proposed drug product is bioequivalent to the reference listed drug (21 U.S.C. 355(j)(2)(A); 21 CFR 314.94(a)). Bioequivalent drug products show no significant difference in the rate and extent of absorption of the therapeutic ingredient (21 U.S.C. 355(j)(8); 21 CFR 320.1(e)). BE studies are undertaken in support of ANDA submissions with the goal of demonstrating BE between a proposed generic drug product and its reference listed drug. The regulations governing BE are provided at 21 CFR in part 320. The draft guidance entitled “Bioequivalence Recommendations for Specific Products” describes the following process for making available draft and final product-specific BE recommendations: • FDA will develop product-specific BE recommendations and post them on the Center for Drug Evaluation and Research

(CDER)guidance page ( *http://www.fda.gov/cder/index.html* ) in draft to facilitate public consideration and comment. The recommendations can be viewed by clicking on the URL associated with the “Bioequivalence Recommendations for Specific Products” guidance on the CDER guidance page or on the Office of Generic Drugs Page (see *www.fda.gov/cder/ogd/index.htm* ). Users can also search for a specific product BE recommendation using the search tool on the CDER guidance page. • Newly posted draft and final BE recommendations will be announced in the “Newly Added Guidance Documents” list, which is posted monthly on the CDER guidance page. • The agency will issue a notice in the **Federal Register** announcing the availability on the FDA web site of new product-specific draft and final BE recommendations. The notice will identify a comment period for the recommendations. • Comments on product-specific BE recommendations will be considered in developing final BE recommendations. • The BE recommendations will be revised as appropriate to ensure that the most up-to-date BE information is available to the public. FDA is making the first group of draft product-specific BE recommendations available concurrently with the issuance of the draft guidance document describing the process. II. Drug Products for Which Draft Product-Specific BE Recommendations Are Available The FDA is making available draft recommendations for drug products containing the following active ingredients: A Abacavir Sulfate Abacavir Sulfate; Lamivudine; Zidovudine Acamprosate Calcium Acitretin Acyclovir Almotriptan Malate Alosetron HCl Alprazolam Amlodipine Besylate Amlodipine Besylate; Benazepril HCl Amoxicillin; Clavulanate Potassium Anagrelide HCl Anastrozole Aprepitant Atazanavir Sulfate Atomoxetine HCl Atorvastatin Calcium B Benzonatate Benzphetamine HCl Bicalutamide Bisoprolol Fumarate Bisoprolol Fumarate; Hydrochlorothiazide C Candesartan Cilexetil Candesartan Cilexetil; Hydrochlorothiazide Carbamazepine Carbidopa; Entacapone; Levodopa Carvedilol Cefditoren Pivoxil Celecoxib Cetirizine HCl Cevimeline HCl Cilostazol Cinacalcet HCl Clarithromycin Clonidine HCl Clopidogrel D Danazol Dantrolene Sodium Darifenacin HBr Deferasirox Desloratadine Dextromethorphan Polistirex Diclofenac Sodium; Misoprostol Dicloxacillin Sodium Didanosine (multiple dosage forms) Digoxin Dipyridamole Divalproex Sodium Dofetilide Donepezil HCl Doxazosin Mesylate Drospirenone; Estradiol Duloxetine HCl (multiple dosage forms) Dutasteride E Efavirenz (multiple dosage forms) Emtricitabine Entacapone Entecavir Eplerenone Erlotinib HCl Escitalopram Oxalate Esomeprazole Magnesium Etidronate Disodium Exemestane F Famotidine (multiple dosage forms) Felbamate (multiple dosage forms) Fenofibrate Fexofenadine HCl (multiple dosage forms) Flavoxate HCl Fluconazole Fluoxetine HCl; Olanzapine Fosamprenavir Calcium Fosinopril Sodium; Hydrochlorothiazide G Gabapentin (multiple dosage forms) Galantamine HBr Ganciclovir Gemifloxacin Mesylate Glimepiride Glipizide; Metformin HCl Glyburide; Metformin HCl Granisetron HCl H Hydrochlorothiazide Hydrochlorothiazide; Lisinopril Hydrochlorothiazide; Losartan Potassium Hydrochlorothiazide; Moexipril HCl Hydrochlorothiazide; Olmesartan Medoxomil Hydrochlorothiazide; Valsartan I Ibandronate Sodium Ibuprofen; Pseudoephedrine HCl Indinavir Sulfate Irbesartan Isosorbide Mononitrate Isradipine (multiple dosage forms) Itraconazole L Lamivudine Lamivudine; Zidovudine Lamotrigine (multiple dosage forms) Leflunomide Liothyronine Sodium Losartan Potassium M Mefloquine HCl Meloxicam (multiple dosage forms) Mercaptopurine Mesalamine Metaxalone Metformin HCl Metformin HCl; Pioglitazone HCl Miglustat Mirtazapine Modafinil Moexipril HCl Montelukast Sodium Morphine Sulfate Mycophenolate Mofetil Mycophenolate Mofetil HCl N Nabumetone Nateglinide Nelfinavir Mesylate Nevirapine O Olanzapine Olmesartan Medoxomil Olsalazine Sodium Omeprazole (multiple dosage forms) Omeprazole Magnesium Ondansetron (multiple dosage forms) Oxcarbazepine (multiple dosage forms) P Pantoprazole Sodium Perindopril Erbumine Pilocarpine HCl Pravastatin Sodium Q Quetiapine Fumarate Quinapril HCl R Raloxifene HCl Ramipril Ribavirin (multiple dosage forms) Rifampin Riluzole Risedronate Sodium; Calcium Chloride Risedronate Sodium Risperidone Ritonavir Rizatriptan Benzoate Rosiglitazone Maleate Rosuvastatin Calcium S Sertraline HCl Sibutramine HCl Sildenafil Citrate Simvastatin Sirolimus Stavudine Sulfamethoxazole; Trimethoprim Sumatriptan Succinate T Tacrolimus Tadalafil Tamsulosin HCl Telithromycin Telmisartan Terbinafine HCl Testosterone Ticlopidine HCl Tizanidine HCl Tolterodine Tartrate Topiramate (multiple dosage forms) Torsemide Tramadol HCl Tramadol HCl; Acetaminophen Trandolapril Triamterene V Valacyclovir HCl Valsartan Vardenafil HCl Venlafaxine HCl Verapamil HCl (multiple dosage forms) Voriconazole Z Zaleplon Zidovudine (multiple dosage forms) Ziprasidone HCl Zolpidem Tartrate These draft guidances are available on the CDER guidance page and may be viewed by clicking on the URL associated with the draft “Bioequivalence Recommendations for Specific Products” guidance on the CDER guidance page or on the Office of Generic Drugs Page (see *www.fda.gov/cder/ogd/index.htm* ). Users can also search for a specific product BE recommendation using the search tool on the CDER guidance page. These draft guidances are being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidances represent the agency's current thinking on the design of product-specific bioequivalence studies to support ANDAs. Guidance does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments on the draft guidance. Two copies of mailed comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The draft guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IV. Electronic Access Persons with access to the Internet may obtain the draft product-specific BE recommendations at either *http://www.fda.gov/cder/guidance/index.htm* or *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: May 22, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-10491 Filed 5-30-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0169] Draft Guidance for Industry on Bioequivalence Recommendations for Specific Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a draft guidance for industry entitled “Bioequivalence Recommendations for Specific Products” that describes a new process for making available recommendations on how to design product-specific bioequivalence

(BE)studies to support abbreviated new drug applications (ANDAs). Under this process, applicants planning to carry out such studies in support of their ANDAs will be able to access BE study guidance on the FDA Web site. FDA believes that making this information available on the Internet will streamline the guidance process and will provide a meaningful opportunity for the public to consider and comment on product-specific BE study recommendations. Elsewhere in this issue of the **Federal Register** , FDA is announcing the availability of the first group of draft product-specific BE recommendations. DATES: Submit written or electronic comments on the draft guidance by August 29, 2007. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Doan T. Nguyen, Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0495. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled “Bioequivalence Recommendations for Specific Products.” To receive approval for an ANDA, an applicant generally must demonstrate, among other things, that its product has the same active ingredient, dosage form, strength, route of administration and conditions of use as the listed drug, and that the proposed drug product is bioequivalent to the reference listed drug (21 U.S.C. 355(j)(2)(A); 21 CFR 314.94(a)). Bioequivalent drug products show no significant difference in the rate and extent of absorption of the therapeutic ingredient (21 U.S.C. 355(j)(8); 21 CFR 320.1(e)). BE studies are undertaken in support of ANDA submissions with the goal of demonstrating BE between a proposed generic drug product and its reference listed drug. The regulations governing BE are provided at 21 CFR in part 320. Previously, the Office of Generic Drugs

(OGD)has provided information on how to design BE studies for specific products only when asked for assistance by individual applicants. In most cases, the requested information was not available anywhere else, and, in some cases, OGD performed its own research before responding to an applicant's request for information. In many cases, FDA responded to individual applicants in letter format after specific recommendations were prepared by individuals within the Center for Drug Evaluation and Research (CDER). With the increasing number of both ANDA submissions and requests for BE information during the last few years, this approach has become inefficient and extremely time consuming for the agency. As a result, after exploring various mechanisms that would allow us to conserve our resources while responding to the needs of industry and other interested persons, OGD has developed a new approach to making guidance available on product-specific BE studies. As before, BE recommendations will be developed by the agency based on its understanding of the characteristics of the listed drug, information derived from published literature, agency research, and consultations within different offices in CDER as needed based upon the novelty or complexity of the BE considerations. FDA proposes that, once drafted, product-specific BE recommendations will be made available through the process described in the guidance. II. Procedures for Making BE Recommendations Available To streamline the process for making guidance available to the public on how to design product-specific BE studies, the agency intends to use the following process: • Product-specific BE recommendations will be developed and posted on the CDER guidance page at *http://www.fda.gov/cder/index.html* in draft to facilitate public consideration and comment. • The recommendations can be viewed by clicking on the URL associated with this guidance on the CDER guidance page ( *http://www.fda.gov/cder/index.html* ) or on the OGD page (see *www.fda.gov/cder/ogd/index.htm* ). Users can also search for a specific product BE recommendation using the search tool on the guidance page. • Newly posted draft and final BE recommendations will be announced in the New/Revised/Withdrawn list, which is posted monthly on the CDER guidance page. • The agency will issue a notice in the **Federal Register** announcing the availability on the FDA Web site of new product-specific draft and final BE recommendations. The notice will identify a comment period for the recommendations. • Comments on product-specific BE recommendations will be considered in developing final BE recommendations. • The BE recommendations will be revised as appropriate to ensure that the most up-to-date BE information is available to the public. FDA has decided to make the first group of BE recommendations available concurrently with the issuance of this draft guidance document. A notice of availability of the first group of draft product-specific BE recommendations is also being published today. It includes a list of the drug products for which draft BE recommendations are available. Comments on the product-specific draft guidances are requested within 120 days. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on a new process for making available to sponsors FDA guidance on how to design product-specific bioequivalence studies to support ANDAs. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IV. Electronic Access Persons with access to the Internet may obtain the document at either *http://www.fda.gov/cder/guidance/index.htm* or *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: May 22, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-10492 Filed 5-30-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; Comment Request; The Jackson Heart Study

(JHS)*Summary:* Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health

(NIH)has submitted to the Office of Management and Budget

(OMB)a request for review and approval the information collection listed below. This proposed information collection was previously published in the **Federal Register** on October 25, 2006, pages 62476-62477, 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. 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:* The Jackson Heart Study (JHS). *Type of Information Collection Request:* Extension of a currently approved collection (OMB NO. 0925-0491). *Need and Use of Information Collection:* This project involves annual follow-up by telephone of participants in the JHS, review of their medical records, and interviews with doctors and family to identify disease occurrence. Interviewers will contact doctors and hospitals to ascertain participants' cardiovascular events. Information gathered will be used to further describe the risk factors, occurrence rates, and consequences of cardiovascular disease in African American men and women. *Frequency of Response:* One time. *Affected Public:* Individuals or households; Businesses or other for profit; Small businesses or organizations. *Type of Respondents:* Individuals or households; Businesses or other for profit; not-for-profit institutions. The annual reporting burden is as follows: *Estimated Number of Respondents:* 600; *Estimated Number of Responses per Respondent:* 1.0; *Average Burden Hours Per Response:* 0.5 and *Estimated Total Annual Burden Hours Requested:* 300. The annualized cost to respondents is estimated at $9,500. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Estimate of Annual Hour Burden Type of response Number of respondents Frequency of response Average time per response Annual hour burden Morbidity & Mortality AFU 3rd Party/Next-of-kin decedents 300 1 0.5 150 Morbidity & Mortality AFU 3rd Party Physicians 300 1 0.5 150 Total 600 300 *Request for Comments:* Written comments and/or suggestions from the public and affected agencies should address 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, New Executive Office Building, Room 10235, Washington, DC 20503, 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: Ms. Cheryl Nelson, Project Officer, NIH, NHLBI, 6701 Rockledge Drive, MSC 7934, Bethesda, MD 20892-7934, or call non-toll-free number 301-435-0451 or E-mail your request, including your address to: *NelsonC@nhlbi.nih.go* v. *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. Dated: May 22, 2007. Peter Savage, Acting Director. Dated: May 22, 2007. Suzanne A. Freeman, Project Clearance Officer. [FR Doc. 07-2698 Filed 5-30-07; 8:45 am]

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