Notices. Notice

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BILLING CODE 4140-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0485] Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Food and Drug Administration Approval to Market a New Drug AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: 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 governing applications for FDA approval to market a new drug. DATES: Submit written or electronic comments on the collection of information by March 4, 2008. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* or *http://www.regulations.gov.* Submit written comments on the collection of information to the Division of Dockets Management (HFA 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Karen L. Nelson,Office of the Chief Information Officer (HFA 250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4816. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Application for FDA Approval to Market a New Drug—(OMB Control Number 0910-0001)—Extension Under section 505(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(a)), a new drug may not be commercially marketed in the United States, imported, or exported from the United States, unless an approval of an application filed with FDA under section 505(b) or 505(j) of the act is effective with respect to such drug. Under the act, it is the sponsor's responsibility to provide the information needed by FDA to make a scientific and technical determination whether the product is safe and effective for use. This information collection approval request is for all information requirements imposed on sponsors by the regulations under part 314 (21 CFR part 314), who apply for approval of a new drug application

(NDA)or abbreviated new drug application

(ANDA)in order to market or to continue to market a drug. Section 314.50(a) requires that an application form (Form FDA 356h) be submitted that includes introductory information about the drug as well as a checklist of enclosures. Section 314.50(b) requires that an index be submitted with the archival copy of the application and that it reference certain sections of the application. Section 314.50(c) requires that a summary of the application be submitted that presents a good general synopsis of all the technical sections and other information in the application. Section 314.50(d) requires that the NDA contain the following technical sections about the new drug: Chemistry, manufacturing, and controls; nonclinical pharmacology and toxicology; human pharmacokinetics and bioavailability; microbiology; clinical data; and statistical section. Section 314.50(e) requires the applicant to submit samples of the drug if requested by FDA. In addition, the archival copy of the application must include copies of the label and all labeling for the drug. Section 314.50(f) requires that case report forms and tabulations be submitted with the archival copy. Section 314.50(h) requires that patent information, as described under § 314.53, be submitted with the application. (The burden hours for § 314.50(h) are already approved by OMB under OMB control number 0910-0513 and are not included in the burden estimates in table 1 of this document.) Section 314.50(i) requires that patent certification information be submitted in section 505(b)(2) applications for patents claiming the drug, drug product, or method of use. Section 314.50(j) requires that applicants that request a period of marketing exclusivity submit certain information with the application. Section 314.50(k) requires that an archival, review, and field copy of the application be submitted. Section 314.52 requires that any notice of certification of invalidity or noninfringement of a patent to each patent owner and the NDA holder be sent by a section 505(b)(2) applicant that relies on a listed drug. A 505(b)(2) applicant is required to amend its application at the time notice is provided to include a statement certifying that the required notice has been provided. A 505(b)(2) applicant also is required to amend its application to document receipt of the required notice. Section 314.54 sets forth the content requirements for applications filed under section 505(b)(2) of the act. (The information collection burden estimate for 505(b)(2) applications is included in table 1 of this document under the estimates for § 314.50(a), (b), (c), (d), (e), (f), and (k)). Section 314.60 sets forth reporting requirements for sponsors who amend an unapproved application. Section 314.65 states that the sponsor must notify FDA when withdrawing an unapproved application. Sections 314.70 and 314.71 require that supplements be submitted to FDA for certain changes to an approved application. Section 314.72 requires sponsors to report to FDA any transfer of ownership of an application. Section 314.80(c)(1) and (c)(2) sets forth requirements for expedited adverse drug experience postmarketing reports and followup reports, as well as for periodic adverse drug experience postmarketing reports (Form FDA 3500A). (The burden hours for § 314.80(c)(1) and (c)(2) are already approved by OMB under OMB control numbers 0910-0230 and 0910-0291 and are not included in the burden estimates in table 1 of this document.) Section 314.80(i) establishes recordkeeping requirements for reports of postmarketing adverse drug experiences. (The burden hours for § 314.80(i) are already approved by OMB under OMB control numbers 0910-0230 and 0910-0291 and are not included in the burden estimates in table 1 of this document.) Section 314.81(b)(1) requires that field alert reports be submitted to FDA (Form FDA 3331). Section 314.81(b)(2) requires that annual reports be submitted to FDA (Form FDA 2252). Section 314.81(b)(3)(i) requires that drug advertisements and promotional labeling be submitted to FDA (Form FDA 2253). Form FDA 2253 has been revised by FDA as follows: On line 8, “Please check one or both” has been revised to read “Please check only one.” In the instruction for line 8, the sentence “Consumer and professional pieces should be submitted separately” has been added. Section 314.81(b)(3)(iii) sets forth reporting requirements for sponsors who withdraw an approved drug product from sale. (The burden hours for § 314.81(b)(3)(iii) are already approved by OMB under OMB control number 0910-0045 and are not included in the burden estimates in table 1 of this document.) Section 314.90 sets forth requirements for sponsors who request waivers from FDA for compliance with §§ 314.50 through 314.81. (The information collection burden estimate for NDA waiver requests is included in table 1 of this document under estimates for §§ 314.50, 314.60, 314.70 and 314.71.) Section 314.93 sets forth requirements for submitting a suitability petition in accordance with 21 CFR 10.20 and 21 CFR 10.30. (The burden hours for § 314.93 are already approved by OMB under 0910-0183 and are not included in the burden estimates in table 1 of this document.) Section 314.94(a) and

(d)requires that an ANDA contain the following information: Application form; table of contents; basis for ANDA submission; conditions of use; active ingredients; route of administration, dosage form, and strength; bioequivalence; labeling; chemistry, manufacturing, and controls; samples; and patent certification. Section 314.95 requires that any notice of certification of invalidity or noninfringement of a patent to each patent owner and the NDA holder be sent by ANDA applicants. Section 314.96 sets forth requirements for amendments to an unapproved ANDA. Section 314.97 sets forth requirements for submitting supplements to an approved ANDA for changes that require FDA approval. Section 314.98(a) sets forth postmarketing adverse drug experience reporting and recordkeeping requirements for ANDAs. (The burden hours for § 314.98(a) are already approved by OMB under OMB control numbers 0910-0230 and 0910-0291 and are not included in the burden estimates in table 1 of this document.) Section 314.98(c) requires other postmarketing reports for ANDAs: Field alert reports (Form FDA 3331), annual reports (Form FDA 2252), and advertisements and promotional labeling (Form FDA 2253). (The information collection burden estimate for field alert reports is included in table 1 of this document under § 314.81(b)(1); the estimate for annual reports is included under § 314.81(b)(2); the estimate for advertisements and promotional labeling is included under § 314.81(b)(3)(i).) Section 314.99(a) requires that sponsors comply with certain reporting requirements for withdrawing an unapproved ANDA and for a change in ownership of an ANDA. Section 314.99(b) sets forth requirements for sponsors who request waivers from FDA for compliance with §§ 314.92 through 314.99. (The information collection burden estimate for ANDA waiver requests is included in table 1 of this document under estimates for § 314.94(a) and

(d)and §§ 314.96 and 314.97.) Section 314.101(a) states that if FDA refuses to file an application, the applicant may request an informal conference with FDA and request that the application be filed over protest. Section 314.107(c) requires notice to FDA by the first applicant to submit a substantially complete ANDA containing a certification that a relevant patent is invalid, unenforceable, or will not be infringed of the date of first commercial marketing. Section 314.107(e) requires that an applicant submit a copy of the entry of the order or judgment to FDA within 10 working days of a final judgment. Section 314.107(f) requires that ANDA or section 505(b)(2) applicants notify FDA immediately of the filing of any legal action filed within 45 days of receipt of the notice of certification. A patent owner may also notify FDA of the filing of any legal action for patent infringement. If the patent owner or approved application holder who is an exclusive patent licensee waives its opportunity to file a legal action for patent infringement within the 45-day period, the patent owner or approved application holder must submit to FDA a waiver in the specified format. Section 314.110(a)(3) and (a)(4) states that, after receipt of an FDA approvable letter, an applicant may request an opportunity for a hearing on the question of whether there are grounds for denying approval of the application. (The burden hours for § 314.110(a)(3) and (a)(4) are included under parts 10 through 16 (21 CFR parts 10 through 16) hearing regulations, in accordance with § 314.201, and are not included in the burden estimates in table 1 of this document.) Section 314.110(a)(5) states that, after receipt of an approvable letter, an applicant may notify FDA that it agrees to an extension of the review period so that it can determine whether to respond further. Section 314.110(b) states that, after receipt of an approvable letter, an ANDA applicant may request an opportunity for a hearing on the question of whether there are grounds for denying approval of the application. (The burden hours for § 314.110(b) are included under parts 10 through 16 hearing regulations, in accordance with § 314.201, and are not included in the burden estimates in table 1 of this document.) Section 314.120(a)(3) states that, after receipt of a not approvable letter, an applicant may request an opportunity for a hearing on the question of whether there are grounds for denying approval of the application. (The burden hours for § 314.120(a)(3) are included under parts 10 through 16 hearing regulations, in accordance with § 314.201, and are not included in the hour burden estimates in table 1 of this document.) Section 314.120(a)(5) states that, after receipt of a not approvable letter, an applicant may notify FDA that it agrees to an extension of the review period so that it can determine whether to respond further. Section 314.122(a) requires that an ANDA or a suitability petition that relies on a listed drug that has been voluntarily withdrawn from sale must be accompanied by a petition seeking a determination whether the drug was withdrawn for safety or effectiveness reasons. (The burden hours for § 314.122(a) are already approved by OMB under OMB control number 0910-0183 and are not included in the burden estimates in table 1 of this document.) Section 314.122(d) sets forth requirements for relisting petitions for unlisted discontinued products. (The burden hours for § 314.122(d) are already approved by OMB under OMB control number 0910-0183 and are not included in the burden estimates in table 1 of this document.) Section 314.126(c) sets forth requirements for a petition to waive criteria for adequate and well-controlled studies. (The burden hours for § 314.126(c) are already approved by OMB under 0910-0183 and are not included in the burden estimates in table 1 of this document.) Section 314.151(a) and

(b)set forth requirements for the withdrawal of approval of an ANDA and the applicant's opportunity for a hearing and submission of comments. (The burden hours for § 314.151(a) and

(b)are included under parts 10 through 16 hearing regulations, in accordance with § 314.201, and are not included in the burden estimates in table 1 of this document.) Section 314.151(c) sets forth the requirements for withdrawal of approval of an ANDA and the applicant's opportunity to submit written objections and participate in a limited oral hearing. (The burden hours for § 314.151(c) are included under parts 10 through 16 hearing regulations, in accordance with § 314.201, and are not included in the burden estimates in table 1 of this document.) Section 314.152(b) sets forth the requirements for suspension of an ANDA when the listed drug is voluntarily withdrawn for safety and effectiveness reasons, and the applicant's opportunity to present comments and participate in a limited oral hearing. (The burden hours for § 314.152(b) are included under parts 10 through 16 hearing regulations, in accordance with § 314.201, and is not included in the burden estimates in table 1 of this document.) Section 314.161(b) and

(e)sets forth the requirements for submitting a petition to determine whether a listed drug was voluntarily withdrawn from sale for safety or effectiveness reasons. (The burden hours for § 314.161(b) and

(e)are already approved by OMB under OMB control number 0910-0183 and are not included in the burden estimates in table 1 of this document.) Section 314.200(c), (d), and

(e)requires that applicants or others subject to a notice of opportunity for a hearing who wish to participate in a hearing file a written notice of participation and request for a hearing as well as the studies, data, and so forth, relied on. Other interested persons may also submit comments on the notice. This section also sets forth the content and format requirements for the applicants' submission in response to notice of opportunity for hearing. (The burden hours for §§ 314.200(c), (d), and

(e)are included under parts 10 through 16 hearing regulations, in accordance with § 314.201, and are not included in the burden estimates in table 1 of this document.) Section 314.200(f) states that participants in a hearing may make a motion to the presiding officer for the inclusion of certain issues in the hearing. (The burden hours for § 314.200(f) are included under parts 10 through 16 hearing regulations, in accordance with § 314.201, and are not included in the burden estimates in table 1 of this document.) Section 314.200(g) states that a person who responds to a proposed order from FDA denying a request for a hearing provide sufficient data, information, and analysis to demonstrate that there is a genuine and substantial issue of fact which justifies a hearing. (The burden hours for § 314.200(g) are included under parts 10 through 16 hearing regulations, in accordance with § 314.201, and is not included in the burden estimates in table 1 of this document.) Section 314.420 states that an applicant may submit to FDA a drug master file in support of an application, in accordance with certain content and format requirements. Section 314.430 states that data and information in an application are disclosable under certain conditions, unless the applicant shows that extraordinary circumstances exist. (The burden hours for § 314.430 is included under parts 10 through 16 hearing regulations, in accordance with § 314.201, and is not included in the burden estimates in table 1 of this document.) Section 314.530(c) and

(e)states that, if FDA withdraws approval of a drug approved under the accelerated approval procedures, the applicant has the opportunity to request a hearing and submit data and information. (The burden hours for § 314.530(c) and

(e)are included under parts 10 through 16 hearing regulations, in accordance with § 314.201, and are not included in the burden estimates in table 1 of this document.) Section 314.530(f) requires that an applicant first submit a petition for stay of action before requesting an order from a court for a stay of action pending review. (The burden hours for § 314.530(f) are already approved by OMB under 0910-0194 and are not included in the burden estimates in table 1 of this document.) Section 314.610(b)(1) requires that applicants include a plan or approach to postmarketing study commitments in applications for approval of new drugs when human efficacy studies are not ethical or feasible, and provide status reports of postmarketing study commitments. (The information collection burden estimate for § 314.610(b)(1) is included in table 1 of this document under the estimates for §§ 314.50(a), (b), (c), (d), (e), (f), and

(k)and 314.81(b)(2)). Section 314.610(b)(3) requires that applicants propose labeling to be provided to patient recipients in applications for approval of new drugs when human efficacy studies are not ethical or feasible. (The information collection burden estimate for § 314.610(b)(3) is included in table 1 of this document under the estimates for § 314.50(e)). Section 314.630 requires that applicants provide postmarketing safety reporting for applications for approval of new drugs when human efficacy studies are not ethical or feasible. (The burden hours for § 314.630 are already approved by OMB under OMB control numbers 0910-0230 and 0910-0291 and are not included in the burden estimates in table 1 of this document.) Section 314.640 requires that applicants provide promotional materials for applications for approval of new drugs when human efficacy studies are not ethical or feasible. (The information collection burden estimate for § 314.640 is included in table 1 of this document under the estimates for § 314.81(b)(3)(i)). Respondents to this collection of information are all persons who submit an application or abbreviated application or an amendment or supplement to FDA under part 314 to obtain approval of a new drug, and any person who owns an approved application or abbreviated application. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section [Form Number] No. of Respondents No. of Responses per Respondent Total Annual Responses Hours per Response Total Hours 314.50(a), (b), (c), (d), (e), (f), and

(k)85 1.41 120 1,917 230,040 314.50(i) and 314.94(a)(12) 96 9.61 923 2 1,846 314.50(j) 71 4.02 286 2 572 314.52 and 314.95 71 3.66 260 16 4,160 314.60 305 15.05 4,590 80 367,200 314.65 13 1.08 14 2 28 314.70 and 314.71 281 9.30 2,613 150 391,950 314.72 69 3.40 235 2 470 314.81(b)(1) [3331] 114 2.68 306 8 2,448 314.81(b)(2) [2252] 724 11.15 8,073 40 322,920 314.81(b)(3)(i) [2253] 390 61.39 23,942 2 47,884 314.94(a)(1) through (a)(11) and

(d)110 7.21 793 480 380,640 314.96 300 28 8,400 80 672,000 314.97 215 20.66 4,442 80 355,360 314.99(a) 40 2.02 81 2 162 314.101(a) 1 1 1 .50 .50 314.107(c) 56 4.1 230 .50 115 314.107(e) 25 3.92 98 .50 49 314.107(f) 56 4.1 230 .50 115 314.110(a)(5) 45 1.15 52 .50 26 314.120(a)(5) 10 1.20 12 .50 6 314.420 487 1.98 964 61 58,804 Total 2,836,795.5 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Please note that in January 2008, the FDA Web site is expected to transition to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. After the transition date, electronic submissions will be accepted by FDA through the FDMS only. When the exact date of the transition to FDMS is known, FDA will publish a **Federal Register** notice announcing that date. Dated: December 27, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-25593 Filed 1-3-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0367] Draft Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval; Availability; Reopening of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of comment period. SUMMARY: The Food and Drug Administration

(FDA)is reopening until February 8, 2008, the comment period for the draft guidance for industry entitled “Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval,” published in the **Federal Register** of October 15, 2007 (72 FR 58312). The draft guidance informed industry of FDA's current thinking regarding appropriate clinical study designs to evaluate antibacterial drugs, and asked sponsors to amend ongoing or completed studies accordingly. FDA is taking this action in response to a request for an extension of the comment period to allow interested persons additional time to review the draft guidance and submit comments. DATES: Submit written or electronic comments by February 8, 2008. 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 either *http://www.fda.gov/dockets/ecomments* or *http://www.regulations.gov* . See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Edward Cox, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave.,Bldg. 22, rm. 6412, Silver Spring, MD 20993-0002, 301-796-1300. SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** of October 15, 2007 (72 FR 58312), FDA published a notice announcing the availability of a draft guidance for industry entitled “Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval.” The purpose of the guidance is to inform industry of FDA's current thinking regarding appropriate clinical study designs to evaluate antibacterial drugs, and to ask sponsors to amend ongoing or completed studies accordingly. The guidance is in response to a number of public discussions in recent years regarding the use of active-controlled studies designed to show noninferiority as a basis for approval of antibacterial drug products. Some of these discussions have focused on specific diseases such as acute bacterial sinusitis, acute bacterial otitis media, and acute bacterial exacerbation of chronic bronchitis. These public discussions have contributed to FDA's evolving understanding of the science of clinical trials and, in particular, the appropriate role of active-controlled studies designed to show noninferiority in the development of antibacterial drug products. The draft guidance recommends that sponsors provide justification for the treatment effect size and the proposed noninferiority margin for all antibacterial development programs for which approval will rely on noninferiority studies. The initial comment period for this guidance closed on December 14, 2007. II. Reopening of Comment Period On November 13, 2007, the Pharmaceutical Research and Manufacturers of America requested an extension beyond the December 14, 2007, deadline for the submission of comments. FDA recognizes the effect this guidance may have on the development of new antimicrobial products and that additional time may be needed for comment. Therefore, FDA has decided to reopen the comment period on the draft guidance until February 8, 2008, to allow the public more time to review and comment on its contents. III. How to Submit 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 to 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. Please note that in January 2008, the FDA Web site is expected to transition to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. After the transition date, electronic submissions will be accepted by FDA through the FDMS only. When the exact date of the transition to FDMS is known, FDA will publish a **Federal Register** notice announcing that date. 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: December 27, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-25601 Filed 1-3-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0489] Request for Comments on the Science and Technology Report; Establishment of Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; establishment of docket; request for comments. SUMMARY: On March 31, 2006, the Food and Drug Administration

(FDA)charged the Science Board to evaluate FDA's science-based capacities to meet current and future public health challenges. The Science Board established a subcommittee on science and technology to perform the review and draft a report of findings and preliminary recommendations. The subcommittee report was presented and discussed at the December 3, 2007, Science Board Advisory Committee meeting, at which time the Science Board decided to obtain comments from the public on the subcommittee report. FDA is soliciting public comment on the subcommittee report on behalf of the Science Board. DATES: To be considered, written or electronic comments on the subcommittee report must be received on or before February 4, 2008. All comments received while the docket is open will be forwarded to the Science Board for their review. ADDRESSES: Electronic comments should be submitted to *http://www.fda.gov/dockets/ecomments* . Select Docket No. 2007N-0489, “FDA Report on Science and Technology” and follow prompts to submit your statement. Written comments should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, by close of business on (see **DATES** ). All comments should 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. All comments received will be posted without change, including any personal information provided. All comments received while the docket is open will be forwarded to the Science Board for their review. All comments will also be discussed at the next Science Board Advisory Committee meeting. A notice of the next Science Board Advisory Committee meeting will be published at a later date. See **SUPPLEMENTARY INFORMATION** section for elctronic access. FOR FURTHER INFORMATION CONTACT: Carlos Peña, Office of the Commissioner, Food and Drug Administration (HF-33), 5600 Fishers Lane, Rockville, MD 20857, 301-827-6687, FAX: 301-827-3340, e-mail: *carlos.Peña,@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background On March 31, 2006, FDA charged the Science Board to conduct a broad review of FDA scientific capacities, processes, and infrastructure which support FDA's core regulatory functions including the following:

(1)Premarket review and consultation during the development of new FDA-regulated products;

(2)oversight of marketed product quality; and

(3)postmarket product safety surveillance and risk management. The following is the Commissioner of Food and Drugs' charge to the Science Board: “Review and report the broad categories of scientific and technologic capacities that FDA needs to fully support its core regulatory functions and decisionmaking throughout the product life-cycle, today and over the next decade.” Specifically:

(1)Are there any important gaps in current scientific capacities in which FDA should substantially increase efforts, to ensure that it can address current or expected scientific demands of FDA's regulatory mission? In what areas should the agency maintain or strengthen its current level of work and capacity?

(2)Are there areas of science in which the agency should consider refocusing its efforts in order to better address current or anticipated future scientific demands of FDA's regulatory mission?

(3)What opportunities exist to enhance the overall effectiveness of FDA's scientific and technologic capacity through coordination of scientific activities and priority setting across FDA components?

(4)What opportunities exist to better leverage FDA's scientific capacity through collaboration with other public agencies and private organizations? Are there other approaches to resource leveraging that FDA could pursue to better support needed scientific capacities? The review was initiated to obtain advice regarding current science-based capacities and the degree to which they can prepare FDA for anticipated changes in science, technology and population health needs. To respond to this request from the agency, the Science Board established a subcommittee on science and technology to perform the review. The subcommittee was supported by 30 outside experts, who were drawn from government, academia, and industry. Their efforts culminated in a subcommittee report of findings and preliminary recommendations. The subcommittee report was presented and discussed at the December 3, 2007, Science Board Advisory Committee meeting, at which time the Science Board decided to obtain comments from the public on the subcommittee report (an electronic copy of the subcommittee report is available at *http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.html* ). II. Request for Comments In accordance with 21 CFR 14.35, FDA is soliciting public comment on the subcommittee report, on behalf of the Science Board. Comments received while the docket is open will be forwarded to the Science Board for their review. Comments will also be discussed at the next Science Board Advisory Committee meeting. A notice of the next Science Board Advisory Committee meeting will be published in the **Federal Register** at a later date. III. Submission of Comments To help facilitate the public comment process upon the subcommittee report, FDA has established a public docket, on behalf of the Science Board. All comments submitted to the public docket are public information and may be posted to the FDA's Web site at: *http://www.fda.gov* for public viewing. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments received may be reviewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that in January 2008, the FDA Web site is expected to transition to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. After the transition date, electronic submissions will be accepted by FDA through the FDMS only. When the exact date of the transition to FDMS is known, FDA will publish a **Federal Register** notice announcing that date. Dated: December 28, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7-25607 Filed 1-3-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Comment Request In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Public Law 104-13), the Health Resources and Services Administration

(HRSA)publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer on

(301)443-1129. Comments are invited on:

(a)The proposed collection of information for the proper performance of the functions of the agency;

(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;

(c)ways to enhance the quality, utility, and clarity of the information to be collected; and

(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: Sickle Cell Disease Treatment Demonstration Program (SCDTDP), Health Resources and Services Administration (HRSA): NEW In 2004 Congress enacted and the President signed into law Pub. L. 108- 357, the American Jobs Creation Act of 2004. Section 712 of Pub. L. 108-357 authorized a demonstration program for the prevention and treatment of Sickle Cell Disease. The legislation was enacted to

(1)create an optional medical assistance program for individuals with Sickle Cell Diseases for treatment and education, genetic counseling and other services to prevent mortality and decrease morbidity from Sickle Cell Disease, and

(2)create a demonstration program, the SCDTDP, under HRSA. The SCDTDP provides grants to federally-qualified and nonprofit health care providers to establish geographically distributed regional networks that will work with comprehensive Sickle Cell Disease centers and community-based support organizations to provide coordinated, comprehensive, culturally competent, and family-centered care to families with Sickle Cell Disease. In fiscal year 2006, HRSA awarded four, 4-year grants to the Illinois Sickle Cell Association Network, Alabama Network for Sickle Cell Care, Access, Prevention, and Education, Carolina Partnership for Sickle Cell Treatment Continuum of Care, and the Cincinnati Sickle Cell Network. Under the authorizing legislation, a National Coordinating Center

(NCC)was established to

(1)collect, coordinate, monitor, and distribute data, best practices and findings regarding the activities of the demonstration program;

(2)identify a model protocol for eligible entities with respect to the prevention and treatment of Sickle Cell Disease;

(3)identify educational materials regarding the prevention and treatment of Sickle Cell Disease; and

(4)prepare a final report on the efficacy of the demonstration program based on evaluation findings. As part of the evaluation, pre- and post-utilization and satisfaction data and quality of life assessments will be collected from the demonstration clients during various phases of their participation. These data will be collected through medical record abstractions and self-report using hard copy questionnaires and submitted to the NCC for processing and analysis. The total burden estimate per participant is shown below: Type of respondent Form name Number of respondents Responses per respondent Hours per response Total burden hours Sickle Cell Disease clients or caregivers Utilization Questionnaire (pre-demonstration) 400 1 .75 300 hours. Sickle Cell Disease clients or caregivers Utilization Questionnaire (post-demonstration) 400 1 .50 hours 200 hours. Sickle Cell Disease clients or caregivers SF-36 Health Survey for adults over 18 years of age; PedsQL for children/adolescents 18 years or younger (Quality of Life) 400 2 .25 hours 200 hours. Sickle Cell Disease clients or caregivers The Medical Home Family Index (Health Care Satisfaction) 400 2 .25 hours 200 hours. The total burden is 900 hours or 2.25 hours per participant. This would be the maximum level of burden since some of the demonstration networks will be able to abstract medical records for some of the data collected on the Utilization Questionnaire. Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 days of this notice. Dated: December 27, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7-25603 Filed 1-3-08; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration

(HRSA)publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on

(301)443-1129. The following request has been submitted to OMB for review under the Paperwork Reduction Act of 1995: Proposed Project: Application for the National Health Service Corps

(NHSC)Scholarship Program (OMB No. 0915-0146): Reinstatement With Change The National Health Service Corps

(NHSC)Scholarship Program's mission is to ensure the geographic distribution of physicians and other health practitioners in the United States. Under this program, health professions students are offered scholarships in return for service in a federally designated Health Professional Shortage Area (HPSA). The Scholarship Program provides the NHSC with the health professionals it requires to carry out its mission of providing primary health care to HPSA populations in areas of greatest need. Students are supported who are well qualified to participate in the NHSC Scholarship Program and who want to assist the NHSC in its mission, both during and after their period of obligated service. The application form is being revised to streamline the application process and collect the most relevant information necessary to make determinations of award. Scholars are selected for these competitive awards based on the information provided in the application and supporting documentation. Awards are made to applicants who demonstrate a high potential for providing quality primary health care services. The estimated response burden is as follows: Form Number of respondents Responses per respondent Total responses Hours per response Total burden hours Application 1800 1 1800 3 5,400 Total 1800 1800 5,400 Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to the desk officer for HRSA, either by e-mail to *OIRA_submission@omb.eop.gov* or by fax to 202-395-6974. Please direct all correspondence to the “attention of the desk officer for HRSA.” Dated: December 27, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7-25604 Filed 1-3-08; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Committee on Infant Mortality; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting: *Name:* Advisory Committee on Infant Mortality (ACIM). *Dates and Times:* January 23, 2008, 9 a.m.-5 p.m. January 24, 2008, 8:30 a.m.-3 p.m. *Place:* Westin Washington, DC City Center, 1400 M Street, NW., Washington, DC 20005.

(202)429-1700. *Status:* The meeting is open to the public with attendance limited to space availability. *Purpose:* The Committee provides advice and recommendations to the Secretary of Health and Human Services on the following: Department of Health and Human Services' programs that focus on reducing infant mortality and improving the health status of pregnant women and infants; and factors affecting the continuum of care with respect to maternal and child health care. It includes outcomes following childbirth; strategies to coordinate the variety of Federal, State, local and private programs and efforts that are designed to deal with the health and social problems impacting on infant mortality; and the implementation of the Healthy Start Program and *Healthy People 2010* infant mortality objectives. *Agenda:* Topics that will be discussed include the following: HRSA Update, MCHB Update, Healthy Start National Evaluation Update, presentations from a rural Healthy Start project and an urban Healthy Start project, related causes of infant mortality including accidents in the post-neonatal period, and pre-conceptional care. Proposed agenda items are subject to change as priorities indicate. Time will be provided for public comments limited to five minutes each; comments are to be submitted no later than January 2, 2008. FOR FURTHER INFORMATION CONTACT: Anyone requiring information regarding the Committee should contact Peter C. van Dyck, M.D., M.P.H., Executive Secretary, ACIM, Health Resources and Services Administration (HRSA), Room 18-05, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857, Telephone:

(301)443-2170. Individuals who are submitting public comments or who have questions regarding the meeting and location should contact David S. de la Cruz, Ph.D., M.P.H., HRSA, Maternal and Child Health Bureau, telephone:

(301)443-6332, e-mail: *David.delaCruz@hrsa.hhs.gov* . Dated: December 27, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7-25602 Filed 1-3-08; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice of Meeting: Secretary's Advisory Committee on Genetics, Health, and Society Pursuant to Public Law 92-463, notice is hereby given of the fifteenth meeting of the Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS), U.S. Public Health Service. The meeting will be held from 8:30 a.m. to approximately 5:30 p.m. on Tuesday, February 12, 2008 and 8 a.m. to approximately 5 p.m. on Wednesday, February 13, 2008, at the Hubert H. Humphrey Building—200 Independence Avenue SW., Washington, DC 20201. The meeting will be open to the public with attendance limited to space available. The meeting also will be Web cast. The main agenda item will involve deliberations on the oversight of genetic testing, including an overview of public comments received on the Committee's draft report *U.S. System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of HHS* and the formulation of final recommendations to the Secretary. As always, the Committee welcomes hearing from anyone wishing to provide public comment on any issue related to genetics, health and society. Individuals who would like to provide public comment should notify the SACGHS Executive Secretary, Ms. Sarah Carr, by telephone at 301-496-9838 or e-mail at *carrs@od.nih.gov.* The SACGHS office is located at 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892. Anyone planning to attend the meeting who is in need of special assistance, such as sign language interpretation or other reasonable accommodations, is also asked to contact the Executive Secretary. Under authority of 42 U.S.C. 217a, section 222 of the Public Health Service Act, as amended, the Department of Health and Human Services established SACGHS to serve as a public forum for deliberations on the broad range of human health and societal issues raised by the development and use of genetic and genomic technologies and, as warranted, to provided advice on these issues. The draft meeting agenda and other information about SACGHS, including information about access to the Web cast, will be available at the following Web site: *http://www4.od.nih.gov/oba/sacghs.htm.* Dated: December 21, 2007. Jennifer Spaeth, Director, NIH Office of Federal Advisory Committee Policy. [FR Doc. 07-6275 Filed 1-3-08; 8:45 am]