Fed. Reg. Notices — Notice

BILLING CODE 4150-24-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30 Day-07-05CO] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention

(CDC)publishes a list of information collection requests under review by the Office of Management and Budget

(OMB)in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at

(404)639-5960 or send an e-mail to *omb@cdc.gov.* Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to

(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project The Centers for Disease Control and Prevention's Consumer Response Services Center (CDC-INFO) Evaluation-New-National Center for Health Marketing (NCHM), Centers for Disease Control and Prevention (CDC). Background and Brief Description CDC is launching an integrated “one face to the public” approach across all communication channels to handle inquiries concerning a broad spectrum of public health topics. The overall objective is to ensure consistent, timely, reliable health information for dissemination to a variety of consumers (public, health professionals, researchers, etc.) and to address variations in inquiry volumes related to public health emergencies, news events, and dynamic, shifting public health priorities. The CDC has integrated over 40 hotlines into one Consumer Response Services Center CDC-INFO. CDC-INFO has an exceptionally wide scope because content currently divided between over 40 hotlines handling nearly 2,000,000 telephone contacts annually will be consolidated under CDC-INFO. All CDC hotlines were consolidated in one center beginning in February 2005, with all CDC program areas transitioning into CDC-INFO through a phased approach during the next three years. CDC-INFO itself will be operational for at least the next seven years. The primary objectives of the national evaluation are to

(1)Proactively evaluate customer interactions and service effectiveness by employing assessment measures and data collection mechanisms to support performance management, gathering insights and understandings for improving service levels, and implementing effective measures to meet customer satisfaction goals;

(2)develop an ongoing understanding of customer requirements and satisfaction trends to achieve best of practice quality standards and to provide qualitative assessments, quantitative data, and cost factors to drive improvement and reinforce operational objectives;

(3)measure CDC-INFO contractor service performance to assist in determining whether performance incentives have been achieved; and

(4)to collect data in order to address public concern and response to emergencies, outbreaks, and media events. Sample size, respondent burden, and intrusiveness have been minimized to be consistent with national evaluation objectives. Procedures will be employed to safeguard the privacy and confidentiality of participants. Pilot tests assisted in controlling burden and ensuring the user-relevance of questions. The following table shows the estimated annualized burden for data collection. There are no respondent costs other than the amount of time required to respond to the survey. Estimated Annualized Burden Hours Data collection instrument Number of respondents Responses/ respondent Average burden per response (in hrs) Average annual burden hours Satisfaction survey (callers) 25,000 1 3/60 1,250 Satisfaction survey (e-mail inquiries) 330 1 3/60 17 Follow up survey 3,125 1 7/60 365 Key informant survey 100 1 7/60 12 Postcard survey for bulk mailing 950 1 1/60 16 Postcard survey for individual publications 2,100 1 1/60 35 Web survey for e-mail publication orders 1,000 1 1/60 17 Web survey for internet publications 950 1 1/60 16 Special event/Outreach survey—General Public 25,600 1 5/60 2,133 Special event/Outreach survey—Professionals 10,400 1 5/60 867 Emergency response survey—Level 1 emergency—General Public 31,151 1 5/60 2596 Emergency response survey—Level 1 emergency—Professionals 7,459 1 5/60 622 Emergency response survey—Level 2 emergency—General Public 57,579 1 5/60 4798 Emergency response survey—Level 2 emergency—Professionals 51,821 1 5/60 4318 Emergency response survey—Level 3 emergency—General Public 351,863 1 5/60 29,322 Emergency response survey—Level 3 emergency—Professional 316,678 1 5/60 26,390 Emergency response survey—Level 4 emergency—General Public 645,630 1 5/60 53,803 Emergency response survey—Level 4 emergency—Professional 596,504 1 5/60 49,709 Total Burden Hours 176,286 Dated: February 6, 2007. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-2637 Filed 2-14-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0430] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 356h and 2567; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is correcting a notice that appeared in the **Federal Register** of February 2, 2007 (72 FR 5057). The document announced that an opportunity for public comment on a proposed collection of information had been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. The notice published with an error in titles referring to an FDA form number in two places in the document. This document corrects those errors. DATES: February 15, 2007. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In the **Federal Register** of Friday, February 2, 2007, the following corrections are made on page 5057: 1. In the first column, in the ninth line of the title of the document, the phrase “Forms FDA 456h” is corrected to read “Forms FDA 356h”. 2. In the second column, in the SUPPLEMENTARY INFORMATION section of the document, in the sixth line of the title, the phrase “Forms FDA 456h” is corrected to read “Forms FDA 356h”. Dated: February 8, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-2576 Filed 2-14-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0436] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on How To Use E-Mail To Submit a Study Protocol AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget

(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by March 19, 2007. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance: Guidance for Industry on “How To Use E-Mail To Submit a Study Protocol”—21 CFR 58.120; 21 CFR 514.117(b); (OMB Control Number 0910-0524)—Extension Protocols for nonclinical laboratory studies (safety studies), are required under 21 CFR 58.120 for approval of new animal drugs. Protocols for adequate and well-controlled effectiveness studies are required under 21 CFR 514.117(b). Upon request by the animal drug sponsors, the Center for Veterinary Medicine (CVM), reviews protocols for safety and effectiveness studies that CVM and the sponsor consider to be an essential part of the basis for making the decision to approve or not approve an animal drug application or supplemental animal drug application. Establishing a process for acceptance of the electronic submission of protocols for studies conducted by sponsors in support of new animal drug applications (NADAs), is part of CVM's ongoing initiative to provide a method for paperless submissions. Sponsors may submit protocols to CVM in paper format. CVM's guidance on how to submit a study protocol permits sponsors to submit a protocol without data as an e-mail attachment via the Internet. CVM's guidance on how to submit a study protocol electronically implements provisions of the Government Paperwork Elimination Act (GPEA). The GPEA required Federal agencies, by October 21, 2003, to provide for the:

(1)Option of the electronic maintenance, submission, or disclosure of information, if practicable, as a substitution for paper; and

(2)use and acceptance of electronic signatures, where applicable. FDA is also seeking an extension of an existing paperwork clearance for form FDA 3536 to facilitate the use of electronic submission of protocols. This collection of information is for the benefit of animal drug sponsors, giving them the flexibility to submit data for review via the Internet. In the **Federal Register** of November 8, 2006 (71 FR 65534), FDA published a 60-day notice soliciting public comment on the proposed collection of information requirements. In response to that notice, no comments were received. The likely respondents for this collection of information are sponsors of NADAs. FDA estimates the burden for this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section/ Form No. No. of Respondents Annual Frequency per Response Total Annual Responses 2 Hours per Response Total Hours 514.117 ( b) 58.120 / Form 3536 25 4.2 103 0.20 20.6 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Electronic submissions received between July 1, 2005, and June 30, 2006. The number of respondents in table 1 of this document is the number of sponsors registered to make electronic submissions (25). The number of total annual responses is based on a review of the actual number of such submissions made between July 1, 2005, and June 30, 2006. 103 x hours per response (.20) = 20.6 total hours. Dated: February 8, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-2577 Filed 2-14-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0381] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mammography Quality Standards Act Requirements AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget

(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by March 19, 2007. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. The Mammography Quality Standards Act Requirements—21 CFR Part 900 (OMB Control Number 0910-0309)—Extension Mammography Quality Standards Act requires the establishment of a Federal certification and inspection program for mammography facilities; regulations and standards for accreditation and certification bodies for mammography facilities, and standards for mammography equipment, personnel, and practices, including quality assurance. The intent of these regulations is to ensure safe, reliable, and accurate mammography on a nationwide level. Under the regulations, as a first step in becoming certified, mammography facilities must become accredited by an FDA approved accreditation body. This requires undergoing a review of their clinical images and providing the accreditation body with information showing that they meet the equipment, personnel, quality assurance and quality control standards, and have a medical reporting and recordkeeping program, a medical outcomes audit program, and a consumer compliant mechanism. On the basis of this accreditation, facilities are then certified by FDA or an FDA- approved State certification agency and must prominently display their certificate. These actions are taken to ensure safe, accurate, and reliable mammography on a nationwide basis. In the **Federal Register** of September 22, 2006 (71 FR 55488), FDA published a 60-day notice soliciting public comments on the information collection requirements of the proposed collection. In response to that notice, no comments were received. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 21 CFR Section/ FDA Form No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Total Capital Costs Total Operating & Maintenance Costs 900.3(b)(1) 0.33 1 0.33 1 0.33 900.3(b)(3) full 1 0.33 1 0.33 320 106 $10,000 900.3(b)(3) limited 2 5 1 5 30 150 900.3(d)(2) 0.1 1 0.1 30 3 900.3(d)(5) 0.1 1 0.1 30 3 900.3(e) 0.1 1 0.1 1 0.1 900.3(f)(2) 0.1 1 0.1 200 20 $36 900.4(c) facility 3 2,947 1 2,947 1.54 4,538 900.4(c) AB 4 6 1 6 378 2,268 $117,867 900.4(d) facility 3 2,947 1 2,947 0.77 2,269 900.4(d) AB 4 6 1 6 189 1,134 900.4(e) facility 3 8,840 1 8,840 1 8,840 $8,840 900.4(e) AB 4 6 1 6 1,473 8,838 900.4(f) 336 1 336 7 2,352 $77,840 900.4(h) facility 3 8,840 1 8,840 1 8,840 $3,536 900.4(h) AB 4 6 1 6 10 60 900.4(i)(2) 1 1 1 16 16 900.6(c)(1) 0.1 1 0.1 60 6 900.11(b)(3) 5 1 5 0.5 2.5 900.11(c) 270 1 270 5 1,350 900.12(c)(2) 8,840 4,072 36,000,000 0.083 3,000,000 $14,400,000 5 900.12(c)(2) patient refusal 5 89 1 89 0.5 44.5 900.12(h)(4) 5 1 5 1 5 900.12(j)(1) facility 3 25 1 25 200 5,000 $250 900.12(j)(1) AB 4 25 1 25 1,000 25,000 $750 900.12(j)(2) 3 1 3 100 300 $3,604 900.15(c) 5 1 5 2 10 900.15(d)(3)(ii) 1 1 1 2 2 900.18(c) 2 1 2 2 4 900.18(e) 2 1 2 1 2 900.21(b) 1 1 1 320 320 $30,000 $71 900.21(c)(2) 0.3 1 0.33 30 10 900.22(h) 6 200 1,200 0.083 100 900.22(i) 2 1 2 30 60 900.23 6 1 6 20 120 900.24(a) 0.3 1 0.3 200 60 $26 900.24(a)(2) 0.15 1 0.15 100 15 $13 900.24(b) 1.2 1 1.2 30 36 900.24(b)(1) 0.3 1 0.3 200 60 $26 900.24(b)(3) 0.15 1 0.15 100 15 $13 900.25(a) 0.2 1 0.2 16 3.2 FDA Form 3422 700 1 700 0.25 175 TOTAL 3,072,138 $40,000 $14,612,872 1 Refers to entities that are applying for the first time. 2 Refers to accreditation bodies applying to accredit specific Full Field Digital Mammography units. 3 Refers to the facility component of the burden for this requirement. 4 Refers to the accreditation body component of the burden for this requirement. 5 Refers to the situation where a patient specifically does not want to receive the lay summary of her exam. **Table 2. —Estimated Annual Recordkeeping Burden** 21 CFR Section Number of Recordkeepers Annual Frequency of Recordkeeping Total Annual Records Hours per Record Total Hours Total Capital Costs Total Operating & Maintenance Costs 900.4(g) 6 1 6 1 6 900.12(a)(1)(i)(B)(2) 89 1 89 8 712 900.12(a)(4) 8,840 4 35,360 1 35,360 900.12(c)(4) 8,840 1 8,840 1 8,840 $25,000 900.12(e)(13) 8,840 52 459,680 0.083 38,154 900.12(f) 8,840 1 8,840 16 141,440 900.12(h)(2) 8,840 2 17,680 1 17,680 900.22(a) 6 1 6 1 6 900.22(d) 6 1 6 1 6 900.22(e) 6 1 6 1 6 900.22(f) 3 1 3 1 3 900.22(g) 6 1 6 1 6 $60 900.25(b) 6 1 6 1 6 Total 242,225 $25,000 $60 This request for OMB approval now serves to consolidate previously issued information collection, OMB control number 0910-0580 into 0910-0309. The hourly burden as well as the associated operating costs were increased to better represent the actual burden and costs on facilities and accreditation bodies. The following regulations were not included in the above burden tables because they were considered usual and customary practice and were part of the standard of care prior to the implementation of the regulations. Therefore, they resulted in no additional reporting or recordkeeping burden: 21 CFR 900.12(c)(1) and (c)(3) and § 900.3(f)(1) (21 CFR 900.3(f)(1)). The following regulations were not included in the above burden tables because they were not considered applicable during the information collection period or their burdens were reported under other regulatory requirements. Therefore, they resulted in no additional reporting or recordkeeping burden: § 900.3(c), 21 CFR 900.11(b)(1) and (b)(2), and 900.24(c). Dated: February 8, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-2578 Filed 2-14-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0434] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on How to Use E-Mail to Submit a Request for a Meeting or Teleconference to the Office Of New Animal Drug Evaluation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget

(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by March 19, 2007. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. How to Use E-Mail to Submit a Request for a Meeting or Teleconference to the Office Of New Animal Drug Evaluation—21 CFR 10.65 (OMB Control Number 0910-0452)—Extension The Center for Veterinary Medicine

(CVM)holds meetings and /or teleconferences when a sponsor requests a presubmission conference under 21 CFR 514.5, or requests a meeting to discuss general questions. Generally, meeting requests are submitted to CVM on paper. However, CVM now allows registered sponsors to submit information electronically, and to request meetings electronically, if they determine this is more efficient and time saving for them. CVM's guidance “On How to Use E-Mail to Submit a Request for a Meeting or Teleconference to the Office of New Animal Drug Evaluation” provides sponsors with the option to submit a request for a meeting or teleconference as an e-mail attachment via the internet. In the **Federal Register** of November 8, 2006 (71 FR 65535), FDA published a 60-day notice soliciting comments on the proposed collection of information requirements. In response to that notice, no comments were received. The likely respondents are sponsors for new animal drug applications. CVM estimates the burden for this information collection activity as follows: ** Table 1.—Estimated Annual Reporting Burden 1 ** 21 CFR Section/FDA Form # No. of Respondents Annual Frequency per Response Total Annual Responses 2 Hours per Response Total Hours 10.65/FDA Form 3489 25 6.24 156 .08 12.5 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Electronic submissions received between July 1, 2005 and June 30, 2006. The number of respondents in Table 1 of this document are the number of sponsors registered to make electronic submissions (25). The number of total annual responses is based on a review of the actual number of such submissions made between July 1, 2005, and June 30, 2006. (156 x hours per response (.08) = 12.5 total hours.) Dated: February 8, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-2579 Filed 2-14-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0016] Sentinel Network To Promote Medical Product Safety; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of registration period. SUMMARY: The Food and Drug Administration

(FDA)is extending to February 28, 2007, registration for the public meeting that will be held on March 7 and 8, 2007, regarding FDA's exploration and development of an integrated national network to link private sector and public sector postmarket safety efforts, creating a virtual, integrated, electronic “Sentinel Network”. Such a network would integrate existing and planned efforts to collect, analyze, and disseminate medical product safety information to health care practitioners and patients at the point-of-care. It would be established through multiple, broad-based, public-private partnerships. *Dates and Times* : The public meeting will be held on March 7 and 8, 2007, from 8 a.m. to 5 p.m. *Location* : The public meeting will be held at the University System of Maryland Shady Grove Center, 8630 Gudelsky Dr., Rockville, MD 20850. ADDRESSES: Submit written registration to Erik Mettler, Office of Policy (HF-11), Food and Drug Administration, 5600 Fishers Lane, rm. 14-101, Rockville, MD 20852, 301-827-3360, FAX: 301-594-6777. Submit electronic registration to *Erik.Mettler@fda.hhs.gov* . *For Registration to Attend and/or Participate in the Meeting* : Seating at the meeting is limited. People interested in attending should e-mail or submit written registration to Erik Mettler (see ADDRESSES ) by close of business on February 28, 2007. Registration is free and will be on a first-come, first-serve basis. All individuals wishing to speak during the open session of the meeting must indicate their intent, the question to be addressed, and provide an abstract of the presentation by February 28, 2007. We have set aside a portion of the agenda ( *http://www.fda.gov/oc/op/sentinel/* ) for individuals who would like to make presentations at the meeting. If you wish to make an oral presentation during the open session of the meeting, you must state your intention on your registration submission (see ADDRESSES ). To speak, submit your name, title, business affiliation, address, telephone number, fax number, and e-mail address. FDA will do its best to accommodate requests to speak. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and to request time for a joint presentation. FDA may require joint presentations by persons with common interests. FDA will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled to begin. If you require special accommodations due to a disability, please inform Erik Mettler (see ADDRESSES ) when you register. *For Information On the Meeting Contact* : Erik Mettler (see ADDRESSES ). SUPPLEMENTARY INFORMATION: In the **Federal Register** of January 18, 2007 (72 FR 2284), FDA announced a public meeting to explore opportunities to link private sector and public sector postmarket safety efforts to create a virtual, integrated, electronic “Sentinel Network”. Such a network would integrate existing and planned efforts to collect, analyze, and disseminate medical product safety information to health care practitioners and patients at the point-of-care. It would be established through multiple, broad-based, public-private partnerships. We are seeking input on a number of specific questions, included in the original **Federal Register** notice, regarding opportunities for collaboration, the efficient use of information technology, and the collection and analysis of medical product safety information. A tentative agenda for the 2-day meeting has been posted on FDA's Web site and can be viewed at *http://www.fda.gov/oc/op/sentinel/* . We will post a final agenda by March 1, 2007, at the same Web site. During the course of the registration period, FDA became aware that some registrations were not properly recorded. Because of this and because of the strong interest being expressed in this meeting, the agency has decided to reopen and extend the registration period to February 28, 2007. In light of the fact that we have experienced some registration difficulties, individuals who have already registered can contact Erik Mettler (see ADDRESSES ) if they wish to receive confirmation that their registration has been recorded. Interested parties who have not yet registered may, on or before February 28, 2007, submit to Erik Mettler (see ADDRESSES ) an electronic or written registration. Please include your name, title, business affiliation, address, telephone number, fax number, and e-mail address. Please also indicate if you wish to speak during the open public session or if you would like to register to make a presentation. Dated: February 12, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 07-710 Filed 2-12-07; 2:59 pm]

Notices. Notice