Notices. Notice
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/register/2007/10/22/07-5206·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4184-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0133] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to-Consumer Print Advertisements for Prescription Drugs AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing that a collection of information entitled “Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to-Consumer
(DTC)Print Advertisements for Prescription Drugs” has been approved by the Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995. 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: In the **Federal Register** of March 14, 2007 (72 FR 11889), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0611. The approval expires on October 31, 2010. A copy of the supporting statement for this information collection is available on the Internet at *http://www.fda.gov/ohrms/dockets* . Dated: October 12, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-20756 Filed 10-19-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0114] Electronic Distribution of Prescribing Information for Prescription Drug Products; 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 to December 6, 2007 the comment period for the notice that published in the **Federal Register** of April 2, 2007 (72 FR 15701); this notice was related to the public hearing of April 27, 2007, concerning the electronic distribution of FDA-approved prescribing information currently contained in the package insert
(PI)for prescription drug and biological products. FDA is reopening the comment period for the sole purpose of inviting interested persons to submit comments on the concept of electronic distribution of FDA-approved prescribing information currently contained in the PI for prescription animal drug products. DATES: Submit written or electronic comments by December 6, 2007. ADDRESSES: Submit written comments 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* . FOR FURTHER INFORMATION CONTACT: Erik Mettler, Office of Policy (HF-11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3360, *Erik.Mettler@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** notice of April 2, 2007 (72 FR 15701), FDA published a notice of public hearing concerning the concept of the electronic distribution of PIs for human prescription drugs and biological products and solicited relevant information and comments on this concept. The purpose was to garner views and information on the feasibility of establishing an efficient process for industry to electronically distribute prescribing information to dispensers. The PIs with prescribing information accompany prescription human drugs to meet the requirement that “labeling on or within the package from which the drug is to be dispensed bears adequate information for its use * * *” (21 CFR 201.100(c)(1)). For additional information, see the April 2, 2007, notice ( 72 FR 15701). Currently, the PI contains the prescribing information for the safe and effective use of the product in the form of a paper leaflet. Although the information in the PI is a valuable resource, it is often not readily accessible when a healthcare provider who has not physically received the drug makes a treatment decision or discusses treatments with a patient. Additionally, the PI may not contain the most current information, because the PI accompanying the drug's distribution may have been printed and distributed prior to more recent labeling changes. Accordingly, with technological advances in the electronic transmission of information, we are considering how prescribing information could be more effectively disseminated. FDA is reopening the comment period for the sole purpose of inviting interested persons to submit comments addressing a number of questions regarding the current use of package inserts for animal drug products and those logistical issues associated with electronic distribution of such prescribing information for animal drug products. The previous request for comments was limited to human drugs and biologics. As with prescription human drugs, the PIs with prescribing information accompany prescription animal drugs to meet the requirement that “labeling on or within the package from which the drug is to be dispensed bears adequate information for its use * * *” (21 CFR 201.105(c)(1)). FDA approves the prescribing information as part of both human and animal drug labeling in the drug application. The request for comment is to gain a better understanding of how PIs for animal drugs are currently used by healthcare entities as we consider new approaches for the dissemination of labeling information. II. Issues for Discussion FDA is specifically interested in receiving comments on the following questions and any other pertinent information related to the electronic distribution of the prescribing information for animals. A. General
(1)Currently, who uses and benefits from the prescribing information?
(2)How can electronic distribution and access of the prescribing information be accomplished?
(3)Would electronic distribution and access of the prescribing information improve the public health?
(4)Would electronic distribution and access of prescribing information improve prescribing habits? If so, how?
(5)How might we ensure that changes in the distribution and access of the prescribing information will not negatively affect the current users?
(6)Would an increase in electronic access to prescribing information affect prescribers, pharmacists, clients and patients? If so, how?
(7)Are there any issues particular to the prescribing information for animal drugs that are dissimilar or distinct from those associated with human drugs and that might affect the feasibility of electronic distribution of labeling? B. Logistics
(1)Generally and without focusing on vendor-specific methods, how can electronic distribution of prescribing information be accomplished?
(2)What are the costs associated with the successful implementation of electronic distribution and access to prescribing information, including startup and maintenance expenses? Please breakdown costs per healthcare sector.
(3)Is the technology and infrastructure currently available to accomplish electronic distribution and access? If so, what is available? If not, what is needed?
(4)What are other potential barriers to accomplishing the electronic prescribing information?
(5)How can we ensure that electronic prescribing information is accessible to those who need the information?
(6)How do we meet the needs of those who do not have electronic capability?
(7)In case of emergency or when a computer system is down, what might be the backup?
(8)How should electronically disseminated prescribing information be regularly updated and remain current?
(9)What are the roles for the involved parties (manufacturers, third-parties, health professionals, FDA, and consumers)?
(10)Should all products have electronic prescribing information or are there some products or classes of products that should continue to have paper prescribing information accompany the product?
(11)If electronic prescribing information were to be used instead of paper inserts, then how should electronic prescribing information be implemented? Should electronic prescribing information be phased in? If so, over what time period? Which products should use electronic prescribing information first? 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 *http://www.fda.gov/dockets/ecomments* 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 at the heading of this document. Received comments may be seen in the office above between 9 a.m. and 4 p .m., Monday through Friday. Dated: October 16, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-20759 Filed 10-19-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration HRSA's Bureau of Primary Health Care
(BPHC)Awards Unsolicited Proposal for Cooperative Agreement to the National Network for Oral Health Access AGENCY: Health Resources and Services Administration (HRSA), HHS. ACTION: HRSA's Bureau of Primary Health Care
(BPHC)announces the award of an unsolicited proposal from the National Network for Oral Health Access (NNOHA) to establish a cooperative agreement with HRSA providing services and resources to support the Health Center Program's oral health providers serving the oral health needs of underserved populations. *Recipient:* National Network for Oral Health Access, Ft. Lupton, Colorado. *Purpose of the award:* Cooperative Agreement with HRSA to provide services and resources to support the Health Center Program's oral health providers serving the oral health needs of underserved populations. *Amount of award:* $200,000. *Project period:* 1 year; September 25, 2007, to September 24, 2008. SUMMARY: HRSA's BPHC has performed a formal review of an unsolicited proposal from NNOHA to establish a cooperative agreement with HRSA to provide services and resources to support the Health Center Program's oral health providers serving the oral health needs of underserved populations. BPHC has reviewed the proposal and has determined that it has merit. This request is of strategic importance to the Department of Health and Human Services
(HHS)and is time critical. Funding for the proposed activities will promote access to oral health services as an integral component of primary health care, improve the quality of those services provided, and sustain the forward motion of departmental priorities in this area. The Cooperative Agreement with NNOHA will have a project period of 1 year with funding at $200,000. The funds will support selected activities described in the application to develop a national infrastructure to support improved access to oral health care, and improved quality and workforce development for the growing number of health center oral health programs. The key anticipated outcomes of the proposed cooperative agreement are as follows: • The development of oral health clinical quality infrastructure to support HRSA in achieving its goal of improved quality of care; • The development of a recruitment and retention strategy to address dentist and dental hygienist vacancies, including National Health Service Corps dentist and dental hygiene openings; and • NNOHA will work in collaboration with HRSA to implement a strategy to integrate oral health as it moves all of its programs forward in Health Information Technology to assure that oral health strategies are included. There is a strategic importance of access to oral health as part of the primary care services supported by BPHC's Health Center Program. The Health Center Program has had significant growth as part of the President's Health Center Initiative. The number of patients seen by the Health Center Program has increased by 90 percent. Health centers have reported significant challenges recruiting and retaining oral health providers. Consequently, HRSA has determined that the scope of this proposal is immediate and necessary. The proposed outcomes will contribute to the success and quality of oral health programs and are essential for long term sustainability and viability of health centers funded by HRSA. This award is being made non-competitively because there is no current, pending, or planned funding opportunity announcement under which this proposal could be competed. HRSA/BPHC has identified three key reasons to support rationale for not awarding competitively: 1. NNOHA is uniquely positioned to provide oral health program support services on a national basis to community health centers. As the only organization of health center dental providers, NNOHA is dedicated to increasing the effectiveness of dental programs in reaching all underserved populations by supporting efforts to strengthen existing health center dental programs; manage the growth of new health center dental programs; and manage the quality improvement in health center dental programs. 2. With this experience, and its nationwide membership of health center dentists, NNOHA has a proven track record of effective collaborations with health center dental programs. Increased access to quality oral health is enhanced through NNOHA's partnerships with organizations and governmental agencies at the local, State and national levels. 3. No other organization has the national scope of respected experience in the area of health center oral health leadership and can perform immediately, especially given the complexity of activities that are critical to HRSA. Legislative Authority: Section 330(l) of the Public Health Service Act. FOR FURTHER INFORMATION CONTACT: Jay R. Anderson, DMD, MHSA, Office of Quality and Data, Bureau of Primary Health Care, Health Resources and Services Administration. Dr. Anderson may be contacted by e-mail at *Janderson@hrsa.gov* or via telephone at
(301)594-4295. Dated: October 15, 2007. Elizabeth M. Duke, Administrator. [FR Doc. E7-20703 Filed 10-19-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* National Heart, Lung, and Blood Institute Special Emphasis Panel Research Scientist Development and Clinical Investigator Awards (K02's & K08's). *Date:* November 1-2, 2007. *Time:* 8 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Marriott Baltimore/Washington Int'l Airport, 1743 West Nursery Road, Baltimore, MD 21240. *Contact Person:* David A Wilson, PhD, Scientific Review Administrator, Review Branch/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7204, Bethesda, MD 20892-7924,
(301)435-0299, *wilsonda2@nhlbi.nih.gov.* This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. *Name of Committee:* National Heart, Lung, and Blood Institute Special Emphasis Panel Research Demonstration and Dissemination Projects. *Date:* November 14, 2007. *Time:* 1 p.m. to 3 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Telephone Conference Call). *Contact Person:* Holly Patton, PhD, Scientific Review Administrator, Review Branch/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7188, Bethesda, MD 20892-7924, 301-435-0280, *pattonh@nhlbi.nih.gov.* (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS). Dated: October 15, 2007. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 07-5206 Filed 10-19-07; 8:45 am]
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