Memorandum of Understanding Between the Food and Drug Administration and Drugs.Com, 29561-29567 [2010-12638]

Download as PDF Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Notices take to reduce those barriers while assuring the safety, effectiveness, and quality of medical devices marketed in the United States. The Council seeks input from a wide range of constituencies to include but not be limited to industry, academia, patient/consumer advocacy groups, professional organizations, and other State and Federal bodies under aligned public health missions, to address the issues outlined in this document. During the public workshop, there will be an open dialogue between Federal Government Council members and experts from the private and public sectors regarding the topics described in this document. Workshop participants will not be expected to develop consensus recommendations, but rather to provide their perspectives on priority areas in which medical device innovations can have the highest positive impact on public health. Participants will also be encouraged to comment on devices not being developed or redesigned due to barriers that the Federal Government can and should directly or indirectly remove or minimize. Additional information on the public workshop, including an agenda, will be made available in advance of June 24, 2010, at https://www.fda.gov/ MedicalDevices/NewsEvents/ WorkshopsConferences/default.htm (select the appropriate meeting from the list). wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1 II. Public Participation If you wish to make an oral presentation during the public workshop, you must indicate this at the time of registration. There are two types of opportunities for participation planned for the public workshop. In one, formal presentations will address one of the two topics (see section III of this document) that will be limited to 15 minutes and require submission of the presentation in advance of the meeting. The other will be time-limited, based on the number of requests, as part of the public comment period. When registering, you will be required to identify the title of the topic you wish to address in your presentation and answer all the related questions on the web registration form. FDA will do its best to accommodate requests to present and will focus discussions to the topics described in this document (see section III of this document). Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and to request time for joint presentations. FDA will determine the amount of time allotted to each VerDate Mar<15>2010 15:16 May 25, 2010 Jkt 220001 presenter and the approximate time that each oral presentation is to begin. III. Issues for Discussion IV. Transcripts Please be advised that as soon as a transcript is available, it can be obtained in either hardcopy or on CD–ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (HFI–35), Office of Management Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6–30, Rockville, MD 20857. A transcript of the public workshop will be available on the Internet at https://www.fda.gov/ MedicalDevices/NewsEvents/ WorkshopsConferences/default.htm (select the appropriate meeting from the list). Frm 00055 Fmt 4703 Sfmt 4703 Dated: May 20, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–12588 Filed 5–25–10; 8:45 am] The workshop will focus on three topics: (1) Identification of the most important unmet public health needs; (2) delineation of the barriers to the development, redesign, and patient and healthcare professional access to medical devices that can cure, significantly improve, or prevent these illnesses or injuries; and (3) identification of the actions the Federal Government can take to remove or minimize these barriers. The discussion of these general topics should not be limited by current statutes or regulations and will include, but not be limited to, discussion of the following questions: 1. Identifying areas of public health need: a. Which unmet public health needs could be most effectively addressed by the development of new, or the redesign of existing, medical devices? b. How should the Council set priorities amongst the identified public health needs? Are there specific factors that should be considered? If so, which and why? 2. Addressing barriers to development and/or redesign of medical devices: a. What are the significant barriers facing innovators, academics, and/or industry that limit the availability and clinical use of medical devices that have the potential to improve public health? b. How should any perceived or actual barriers be evaluated to determine whether federal intervention is appropriate? c. How should federal agencies— including those present and others not represented—address those barriers that are out of proportion to what is warranted based on the public health needs? PO 00000 29561 BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Surveillance, Natural History, Quality of Care and Outcomes of Diabetes Mellitus with Onset in Childhood and Adolescence, RFA DP 10–001, Initial Review Correction: This notice was published in the Federal Register on March 22, 2010, volume 75, Number 54, Page 13560. The Place and time should read as follows: Time and Date: 8:30 a.m.–6 p.m., June 15, 2010 (Closed). Place: W Hotel, 3377 Peachtree Road, NE., Atlanta, GA 30326, Telephone: 678–500–3100. Contact Person for More Information: Donald Blackman, Ph.D., Scientific Review Officer, National Center for Chronic Disease Prevention and Health Promotion, Office of the Director, Extramural Research Program Office, 4770 Buford Highway, NE., Mailstop K– 92, Atlanta, GA 30341, Telephone: (770) 488–3023, E-mail: DBY7@cdc.gov. 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 20, 2010. Andre Tyler, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2010–12627 Filed 5–25–10; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0004] [FDA 225–09–0012] Memorandum of Understanding Between the Food and Drug Administration and Drugs.Com AGENCY: Food and Drug Administration, HHS. E:\FR\FM\26MYN1.SGM 26MYN1 29562 ACTION: Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Notices Notice. wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1 SUMMARY: The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and Drugs.Com. The purpose of the MOU is to extend the reach of FDA Consumer Health Information and to provide consumers with better information and timely content concerning public health and safety topics, including alerts of VerDate Mar<15>2010 15:16 May 25, 2010 Jkt 220001 emerging safety issues and product recalls. DATES: The agreement became effective May 26, 2010. FOR FURTHER INFORMATION CONTACT: Jason Brodsky, Consumer Health Information Staff, Office of External Relations, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5378, Silver Spring, MD 20993–0002, 301–796–8234, e-mail: Jason.Brodsky@fda.hhs.gov. PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 In accordance with 21 CFR 20.108(c), which states that all written agreements and MOUs between FDA and others shall be published in the Federal Register, the agency is publishing notice of this MOU. SUPPLEMENTARY INFORMATION: Dated: May 17, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. E:\FR\FM\26MYN1.SGM 26MYN1 VerDate Mar<15>2010 15:16 May 25, 2010 Jkt 220001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4725 E:\FR\FM\26MYN1.SGM 26MYN1 29563 EN26MY10.008</GPH> wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1 Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Notices VerDate Mar<15>2010 Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Notices 15:16 May 25, 2010 Jkt 220001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4725 E:\FR\FM\26MYN1.SGM 26MYN1 EN26MY10.009</GPH> wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1 29564 VerDate Mar<15>2010 15:16 May 25, 2010 Jkt 220001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4725 E:\FR\FM\26MYN1.SGM 26MYN1 29565 EN26MY10.010</GPH> wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1 Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Notices Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Notices [FR Doc. 2010–12638 Filed 5–25–10; 8:45 am] BILLING CODE 4160–01–S VerDate Mar<15>2010 19:31 May 25, 2010 Jkt 220001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\26MYN1.SGM 26MYN1 EN26MY10.011</GPH> wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1 29566 Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Notices DEPARTMENT OF HOMELAND SECURITY Transportation Security Administration Extension of Agency Information Collection Activity Under OMB Review: Aviation Security Customer Satisfaction Performance Measurement Passenger Survey wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1 AGENCY: Transportation Security Administration, DHS. ACTION: 30-day notice. SUMMARY: This notice announces that the Transportation Security Administration (TSA) has forwarded the Information Collection Request (ICR), OMB control number 1652–0013, abstracted below to the Office of Management and Budget (OMB) for review and approval of an extension of the currently approved collection under the Paperwork Reduction Act. The ICR describes the nature of the information collection and its expected burden. TSA published a Federal Register notice, with a 60-day comment period soliciting comments, of the following collection of information on March 11, 2010. 75 FR 11552. The collection involves surveying travelers to measure customer satisfaction of aviation security in an effort to more efficiently manage airport performance. DATES: Send your comments by June 25, 2010. A comment to OMB is most effective if OMB receives it within 30 days of publication. ADDRESSES: Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to Desk Officer, Department of Homeland Security/TSA, and sent via electronic mail to oira_submission@omb.eop.gov or faxed to (202) 395–6974. FOR FURTHER INFORMATION CONTACT: Joanna Johnson, TSA Paperwork Reduction Act (PRA) Officer, Office of Information Technology (OIT), TSA–11, Transportation Security Administration, 601 South 12th Street, Arlington, VA 20598–6011; telephone (571) 227–3651; e-mail TSAPRA@dhs.gov. SUPPLEMENTARY INFORMATION: Comments Invited In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number. The ICR documentation is VerDate Mar<15>2010 17:47 May 25, 2010 Jkt 220001 available at https://www.reginfo.gov. Therefore, in preparation for OMB review and approval of the following information collection, TSA is soliciting comments to— (1) Evaluate whether the proposed information requirement is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency’s estimate of the burden; (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 using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Information Collection Requirement OMB Control Number 1652–0013; Aviation Security Customer Satisfaction Performance Measurement Passenger Survey. TSA, with OMB’s approval, has conducted surveys of passengers and now seeks approval to continue this effort. TSA plans to conduct passenger surveys at airports nationwide. The surveys will be administered using an intercept methodology. The intercept methodology uses TSA personnel who are not in uniform to hand deliver paper business card style forms that contain a url address to an online survey to passengers immediately following the passenger’s experience with the TSA’s checkpoint security functions. Passengers are invited, though not required, to view and complete the survey via an online portal. The intercept methodology randomly selects times and checkpoints to select passengers to complete the survey in an effort to gain survey data representative of all passenger demographics-including passengers who— • Travel on weekdays or weekends; • Those who travel in the morning, mid-day, or evening; • Those who pass through each of the different security screening locations in the airport; • Those who are subject to more intensive screening of their baggage or person; and • Those who experience different volume conditions and wait times as they proceed through the security checkpoints. The survey includes ten to fifteen questions. Each question promotes a quality response so that TSA can identify areas in need of improvement. All questions concern aspects of the PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 29567 passenger’s security screening experience. TSA intends to collect this information in order to continue to assess customer satisfaction in an effort to more efficiently manage airport performance. In its future surveys, the TSA wishes to obtain more detailed, airport-specific data that the TSA can use to enhance customer experiences and airport performances. In order to gain more detailed information regarding customer experiences, the TSA is submitting eighty-one questions to OMB for approval. Twenty-eight of the questions have been previously approved by OMB and fifty-three questions are being submitted to the OMB for first-time approval. Each survey question seeks to gain information regarding one of the following categories: • Confidence in Personnel. • Confidence in Screening Equipment. • Confidence in Security Procedures. • Convenience of Divesting. • Experience at Checkpoint. • Satisfaction with Wait Time. • Separation from Belongings. • Separation from Others in Party. • Stress Level. Once a time and checkpoint is randomly selected, TSA personnel distribute forms to passengers until the TSA obtains the desired sample size. The samples can be selected with one randomly selected time and location or span multiple times and locations. Each airport uses a business card that directs customers to an online portal. All responses are voluntary and there is no burden on passengers who choose not to respond. All airports have the capability to conduct this survey. Based on prior survey data and research, a sample size of 384 needs approximately 1,000 surveys. TSA assumes that there will be 384 respondents from 1,000 surveys distributed. At an inidividual airport, we assume the burden on passengers who choose to respond to be approximately five-minutes per respondent. Therefore, 384 respondents x 1 airport = 384 respondents a year. It takes approximately 5 minutes for each respondent to complete the survey so the total burden at one airport is 384 respondents x 5 minutes = 1,920 minutes or 32 hours per airport. We estimate that 25 airports will conduct the survey each year. Therefore, 384 respondents x 25 airports = 9,600 respondents a year. Since we assume it takes approximately 5 minutes for each E:\FR\FM\26MYN1.SGM 26MYN1

Agencies

[Federal Register Volume 75, Number 101 (Wednesday, May 26, 2010)]
[Notices]
[Pages 29561-29567]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-12638]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0004]
[FDA 225-09-0012]


Memorandum of Understanding Between the Food and Drug 
Administration and Drugs.Com

AGENCY: Food and Drug Administration, HHS.

[[Page 29562]]


ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is providing notice of 
a memorandum of understanding (MOU) between FDA and Drugs.Com. The 
purpose of the MOU is to extend the reach of FDA Consumer Health 
Information and to provide consumers with better information and timely 
content concerning public health and safety topics, including alerts of 
emerging safety issues and product recalls.

DATES: The agreement became effective May 26, 2010.

FOR FURTHER INFORMATION CONTACT: Jason Brodsky, Consumer Health 
Information Staff, Office of External Relations, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5378, Silver 
Spring, MD 20993-0002, 301-796-8234, e-mail: Jason.Brodsky@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which 
states that all written agreements and MOUs between FDA and others 
shall be published in the Federal Register, the agency is publishing 
notice of this MOU.

    Dated: May 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.


[[Page 29563]]

[GRAPHIC] [TIFF OMITTED] TN26MY10.008


[[Page 29564]]


[GRAPHIC] [TIFF OMITTED] TN26MY10.009


[[Page 29565]]


[GRAPHIC] [TIFF OMITTED] TN26MY10.010


[[Page 29566]]


[GRAPHIC] [TIFF OMITTED] TN26MY10.011

[FR Doc. 2010-12638 Filed 5-25-10; 8:45 am]
BILLING CODE 4160-01-S
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.