Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Safety Communication Readership Survey, 7677-7678 [2014-02752]

Download as PDF 7677 Federal Register / Vol. 79, No. 27 / Monday, February 10, 2014 / Notices estimates that it will receive approximately 50 notifications of an intent to request special protocol assessment of a carcinogenicity protocol per year from approximately 23 sponsors. CBER estimates that it will receive approximately one notification of an intent to request special protocol assessment of a carcinogenicity protocol per year from approximately one sponsor. The hours per response, which is the estimated number of hours that a sponsor would spend preparing the notification and background information to be submitted in accordance with the guidance, is estimated to be approximately 8 hours. be posed to the Agency regarding the protocol and data, assumptions, and information needed to permit an adequate evaluation of the protocol. Based on the Agency’s experience with these submissions, FDA estimates approximately 15 hours on average would be needed per response. In the Federal Register of November 18, 2013 (78 FR 69093), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection as follows: Requests for Special Protocol Assessment. Based on the number of requests for special protocol assessment currently submitted to CDER and CBER, CDER estimates that it will receive approximately 300 requests for special protocol assessment per year from approximately 145 sponsors. CBER estimates that it will receive approximately 14 requests from approximately 11 sponsors. The hours per response is the estimated number of hours that a respondent would spend preparing the information to be submitted with a request for special protocol assessment, including the time it takes to gather and copy questions to TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity Number of responses per respondent Total annual responses Average burden per response Total hours Notification for carcinogenicity protocols ............................. Requests for special protocol assessment .......................... 24 156 2.1 2 51 314 8 15 408 4,710 Total .............................................................................. ........................ ........................ ........................ ........................ 5,118 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: February 4, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–02754 Filed 2–7–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0360] Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Safety Communication Readership Survey AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 the FDA Safety Communication Readership Survey. mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 19:25 Feb 07, 2014 Jkt 232001 Submit either electronic or written comments on the collection of information by April 11, 2014. ADDRESSES: Submit electronic comments on the collection of information to https:// 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: FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov. 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 DATES: PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 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. FDA Safety Communication (Formerly Known as Public Health Notification) Readership Survey—(OMB Control Number 0910–0341)—Extension Section 705(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 375(b)) gives FDA authority to disseminate information concerning suspected or imminent danger to public health by any regulated product. Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) also E:\FR\FM\10FEN1.SGM 10FEN1 7678 Federal Register / Vol. 79, No. 27 / Monday, February 10, 2014 / Notices authorizes FDA to conduct research relating to health information. FDA’s Center for Devices and Radiological Health (CDRH) carries out FDA’s regulatory responsibilities regarding medical devices and radiological products. CDRH must be able to effectively communicate risk to health care practitioners, patients, caregivers, and consumers when there is a real or suspected threat to the public’s health. CDRH uses safety communications to transmit information concerning these risks to user communities. Safety communications are released and available to organizations such as hospitals, nursing homes, hospices, home health care agencies, manufacturers, retail pharmacies, and other health care providers, as well as patients, caregivers, consumers, and patient advocacy groups. Through a process for identifying and addressing postmarket safety issues related to regulated products, CDRH determines when to release safety communications. FDA seeks to evaluate the clarity, timeliness, and impact of safety communications by surveying a sample of recipients to determine the impact of safety communications on the knowledge of the recipients. Understanding how the target audiences view these publications will aid in determining what, if any, changes should be considered in their content, format, and method of dissemination. The collection of this data is an important step in determining how well CDRH is communicating risk. The results from this survey will emphasize the quality of the safety communications and customer satisfaction. This will enable us to better serve the public by improving the effectiveness of safety communications. We updated the title of the survey from ‘‘FDA Public Health Notification Readership Survey’’ to ‘‘FDA Safety Communication Readership Survey’’ to accurately reflect the information that is being collected. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Activity Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Public Health Notification Readership Survey ..................... 300 3 900 0.17 (10 minutes) 153 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Based on the history of the FDA Safety Communication program, it is estimated that an average of three collections will be conducted per year. The average burden of response time is estimated at 10 minutes per survey. This was derived by CDRH staff completing the survey. Dated: February 3, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–02752 Filed 2–7–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1393] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions mstockstill on DSK4VPTVN1PROD with NOTICES AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget SUMMARY: VerDate Mar<15>2010 19:25 Feb 07, 2014 Jkt 232001 (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by March 12, 2014. 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: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0233. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov. 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. Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions—21 CFR Part 60 (OMB Control Number 0910–0233)—Extension FDA’s patent extension activities are conducted under the authority of the Drug Price Competition and Patent Term Restoration Act of 1984 (21 U.S.C. 355(j)) and the Generic Animal Drug PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 and Patent Term Restoration Act of 1988 (35 U.S.C. 156). New human drug, animal drug, human biological, medical device, food additive, or color additive products regulated by the FDA must undergo FDA safety, or safety and effectiveness, review before marketing is permitted. Where the product is covered by a patent, part of the patent’s term may be consumed during this review, which diminishes the value of the patent. In enacting the Drug Price Competition and Patent Term Restoration Act of 1984 and the Generic Animal Drug and Patent Term Restoration Act of 1988, Congress sought to encourage development of new, safer, and more effective medical and food additive products. It did so by authorizing the U.S. Patent and Trademark Office (PTO) to extend the patent term by a portion of the time during which FDA’s safety and effectiveness review prevented marketing of the product. The length of the patent term extension is generally limited to a maximum of 5 years, and is calculated by PTO based on a statutory formula. When a patent holder submits an application for patent term extension to PTO, PTO requests information from FDA, including the length of the regulatory review period for the patented product. If PTO concludes that the product is eligible for patent term extension, FDA publishes a notice that describes the length of the regulatory review period and the dates E:\FR\FM\10FEN1.SGM 10FEN1

Agencies

[Federal Register Volume 79, Number 27 (Monday, February 10, 2014)]
[Notices]
[Pages 7677-7678]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02752]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0360]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Food and Drug Administration Safety Communication 
Readership Survey

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 the FDA Safety Communication 
Readership Survey.

DATES: Submit either electronic or written comments on the collection 
of information by April 11, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to https://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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

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.

FDA Safety Communication (Formerly Known as Public Health Notification) 
Readership Survey--(OMB Control Number 0910-0341)--Extension

    Section 705(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 375(b)) gives FDA authority to disseminate information 
concerning suspected or imminent danger to public health by any 
regulated product. Section 1701(a)(4) of the Public Health Service Act 
(42 U.S.C. 300u(a)(4)) also

[[Page 7678]]

authorizes FDA to conduct research relating to health information.
    FDA's Center for Devices and Radiological Health (CDRH) carries out 
FDA's regulatory responsibilities regarding medical devices and 
radiological products. CDRH must be able to effectively communicate 
risk to health care practitioners, patients, caregivers, and consumers 
when there is a real or suspected threat to the public's health. CDRH 
uses safety communications to transmit information concerning these 
risks to user communities. Safety communications are released and 
available to organizations such as hospitals, nursing homes, hospices, 
home health care agencies, manufacturers, retail pharmacies, and other 
health care providers, as well as patients, caregivers, consumers, and 
patient advocacy groups. Through a process for identifying and 
addressing postmarket safety issues related to regulated products, CDRH 
determines when to release safety communications.
    FDA seeks to evaluate the clarity, timeliness, and impact of safety 
communications by surveying a sample of recipients to determine the 
impact of safety communications on the knowledge of the recipients. 
Understanding how the target audiences view these publications will aid 
in determining what, if any, changes should be considered in their 
content, format, and method of dissemination. The collection of this 
data is an important step in determining how well CDRH is communicating 
risk. The results from this survey will emphasize the quality of the 
safety communications and customer satisfaction. This will enable us to 
better serve the public by improving the effectiveness of safety 
communications.
    We updated the title of the survey from ``FDA Public Health 
Notification Readership Survey'' to ``FDA Safety Communication 
Readership Survey'' to accurately reflect the information that is being 
collected.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Public Health Notification Readership Survey.......................             300                3              900         0.17 (10              153
                                                                                                                              minutes)
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on the history of the FDA Safety Communication program, it is 
estimated that an average of three collections will be conducted per 
year. The average burden of response time is estimated at 10 minutes 
per survey. This was derived by CDRH staff completing the survey.

    Dated: February 3, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02752 Filed 2-7-14; 8:45 am]
BILLING CODE 4160-01-P
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