Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of “Health Care Providers' Responses to Medical Device Labeling”, 67459-67460 [2011-28241]

Download as PDF Federal Register / Vol. 76, No. 211 / Tuesday, November 1, 2011 / Notices Dated: October 25, 2011. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. Dated: October 25, 2011. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2011–28221 Filed 10–31–11; 8:45 am] [FR Doc. 2011–28219 Filed 10–31–11; 8:45 am] BILLING CODE 4163–18–P BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Food and Drug Administration Advisory Council for the Elimination of Tuberculosis (ACET) Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of ‘‘Health Care Providers’ Responses to Medical Device Labeling’’ [Docket No. FDA–2011–N–0766] srobinson on DSK4SPTVN1PROD with NOTICES In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the following meeting of the aforementioned committee: Times and Dates: 8:30 a.m.–5:30 p.m., December 6, 2011. 8:30 a.m.–2:30 p.m., December 7, 2011. Place: Corporate Square, Building 8, 1st Floor Conference Room, Atlanta, Georgia 30333, telephone (404) 639–8317. Status: Open to the public, limited only by the space available. The meeting room accommodates approximately 100 people. Purpose: This council advises and makes recommendations to the Secretary of Health and Human Services, the Assistant Secretary for Health, and the Director, CDC, regarding the elimination of tuberculosis. Specifically, the Council makes recommendations regarding policies, strategies, objectives, and priorities; addresses the development and application of new technologies; and reviews the extent to which progress has been made toward eliminating tuberculosis. Matters to be Discussed: Agenda items include issues pertaining to the future directions of tuberculosis control and elimination in the United States: (1) STOP TB USA; (2) Institute of Medicine Report; and (3) The Restructuring of United States Tuberculosis Program (TRUST); Update on ACET Workgroups; and other related tuberculosis issues. Agenda items are subject to change as priorities dictate. Contact Person For More Information: Margie Scott-Cseh, Centers for Disease Control and Prevention, 1600 Clifton Road NE., M/S E–07, Atlanta, Georgia 30333, telephone (404) 639–8317. 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 the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. VerDate Mar<15>2010 17:04 Oct 31, 2011 Jkt 226001 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on this proposed information collection ‘‘Health Care Providers’ Responses to Medical Device Labeling.’’ DATES: Submit either electronic or written comments on the collection of information by January 3, 2012. 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: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, (301) 796– 5156, Daniel.Gittleson@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 SUMMARY: PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 67459 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 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. Survey of ‘‘Health Care Providers’ Responses to Medical Device Labeling’’—21 CFR Part 801 (OMB Control Number 0910–New) The purpose of this study is to determine the most effective device labeling format and inform an FDA’s regulatory approach on standardized device labeling. Building upon the research methodology and success of the approach FDA used to evaluate drug labeling, we propose to ask health care providers (HCPs) to evaluate the quality of labeling (e.g. instructions for use, directions) for a medical device and to report the degree to which they could follow those instructions, how useful the information is, and how well organized the information is. This work will allow FDA to assess whether HCPs find the format and content of device labeling clear, understandable, useful, and user-friendly. Findings will provide evidence to inform FDA’s regulatory approach to standardizing medical device labeling across the United States. FDA estimates the burden of this collection of information as follows: E:\FR\FM\01NON1.SGM 01NON1 67460 Federal Register / Vol. 76, No. 211 / Tuesday, November 1, 2011 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents Respondents Average burden per response Total annual responses Total hours Interviews Physicians ............................................................................ Advanced practice nurses (NPs) and registered nurses ..... Medical technicians .............................................................. 6 9 9 1 1 1 6 9 9 1 1 1 6 9 9 Subtotal ......................................................................... 24 1 24 1 24 Survey Physicians ............................................................................ Advanced practice nurses (NPs) and registered nurses ..... Medical technicians .............................................................. 120 240 240 1 1 1 120 240 240 .5 .5 .5 60 120 120 Total .............................................................................. ........................ ........................ ........................ ........................ 324 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: October 26, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–28241 Filed 10–31–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0554] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Veterinary Feed Directive 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 (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by December 1, 2011. SUMMARY: 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 0910–0363. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, (301) 796–7651, juanmanuel.vilela@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. ADDRESSES: Veterinary Feed Directive—21 CFR Part 558 (OMB Control Number 0910– 0363)—(Extension) With the passage of the Animal Drug Availability Act of 1996 (ADAA) (Pub. L. 104–250), the Congress enacted legislation establishing a new class of restricted feed use drugs, veterinary feed directive (VFD) drugs, which may be distributed without involving State pharmacy laws. Although controls on the distribution and use of VFD drugs are similar to those for prescription drugs regulated under section 503(f) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 353(f)), the implementing VFD regulation (21 CFR 558.6) is tailored to the unique circumstances relating to the distribution of medicated feeds. The content of the VFD is spelled out in the regulation. All distributors of medicated feed containing VFD drugs must notify FDA of their intent to distribute, and records must be maintained of the distribution of all medicated feeds containing VFD drugs. The VFD regulation ensures the protection of public health while enabling animal producers to obtain and use needed drugs as efficiently and costeffectively as possible. In the Federal Register of August 3, 2011(76 FR 46818), FDA published a 60day notice requesting public comment on the proposed collection of information. FDA received no comments that pertained to the information collection burden estimates. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents srobinson on DSK4SPTVN1PROD with NOTICES 21 CFR section 558.6(a)(3) through (a)(5) .............................................. 558.6(d)(1)(i) through (d)(1)(iii) ...................................... 558.6(d)(1)(iv) ................................................................ 558.6(d)(2) ..................................................................... 514.1(b)(9) ..................................................................... VerDate Mar<15>2010 19:00 Oct 31, 2011 Jkt 226001 PO 00000 Frm 00059 Number of responses per respondent 15,000 300 20 1,000 1 Fmt 4703 25 1 1 5 1 Sfmt 4703 Total annual responses Average burden per response 375,000 300 20 5,000 1 E:\FR\FM\01NON1.SGM 01NON1 .25 .25 .25 .25 3 Total hours 93,750 75 5 1,250 3

Agencies

[Federal Register Volume 76, Number 211 (Tuesday, November 1, 2011)]
[Notices]
[Pages 67459-67460]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28241]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0766]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Survey of ``Health Care Providers' Responses to 
Medical Device Labeling''

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 and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on this proposed information collection 
``Health Care Providers' Responses to Medical Device Labeling.''

DATES: Submit either electronic or written comments on the collection 
of information by January 3, 2012.

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: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, (301) 796-5156, 
Daniel.Gittleson@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 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.

Survey of ``Health Care Providers' Responses to Medical Device 
Labeling''--21 CFR Part 801 (OMB Control Number 0910-New)

    The purpose of this study is to determine the most effective device 
labeling format and inform an FDA's regulatory approach on standardized 
device labeling. Building upon the research methodology and success of 
the approach FDA used to evaluate drug labeling, we propose to ask 
health care providers (HCPs) to evaluate the quality of labeling (e.g. 
instructions for use, directions) for a medical device and to report 
the degree to which they could follow those instructions, how useful 
the information is, and how well organized the information is. This 
work will allow FDA to assess whether HCPs find the format and content 
of device labeling clear, understandable, useful, and user-friendly. 
Findings will provide evidence to inform FDA's regulatory approach to 
standardizing medical device labeling across the United States.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 67460]]



                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
           Respondents               Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
                                                   Interviews
----------------------------------------------------------------------------------------------------------------
Physicians......................               6               1               6               1               6
Advanced practice nurses (NPs)                 9               1               9               1               9
 and registered nurses..........
Medical technicians.............               9               1               9               1               9
                                 -------------------------------------------------------------------------------
    Subtotal....................              24               1              24               1              24
----------------------------------------------------------------------------------------------------------------
                                                     Survey
----------------------------------------------------------------------------------------------------------------
Physicians......................             120               1             120              .5              60
Advanced practice nurses (NPs)               240               1             240              .5             120
 and registered nurses..........
Medical technicians.............             240               1             240              .5             120
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             324
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: October 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-28241 Filed 10-31-11; 8:45 am]
BILLING CODE 4160-01-P
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