Proposed Information Collection Activity; Comment Request Proposed Projects, 18917-18918 [2014-07530]

Download as PDF 18917 Federal Register / Vol. 79, No. 65 / Friday, April 4, 2014 / Notices verification is required for psychiatric hospitals. Some verification is needed, however, to ensure that other types of hospitals and units meet the criteria for exclusion. Consequently, we instructed the Fiscal Intermediaries (FIs) and SAs to perform certain verification activities, beginning in October 1983 when PPS was implemented. We originally developed the CMS–437 as an SA Worksheet for verifying exclusions from PPS for psychiatric units. Since April 9, 1994, PPS-excluded psychiatric units already excluded from the PPS have met CMS’s annual requirement for PPS-exclusion by selfattesting that they remain in compliance with the PPS exclusion criteria. Under the current procedure, all psychiatric units applying for first-time exclusion are surveyed by the SAs. The SAs also perform surveys to investigate complaint allegations and conduct annual sample reverification surveys on 5 percent of all psychiatric units. The aforementioned exclusions continue to exist and thus we propose to continue to use the Criteria Worksheet, Forms CMS–437, for verifying first-time exclusions from the PPS, for complaint surveys, for its annual 5 percent validation sample, and for facility selfattestation. These forms are related to the survey and certification and Medicare approval of the PPS-excluded units. Form Number: CMS–437 (OCN: 0938–0358); Frequency: Annually; Affected Public: Private sector— Business or other for-profits; Number of Respondents: 1,614; Total Annual Responses: 1,614; Total Annual Hours: Dated: April 1, 2014. Martique Jones, Deputy Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. 404. (For policy questions regarding this collection contact Donald Howard at 410–786–6764.) 2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Disclosure for the In-Office Ancillary Services Exception; Use: Physicians who provide certain imaging services (magnetic resonance imaging, computed tomography, and positron emission tomography) under the in-office ancillary services exception to the physician self-referral prohibition are required to create the disclosure notice as well as the list of other imaging suppliers to be provided to the patient. The patient will then be able to use the disclosure notice and list of suppliers in making an informed decision about his or her course of care for the imaging service. The physician must maintain a record of the disclosure in the patient’s medical record. If we were investigating the referrals of a physician providing advanced imaging services under the inoffice ancillary services exception, we would review the written disclosure in order to determine if the physician satisfied the requirement. Form Number: CMS–10332 (OCN: 0938– 1133); Frequency: Occasionally; Affected Public: Private sector— Business or other for-profits; Number of Respondents: 71,000; Total Annual Responses: 71,106; Total Annual Hours: 125,383. (For policy questions regarding this collection contact Jacqueline Proctor at 410–786–8852). [FR Doc. 2014–07582 Filed 4–3–14; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects Title: Family Violence Prevention and Services: Grants to States; Native American Tribes and Alaskan Native Villages; and State Domestic Violence Coalitions OMB No.: 0970–0280 Description: The Family Violence Prevention and Services Act (FVPSA), 42 U.S.C. 10401 et seq., authorizes the Department of Health and Human Services to award grants to States, Tribes—and Tribal Organizations, and State Domestic Violence Coalitions for family violence prevention and intervention activities. The proposed information collection activities will be used to make grant award decisions and to monitor grant performance. Respondents: State Agencies Administering FVPSA Grants; Tribal Governments and Tribal Organizations; and State Domestic Violence Coalitions. ANNUAL BURDEN ESTIMATES Number of responses per respondent Number of respondents Instrument Average burden hours per response Total burden hours 53 150 56 53 150 56 1 1 1 1 1 1 10 5 10 10 10 10 530 750 560 530 1,500 560 Estimated Total Annual Burden Hours ..................................................... mstockstill on DSK4VPTVN1PROD with NOTICES State Grant Application .................................................................................... Tribal Grant Application ................................................................................... State Domestic Violence Coalition Application ................................................ State FVPSA Grant Performance Progress Report ........................................ Tribal FVPSA Grant Performance Progress Report ........................................ State Domestic Violence Coalition Performance Progress Report ................. ........................ ........................ ........................ 4,430 In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research VerDate Mar<15>2010 17:37 Apr 03, 2014 Jkt 232001 and Evaluation, 370 L’Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email address: infocollection@ acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to E:\FR\FM\04APN1.SGM 04APN1 18918 Federal Register / Vol. 79, No. 65 / Friday, April 4, 2014 / Notices comments and suggestions submitted within 60 days of this publication. Robert Sargis, Reports Clearance Officer. [FR Doc. 2014–07530 Filed 4–3–14; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–0147] Types of Communication During the Review of Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Types of Communication During the Review of Medical Device Submissions.’’ The purpose of this guidance is to update the Agency’s approach to Interactive Review and other additional types of communication, to reflect FDA’s implementation of the Medical Device User Fee Act of 2007 (MDUFA II) Commitment Letters and of undertakings agreed to in connection with the Medical Device User Fee Amendments of 2012 (MDUFA III). These new Agency communication commitments are to increase the efficiency of the review process. DATES: Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. ADDRESSES: An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for single copies of the guidance document entitled ‘‘Types of Communication During the Review of Medical Device Submissions’’ to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002 or the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Administration, 1401 mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:37 Apr 03, 2014 Jkt 232001 Rockville Pike, Suite 200N, Rockville, MD 20852–1448. Send one selfaddressed adhesive label to assist that office in processing your request, or fax your request to 301–847–8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Samie Allen, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1533, Silver Spring, MD 20993–0002, 301–796–6055, or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: I. Background In the letters dated September 27, 2007, from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the U.S. Senate and the Chairman of the Committee on Energy and Commerce of the U.S. House of Representatives setting out the goals of section 201(c) of MDUFA II, Title II of the Food and Drug Administration Amendments of 2007 (FDAAA) (21 U.S.C. 379i note), FDA committed to developing a guidance document that describes an interactive review process between FDA and industry for specific medical device premarket submissions. Further, during discussions with representatives of the medical device industry in the development of the Agency’s recommendations for MDUFA III, Title II of the Food and Drug Administration Safety and Innovation Act, Public Law 112–144 (July 9, 2012) (21 U.S.C. 301 note), the Agency proposed process improvements to provide further transparency into the review process, including new communication commitments. In the Federal Register on March 5, 2013 (78 FR 14305), FDA announced the availability of the draft guidance document. Interested persons were invited to comment by June 3, 2013. Four comments were received and, in general, were supportive of the guidance. However, the comments contained multiple recommendations PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 pertaining to the content of the guidance and the need for clarification, particularly for the Interactive Review section. In response to these comments, FDA revised the guidance document to restructure the Interactive Review section to clarify how this process works and to include references to additional submission types for which Interactive Review pertains. Although several commenters expressed concern about FDA’s intention to limit the last round of Interactive Review to 7 days, we did not modify the guidance because this approach is needed in order to appropriately balance the intent of interactive review with FDA’s commitment to meet the performance goals agreed upon as part of MDUFA III. In response to comments regarding our intention to limit the issuance of second Additional Information (AI) letters for 510(k) submissions, the guidance was modified slightly to clarify the circumstances in which a second AI letter might be issued, but remains unchanged in explaining that these circumstances will remain limited and at FDA’s discretion. FDA will continually assess any impacts that the limited use of a second AI letter may have, and, if needed, may consider modifications to this approach. In addition to modifications to the Interactive Review section, we clarified other items throughout the guidance, and included Pre-Submissions as a submission type subject to Acceptance Communication. This document supersedes ‘‘Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements’’ dated February 28, 2008. II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s current thinking on communication during a medical device premarket submission review to provide further transparency into, and to increase the efficiency of, the review process. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by using the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at http://www.fda.gov/MedicalDevices/ E:\FR\FM\04APN1.SGM 04APN1

Agencies

[Federal Register Volume 79, Number 65 (Friday, April 4, 2014)]
[Notices]
[Pages 18917-18918]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07530]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Proposed Information Collection Activity; Comment Request 
Proposed Projects

    Title: Family Violence Prevention and Services: Grants to States; 
Native American Tribes and Alaskan Native Villages; and State Domestic 
Violence Coalitions
    OMB No.: 0970-0280
    Description: The Family Violence Prevention and Services Act 
(FVPSA), 42 U.S.C. 10401 et seq., authorizes the Department of Health 
and Human Services to award grants to States, Tribes--and Tribal 
Organizations, and State Domestic Violence Coalitions for family 
violence prevention and intervention activities. The proposed 
information collection activities will be used to make grant award 
decisions and to monitor grant performance.
    Respondents: State Agencies Administering FVPSA Grants; Tribal 
Governments and Tribal Organizations; and State Domestic Violence 
Coalitions.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
                   Instrument                        Number of     responses per     hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
State Grant Application.........................              53               1              10             530
Tribal Grant Application........................             150               1               5             750
State Domestic Violence Coalition Application...              56               1              10             560
State FVPSA Grant Performance Progress Report...              53               1              10             530
Tribal FVPSA Grant Performance Progress Report..             150               1              10           1,500
State Domestic Violence Coalition Performance                 56               1              10             560
 Progress Report................................
                                                 ---------------------------------------------------------------
    Estimated Total Annual Burden Hours.........  ..............  ..............  ..............           4,430
----------------------------------------------------------------------------------------------------------------

    In compliance with the requirements of Section 506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Administration for Children and 
Families is soliciting public comment on the specific aspects of the 
information collection described above. Copies of the proposed 
collection of information can be obtained and comments may be forwarded 
by writing to the Administration for Children and Families, Office of 
Planning, Research and Evaluation, 370 L'Enfant Promenade SW., 
Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email 
address: infocollection@acf.hhs.gov. All requests should be identified 
by the title of the information collection.
    The Department specifically requests comments on: (a) Whether the 
proposed collection of information is necessary for the proper 
performance of the functions of the agency, including whether the 
information shall have practical utility; (b) the accuracy of the 
agency's estimate of the burden of the proposed collection of 
information; (c) the quality, utility, and clarity of the information 
to be collected; and (d) ways to minimize the burden of the collection 
of information on respondents, including through the use of automated 
collection techniques or other forms of information technology. 
Consideration will be given to

[[Page 18918]]

comments and suggestions submitted within 60 days of this publication.

Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014-07530 Filed 4-3-14; 8:45 am]
BILLING CODE 4184-01-P