Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in the Medical Device Fellowship Program, 4913-4914 [2011-1760]

Download as PDF 4913 Federal Register / Vol. 76, No. 18 / Thursday, January 27, 2011 / Notices ANNUAL BURDEN ESTIMATES Number of responses per respondent Number of respondents Instrument Average burden hours per response Total burden hours 1099 Record specification ............................................................. IRS Safeguarding Certification Letter ............................................ 54 54 12 1 1.96 0.48 Estimated Total Annual Burden Hours ................................... ............................ ............................ ............................ In compliance with the requirements of Section 3506(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 Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACE Reports Clearance Officer. E-mail 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 comments and suggestions submitted within 60 days of this publication. Dated: January 18, 2011. Robert Sargis, Reports Clearance Officer. Food and Drug Administration Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in the Medical Device Fellowship Program Food and Drug Administration, HHS. 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 February 28, 2011. 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 0910–0551. Also include the FDA docket number found in brackets in the heading of this document. SUMMARY: FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of Information Management, Food and Drug [FR Doc. 2011–1532 Filed 1–26–11; 8:45 am] BILLING CODE 4184–01–M In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: [Docket No. FDA–2010–N–0544] ACTION: 1,296 Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 5156, Daniel.Gittleson@fda.hhs.gov. DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: 1,270.08 25.92 Application for Participation in the Medical Device Fellowship Program— (OMB Control Number 0910–0551)— Extension Sections 1104, 1302, 3301, 3304, 3320, 3361, 3393, and 3394 of Title 5 of the United States Code authorize Federal Agencies to rate applicants for Federal jobs. Collecting applications for the Medical Device Fellowship Program will allow FDA’s Center for Devices and Radiological Health (CDRH) to easily and efficiently elicit and review information from students and health care professionals who are interested in becoming involved in CDRH activities. The process will reduce the time and cost of submitting written documentation to the Agency and lessen the likelihood of applications being misrouted within the Agency mail system. It will assist the Agency in promoting and protecting the public health by encouraging outside persons to share their expertise with CDRH. In the Federal Register of October 27, 2010 (75 FR 66103), 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 of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 mstockstill on DSKH9S0YB1PROD with NOTICES 5 U.S.C. Section FDA Form No. 1104, 1302, 3301, 3304, 3320, 3361, 3393, 3394 1 There Number of respondents 3608 Annual frequency per response 250 1 Total annual responses Hours per response 250 are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Mar<15>2010 17:51 Jan 26, 2011 Jkt 223001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\27JAN1.SGM 27JAN1 Total hours 1 250 4914 Federal Register / Vol. 76, No. 18 / Thursday, January 27, 2011 / Notices FDA based these estimates on the number of inquiries that have been received concerning the program and the number of requests for application forms over the past 3 years. Dated: January 19, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–1760 Filed 1–26–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0042] Agency Information Collection Activities: Proposed Collection; Comment Request; Investigational New Drug Regulations 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 requirements under which the clinical investigation of the safety and effectiveness of unapproved new drugs and biological products can be conducted. DATES: Submit either electronic or written comments on the collection of information by March 28, 2011. 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: Elizabeth Berbakos, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., P150–400B, Rockville, MD 20850. 301– 796–3792. Elizabeth.Berbakos@fda.hhs.gov. mstockstill on DSKH9S0YB1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:51 Jan 26, 2011 Jkt 223001 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. SUPPLEMENTARY INFORMATION: Investigational New Drug (IND) Regulations—21 CFR Part 312 (OMB Control Number 0910–0014)—Extension FDA is requesting OMB approval for the reporting and recordkeeping requirements contained in the FDA regulations ‘‘Investigational New Drug Application’’ in part 312 (21 CFR part 312). Part 312 implements provisions of section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) (the FD&C Act) to issue regulations under which the clinical investigation of the safety and effectiveness of unapproved new drugs and biological products can be conducted. FDA is charged with implementing statutory requirements that drug products marketed in the United States be shown to be safe and effective, properly manufactured, and properly labeled for their intended uses. Section 505(a) of the act provides that a new drug may not be introduced or delivered PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 for introduction into interstate commerce in the United States unless FDA has previously approved a new drug application (NDA). FDA approves an NDA only if the sponsor of the application first demonstrates that the drug is safe and effective for the conditions prescribed, recommended, or suggested in the product’s labeling. Proof must consist, in part, of adequate and well-controlled studies, including studies in humans, that are conducted by qualified experts. The IND regulations establish reporting requirements that include an initial application as well as amendments to that application, reports on significant revisions of clinical investigation plans, and information on a drug’s safety or effectiveness. In addition, the sponsor is required to give FDA an annual summary of the previous year’s clinical experience. Submissions are reviewed by medical officers and other agency scientific reviewers assigned responsibility for overseeing the specific study. The IND regulations also contain recordkeeping requirements that pertain to the responsibilities of sponsors and investigators. The detail and complexity of these requirements are dictated by the scientific procedures and human subject safeguards that must be followed in the clinical tests of investigational new drugs. The IND information collection requirements provide the means by which FDA can do the following: (1) Monitor the safety of ongoing clinical investigations; (2) determine whether the clinical testing of a drug should be authorized; (3) ensure production of reliable data on the metabolism and pharmacological action of the drug in humans; (4) obtain timely information on adverse reactions to the drug; (5) obtain information on side effects associated with increasing doses; (6) obtain information on the drug’s effectiveness; (7) ensure the design of well-controlled, scientifically valid studies; (8) obtain other information pertinent to determining whether clinical testing should be continued and information related to the protection of human subjects. Without the information provided by industry in response to the IND regulations, FDA cannot authorize or monitor the clinical investigations which must be conducted prior to authorizing the sale and general use of new drugs. These reports enable FDA to monitor a study’s progress, to assure subject safety, to assure that a study will be conducted ethically, and to increase the likelihood that the sponsor will conduct studies that will be useful in determining whether the E:\FR\FM\27JAN1.SGM 27JAN1

Agencies

[Federal Register Volume 76, Number 18 (Thursday, January 27, 2011)]
[Notices]
[Pages 4913-4914]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1760]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0544]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Application for 
Participation in the Medical Device Fellowship Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: 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 
February 28, 2011.

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 0910-0551. 
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Application for Participation in the Medical Device Fellowship 
Program--(OMB Control Number 0910-0551)--Extension

    Sections 1104, 1302, 3301, 3304, 3320, 3361, 3393, and 3394 of 
Title 5 of the United States Code authorize Federal Agencies to rate 
applicants for Federal jobs. Collecting applications for the Medical 
Device Fellowship Program will allow FDA's Center for Devices and 
Radiological Health (CDRH) to easily and efficiently elicit and review 
information from students and health care professionals who are 
interested in becoming involved in CDRH activities. The process will 
reduce the time and cost of submitting written documentation to the 
Agency and lessen the likelihood of applications being misrouted within 
the Agency mail system. It will assist the Agency in promoting and 
protecting the public health by encouraging outside persons to share 
their expertise with CDRH.
    In the Federal Register of October 27, 2010 (75 FR 66103), 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 of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of     Annual frequency    Total annual        Hours per
              5 U.S.C. Section                  FDA Form No.       respondents      per response        responses         response         Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1104, 1302, 3301, 3304, 3320, 3361, 3393,                 3608               250                 1               250                 1               250
 3394.......................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 4914]]

    FDA based these estimates on the number of inquiries that have been 
received concerning the program and the number of requests for 
application forms over the past 3 years.

    Dated: January 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-1760 Filed 1-26-11; 8:45 am]
BILLING CODE 4160-01-P
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