Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Reagents for Detection of Specific Novel Influenza A Viruses, 58997-58998 [2012-23544]

Download as PDF Federal Register / Vol. 77, No. 186 / Tuesday, September 25, 2012 / Notices 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 comments and suggestions submitted within 60 days of this publication. Robert Sargis, Reports Clearance Officer. [FR Doc. 2012–23528 Filed 9–24–12; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0980] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Reagents for Detection of Specific Novel Influenza A Viruses 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 guidance on reagents for detection of specific novel influenza A viruses. DATES: Submit either electronic or written comments on the collection of information by November 26, 2012. ADDRESSES: Submit electronic comments on the collection of emcdonald on DSK67QTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 14:15 Sep 24, 2012 Jkt 226001 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, 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. Guidance on Reagents for Detection of Specific Novel Influenza A Viruses— (OMB Control Number 0910–0584)— Extension In accordance with section 513 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c), FDA PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 58997 evaluated an application for an in vitro diagnostic device for detection of influenza subtype H5 (Asian lineage), commonly known as avian flu. FDA concluded that this device is properly classified into class II in accordance with 21 U.S.C. 360c(a)(1)(B), because it is a device for which the general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, but there is sufficient information to establish special controls to provide such assurance. The statute permits FDA to establish as special controls many different things, including postmarket surveillance, development and dissemination of guidance recommendations, and ‘‘other appropriate actions as the Secretary deems necessary’’ (21 U.S.C. 360c(a)(1)(B)). This information collection is a measure that FDA determined to be necessary to provide reasonable assurance of safety and effectiveness of reagents for detection of specific novel influenza A viruses. FDA issued an order classifying the H5 (Asian lineage) diagnostic device into class II on February 3, 2006, establishing the special controls necessary to provide reasonable assurance of the safety and effectiveness of that device and similar future devices. The new classification was codified in 21 CFR 866.3332, a regulation that describes the new classification for reagents for detection of specific novel influenza A viruses and sets forth the special controls that help to provide a reasonable assurance of the safety and effectiveness of devices classified under that regulation. The regulation refers to the special controls guidance document entitled ‘‘Class II Special Controls Guidance Document: Reagents for Detection of Specific Novel Influenza A Viruses,’’ which provides recommendations for measures to help provide a reasonable assurance of safety and effectiveness for these reagents. The guidance document recommends that sponsors obtain and analyze postmarket data to ensure the continued reliability of their device in detecting the specific novel influenza A virus that it is intended to detect, particularly given the propensity for influenza viruses to mutate and the potential for changes in disease prevalence over time. As updated sequences for novel influenza A viruses become available from the World Health Organization, National Institutes of Health, and other public health entities, sponsors of reagents for detection of specific novel influenza A viruses will collect this information, compare them with the primer/probe E:\FR\FM\25SEN1.SGM 25SEN1 58998 Federal Register / Vol. 77, No. 186 / Tuesday, September 25, 2012 / Notices sequences in their devices, and incorporate the result of these analyses into their quality management system, as required by 21 CFR 820.100(a)(1). These analyses will be evaluated against the device design validation and risk analysis required by 21 CFR 820.30(g), to determine if any design changes may be necessary. FDA estimates that 10 respondents will be affected annually. Each respondent will collect this information twice per year; each response is estimated to take 15 hours. This results in a total data collection burden of 300 hours. The guidance also refers to previously approved information collections found in FDA regulations. The collections of information in 21 CFR 801 have been approved under OMB control number 0910–0485; the collections of information in 21 CFR part 807 subpart E have been approved under OMB control number 0910–0120; and the collections of information in 21 CFR part 820 have been approved under OMB control number 0910–0073. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 FD&C Act section Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping 513(g) ................................................................................... 10 2 20 15 1 There Availability.’’ Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 7726, Ila.Mizrachi@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. [FR Doc. 2012–23544 Filed 9–24–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0597] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry: Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring 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 October 25, 2012. 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–New and title ‘‘Draft Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring; SUMMARY: emcdonald on DSK67QTVN1PROD with NOTICES 300 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: September 17, 2012. Leslie Kux, Assistant Commissioner for Policy. AGENCY: Total hours VerDate Mar<15>2010 14:15 Sep 24, 2012 Jkt 226001 Draft Guidance for Industry: Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring—(OMB Control Number 0910–New) Description of Respondents: Respondents to this collection of information are sponsors that monitor clinical investigations. Burden Estimate: The draft guidance is intended to assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices, and combinations thereof. The guidance is intended to make clear that sponsors can use a variety of approaches to fulfill their responsibilities related to monitoring investigator conduct and the progress of investigational new drug (IND) or investigational device exemption (IDE) studies. The guidance describes strategies for monitoring activities performed by a sponsor, or contract research organizations (CROs), that focus on the conduct, oversight, and reporting of findings of an investigation by clinical investigators. The guidance recommends strategies that reflect a risk-based approach to monitoring that focuses on critical study parameters and relies on a combination of monitoring activities to oversee a PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 study effectively. The guidance specifically encourages greater reliance on centralized monitoring methods, where appropriate. Sponsors are required to provide appropriate oversight of their clinical investigations to ensure adequate protection of the rights, welfare, and safety of human subjects and the quality and integrity of the resulting data submitted to FDA.1 As part of this oversight, sponsors of clinical investigations are required to monitor the conduct and progress of their clinical investigations.2 3 The regulations are not specific about how sponsors are to conduct monitoring of clinical investigations and, therefore, are compatible with a range of approaches to monitoring. FDA currently has OMB approval for the information collection required under part 812 (OMB control number 0910– 0078) and part 312, including certain provisions under subpart D (OMB control number 0910–0014). However, the collections of information associated with this draft guidance that are not currently approved under OMB control numbers 0910–0014 or 0910–0078 are as follows: Development of Comprehensive Monitoring Plan: Section IV.D of the draft guidance recommends that sponsors develop a prospective, detailed monitoring plan that describes the monitoring methods, responsibilities, 1 Part 312 (21 CFR part 312), subpart D, generally (Responsibilities of Sponsors and Investigators) and part 812 (21 CFR part 812), subpart C, generally (Responsibilities of Sponsors). 2 Section 312.50 requires a sponsor to, among other things, ensure ‘‘proper monitoring of the investigation(s)’’ and ‘‘that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND.’’ 3 Also see §§ 312.53(d), 312.56(a), 812.40, and 812.43(d). E:\FR\FM\25SEN1.SGM 25SEN1

Agencies

[Federal Register Volume 77, Number 186 (Tuesday, September 25, 2012)]
[Notices]
[Pages 58997-58998]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23544]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0980]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance on Reagents for Detection of Specific Novel 
Influenza A Viruses

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 guidance on reagents for 
detection of specific novel influenza A viruses.

DATES: Submit either electronic or written comments on the collection 
of information by November 26, 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, 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.

Guidance on Reagents for Detection of Specific Novel Influenza A 
Viruses--(OMB Control Number 0910-0584)--Extension

    In accordance with section 513 of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c), FDA evaluated an 
application for an in vitro diagnostic device for detection of 
influenza subtype H5 (Asian lineage), commonly known as avian flu. FDA 
concluded that this device is properly classified into class II in 
accordance with 21 U.S.C. 360c(a)(1)(B), because it is a device for 
which the general controls by themselves are insufficient to provide 
reasonable assurance of the safety and effectiveness of the device, but 
there is sufficient information to establish special controls to 
provide such assurance. The statute permits FDA to establish as special 
controls many different things, including postmarket surveillance, 
development and dissemination of guidance recommendations, and ``other 
appropriate actions as the Secretary deems necessary'' (21 U.S.C. 
360c(a)(1)(B)). This information collection is a measure that FDA 
determined to be necessary to provide reasonable assurance of safety 
and effectiveness of reagents for detection of specific novel influenza 
A viruses.
    FDA issued an order classifying the H5 (Asian lineage) diagnostic 
device into class II on February 3, 2006, establishing the special 
controls necessary to provide reasonable assurance of the safety and 
effectiveness of that device and similar future devices. The new 
classification was codified in 21 CFR 866.3332, a regulation that 
describes the new classification for reagents for detection of specific 
novel influenza A viruses and sets forth the special controls that help 
to provide a reasonable assurance of the safety and effectiveness of 
devices classified under that regulation. The regulation refers to the 
special controls guidance document entitled ``Class II Special Controls 
Guidance Document: Reagents for Detection of Specific Novel Influenza A 
Viruses,'' which provides recommendations for measures to help provide 
a reasonable assurance of safety and effectiveness for these reagents. 
The guidance document recommends that sponsors obtain and analyze 
postmarket data to ensure the continued reliability of their device in 
detecting the specific novel influenza A virus that it is intended to 
detect, particularly given the propensity for influenza viruses to 
mutate and the potential for changes in disease prevalence over time. 
As updated sequences for novel influenza A viruses become available 
from the World Health Organization, National Institutes of Health, and 
other public health entities, sponsors of reagents for detection of 
specific novel influenza A viruses will collect this information, 
compare them with the primer/probe

[[Page 58998]]

sequences in their devices, and incorporate the result of these 
analyses into their quality management system, as required by 21 CFR 
820.100(a)(1). These analyses will be evaluated against the device 
design validation and risk analysis required by 21 CFR 820.30(g), to 
determine if any design changes may be necessary.
    FDA estimates that 10 respondents will be affected annually. Each 
respondent will collect this information twice per year; each response 
is estimated to take 15 hours. This results in a total data collection 
burden of 300 hours. The guidance also refers to previously approved 
information collections found in FDA regulations. The collections of 
information in 21 CFR 801 have been approved under OMB control number 
0910-0485; the collections of information in 21 CFR part 807 subpart E 
have been approved under OMB control number 0910-0120; and the 
collections of information in 21 CFR part 820 have been approved under 
OMB control number 0910-0073.
    FDA estimates the burden of this collection of information as 
follows:

                                Table 1--Estimated Annual Recordkeeping Burden 1
----------------------------------------------------------------------------------------------------------------
                                                  Number of                      Average  burden
      FD&C Act section           Number of       records per      Total annual         per          Total hours
                               recordkeepers     recordkeeper       records       recordkeeping
----------------------------------------------------------------------------------------------------------------
513(g)......................              10                2               20               15              300
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: September 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-23544 Filed 9-24-12; 8:45 am]
BILLING CODE 4160-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.