Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Notice of Participation, 13602-13603 [E6-3819]

Download as PDF 13602 Federal Register / Vol. 71, No. 51 / Thursday, March 16, 2006 / Notices TABLE 4.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued 21 CFR Section No. of Recordkeepers No. of Responses per Recordkeeper Total Annual Records Hours per Record 203.31(d)(1) and (d)(2) 2,208 1 2,208 40.00 88,320 442 1 442 24.00 10,608 203.31(e) 2,208 1 2,208 1.00 2,208 203.34 2,208 1 2,208 40.00 88,320 203.37(a) 25 1 25 18.00 450 203.37(b) 200 1 200 18.00 3,600 203.39(d) 65 1 65 1.00 65 203.39(e) 3,221 1 3,221 .50 1,610 203.39(f) 3,221 1 3,221 8.00 25,768 203.39(g) 3,221 1 3,221 8.00 25,768 203.50(a) 0 0 0 0 0 203.50(b) 0 0 0 0 0 203.50(d) 0 0 0 0 0 203.31(d)(4) Total Recordkeeping Burden Hours 1There 409,409 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: March 10, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–3818 Filed 3–15–06; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N–0426] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Notice of Participation AGENCY: 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 April 17, 2006. wwhite on PROD1PC61 with NOTICES SUMMARY: VerDate Aug<31>2005 15:48 Mar 15, 2006 Jkt 208001 OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. 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: Fumie Yokota, Desk Officer for FDA, FAX: 202–395–6974. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–4659. 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: BILLING CODE 4160–01–S ACTION: Total Hours Notice of Participation—(OMB Control Number 0910–0191)—Extension Section 12.45 (21 CFR 12.45), issued under section 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371), sets forth the format and procedures for any interested person to file a petition to participate in a formal evidentiary hearing, either personally or through a representative. Section 12.45 requires that any person filing a notice of PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 participation state their specific interest in the proceedings, including the specific issues of fact about which the person desires to be heard. This section also requires that the notice include a statement that the person will present testimony at the hearing and will comply with specific requirements in § 12.85, or, in the case of a hearing before a Public Board of Inquiry (21 CFR 13.25). In accordance with § 12.45(e) the presiding officer may omit a participant’s appearance. The presiding officer and other participants will use the collected information in a hearing to identify specific interests to be presented. This preliminary information serves to expedite the pre-hearing conference and commits participation. The respondents are individuals or households, State or local governments, not for profit institutions, and businesses, or other for profit groups and institutions. In the Federal Register of November 1, 2005 (70 FR 65904), FDA published a 60-day notice requesting public comment on the information collection provisions to which one comment was received. However, it was not related to the information collection. E:\FR\FM\16MRN1.SGM 16MRN1 13603 Federal Register / Vol. 71, No. 51 / Thursday, March 16, 2006 / Notices TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents 21 CFR Section 12.45 264 1 There DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N–0422] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emergency Shortages Data Collection System (Formerly the Emergency Medical Device Shortage Program Survey) Food and Drug Administration, HHS. 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. Fax written comments on the collection of information by April 17, 2006. DATES: OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. 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: Fumie Yokota, Desk Officer for FDA, FAX: 202–395–6974. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–4659. wwhite on PROD1PC61 with NOTICES 1 Hours per Response 264 Emergency Shortages Data Collection System (Formerly the Emergency Medical Device Shortage Program Survey)—(OMB Control Number 0910– 0491)—Extension BILLING CODE 4160–01–S AGENCY: Total Annual Responses Total Hours 3 792 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: March 10, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–3819 Filed 3–15–06; 8:45 am] ACTION: Annual Frequency per Response 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: VerDate Aug<31>2005 15:48 Mar 15, 2006 Jkt 208001 Under section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 393(d)(2)), the Commissioner of Food and Drugs is authorized to implement general powers (including conducting research) to carry out effectively the mission of FDA. Section 510 of the act (21 U.S.C. 360) requires that domestic establishments engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for human use and commercial distribution register their establishments and list the devices they manufacture with FDA. Section 522 of the act (21 U.S.C. 360(l)) authorizes FDA to require manufacturers to conduct postmarket surveillance of medical devices. Section 705(b) of the act (21 U.S.C. 375(b)) authorizes FDA to collect and disseminate information regarding medical products or cosmetics in situations involving imminent danger to health, or gross deception of the consumer. These sections of the act enable FDA to enhance consumer protection from risks associated with medical device usage that are not foreseen or apparent during the premarket notification and review process. Subsequent to the events of September 11, 2001, FDA’s Center for Devices and Radiological Health (CDRH) began planning for handling medical device shortage issues associated with counter-terrorism. One of the activities related to the planning was that CDRH would establish a data collection system as a supplemental source for available product. Because of events on September 11, 2001, local and State governments have obtained stockpiles of backup supplies within their jurisdiction to cover an emergency for the first 12 hours following a terrorist attack. The second 12 hours will have additional medical devices supplied by the Centers for Disease Control’s Strategic National Stockpile and the National Acquisition Center. However, if additional supplies are needed in the first 12 hours, the Department of Health PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 and Human Services (HHS) will request that FDA provide the number of medical devices readily available to meet demands. HHS has an established transportation and delivery mechanism in place to provide these emergent needs to the local and State authorities. The Emergency Medical Device Shortage Survey was established in 1992 to collect data to assist FDA in implementing an emergency medical device shortage program that would find resources to supplement the needed supplies. In 2004, CDRH changed the process for the data collection and the name was changed to the Emergency Shortages Data Collection System. Because of the confidentiality aspect of the information, the information is only available to those on FDA’s Emergency Shortage Team (EST) and senior management with a need-to-know. The need-to-know personnel include five EST members, the EST leader, the EST data entry technician, and five senior managers. The Emergency Shortages Data Collection System will be updated every 4 months to keep information current. CDRH learned that medical device manufacturers have a high rate of turnover in personnel and in corporate structures due to mergers with larger companies. In addition, with the constant advances in technology, some of these manufacturers are forced to discontinue product lines or add product lines to their inventory. This new data collection system process will update information on a regular basis ensuring more accurate information in an emergency/disaster. The process consists of one scripted telephone call to the designated shortage person at the four or five largest manufacturers of specific medical devices that may be needed by first responders in a national emergency. At the current time, the list contains 67 products from 65 manufacturers. If other products or new technology are deemed necessary to add at a later date, then the EST will conduct the appropriate search to find the four or five largest manufacturers of that product line and request the manufacturer’s voluntary inclusion into the program. The Emergency Shortages Data Collection System will only include E:\FR\FM\16MRN1.SGM 16MRN1

Agencies

[Federal Register Volume 71, Number 51 (Thursday, March 16, 2006)]
[Notices]
[Pages 13602-13603]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-3819]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0426]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Notice of 
Participation

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 April 
17, 2006.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4659.

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.

Notice of Participation--(OMB Control Number 0910-0191)--Extension

    Section 12.45 (21 CFR 12.45), issued under section 701 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371), sets forth the 
format and procedures for any interested person to file a petition to 
participate in a formal evidentiary hearing, either personally or 
through a representative. Section 12.45 requires that any person filing 
a notice of participation state their specific interest in the 
proceedings, including the specific issues of fact about which the 
person desires to be heard. This section also requires that the notice 
include a statement that the person will present testimony at the 
hearing and will comply with specific requirements in Sec.  12.85, or, 
in the case of a hearing before a Public Board of Inquiry (21 CFR 
13.25). In accordance with Sec.  12.45(e) the presiding officer may 
omit a participant's appearance.
    The presiding officer and other participants will use the collected 
information in a hearing to identify specific interests to be 
presented. This preliminary information serves to expedite the pre-
hearing conference and commits participation.
    The respondents are individuals or households, State or local 
governments, not for profit institutions, and businesses, or other for 
profit groups and institutions.
    In the Federal Register of November 1, 2005 (70 FR 65904), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions to which one comment was received. However, it 
was not related to the information collection.

[[Page 13603]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
12.45                            264                  1                264                  3                792
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: March 10, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-3819 Filed 3-15-06; 8:45 am]
BILLING CODE 4160-01-S
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