Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices, 32987-32988 [E6-8838]

Download as PDF Federal Register / Vol. 71, No. 109 / Wednesday, June 7, 2006 / Notices 32987 TABLE 1.—COEFFICIENTS (WEIGHTS) FOR THE MEASURES INCLUDED IN THE PERMANENCY-RELATED DATA COMPOSITES— Continued Components Composites and variables Component 1 Children in foster care for 24 or more months who achieve permanency in less than 12 months. Permanent homes for children who are legally freed for adoption Children emancipated from foster care who were in foster care for 3 years or longer. Permanency Composite 4: Placement stability .................................... Placement stability for children in foster care for less than 24 months. Placement stability for children in foster care between 12 and 24 months. Placement stability for children in foster care for 24 months or longer. [FR Doc. 06–5193 Filed 6–6–06; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N–0220] Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices AGENCY: Food and Drug Administration, HHS. rwilkins on PROD1PC63 with NOTICES 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 information collection requirements for Administrative Detention and Banned Medical Devices. DATES: Submit written or electronic comments on the collection of information by August 7, 2006. ADDRESSES: Submit electronic comments on the collection of information to: https://www.fda.gov/ dockets/ecomments. 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 VerDate Aug<31>2005 17:54 Jun 06, 2006 Jkt 208001 0.468 .......................... 0.804 .......................... ¥0.146 ....................... ¥0.244. 0.922. Placement stability ..... Not applicable for composite. Frm 00075 Component 3 0.274. Not applicable for composite. 0.399. 0.421. 0.398. comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1472. 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 PO 00000 Component 2 Fmt 4703 Sfmt 4703 collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Administrative Detention and Banned Medical Devices—(OMB Control Number 0910–0114)—Extension The Food and Drug Administration (FDA) has the statutory authority under section 304(g) of the Federal Food, Drug and Cosmetic Act (the act) (21 U.S.C. 334(g)), where officers or employees duly designated by the Secretary (FDA investigators) may detain devices during establishment inspections which are believed to be adulterated or misbranded. On March 9, 1979, FDA issued, under § 800.55 (21 CFR 800.55), a final regulation on Administrative Detention Procedures (44 FR 13234), under section 304(g) of the act, which includes certain reporting requirements (§ 800.55(g)(1) and (g)(2)) and recordkeeping requirements (§ 800.55(k)). Under § 800.55(g), an appellant of a detention order must show documentation of ownership if devices are detained at a place other than that of the appellant. Under § 800.55(k), the owner or other responsible person must supply records about how the devices may have become adulterated or misbranded, as well as records of distribution of the detained devices. These recordkeeping requirements for administrative detentions allow FDA to trace devices for which the detention period expired before a seizure is accomplished or injunctive relief is obtained. FDA also has the statutory authority under section 516 of the act (21 U.S.C. 360f) to ban devices that present substantial deception, or unreasonable and substantial risk of illness or injury, or unreasonable, direct, and substantial E:\FR\FM\07JNN1.SGM 07JNN1 32988 Federal Register / Vol. 71, No. 109 / Wednesday, June 7, 2006 / Notices danger to the health of individuals. The final regulation for Banned Devices (44 FR 29221), which issued on May 18, 1979 (part 895 (21 CFR part 895)), contained certain reporting requirements (§§ 895.21(d) and 895.22(a)). FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section 800.55(g) 895.21(d) and 895.22(a) Total 1There Annual Frequency per Response No. of Respondents 1 26 Total Annual Responses 1 1 Hours per Response 1 26 Total Hours 25 16 25 416 441 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 No. of Recordkeepers Annual Frequency per Recordkeeper Total Annual Records Hours per Record 1 21 CFR Section 1 1 20 800.55(k) 1There Dated: June 1, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–8838 Filed 6–6–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D–0190] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Olfactory Test Device; Availability AGENCY: Food and Drug Administration, HHS. rwilkins on PROD1PC63 with NOTICES 20 are no capital costs or operating and maintenance costs associated with this collection of information. FDA’s estimate of the burden under the administrative detention provision is based on FDA’s discussion with the last firm whose devices had been detained. Historically, FDA has had very few or no annual responses for this information collection. ACTION: Total Hours Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Class II Special Controls Guidance Document: Olfactory Test Device.’’ This guidance document describes a means by which the olfactory test device may comply with the requirement of special controls for class II devices. It includes recommendations for validation of device performance and labeling. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify these device types into class II (special controls). VerDate Aug<31>2005 17:54 Jun 06, 2006 Jkt 208001 Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled ‘‘Class II Special Controls Guidance Document: Olfactory Test Device’’ to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ–220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301–443– 8818. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Eric A. Mann, Center for Devices and Radiological Health (HFZ–460), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301–594–2080. SUPPLEMENTARY INFORMATION: DATES: I. Background Elsewhere in this issue of the Federal Register, FDA is publishing a final rule classifying olfactory test device into class II (special controls) under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 360c(f)(2)). This guidance document will serve as the special control for olfactory test device. Section 513(f)(2) of the act provides that any person who submits a premarket notification under section 510(k) of the act (21 U.S.C. 360(k)) for a device that has not previously been classified may, within 30 days after receiving an order classifying the device in class III under section 513(f)(1) of the act, request FDA to classify the device under the criteria set forth in section 513(a)(1) of the act. FDA shall, within 60 days of receiving such a request, classify the device by written order. This classification shall be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the Federal Register announcing such classification. Because of the timeframes established by section 513(f)(2) of the act, FDA has determined, under § 10.115(g)(2) (21 CFR 10.115(g)(2)), that it is not feasible to allow for public participation before issuing this guidance as a final guidance document. Therefore, FDA is issuing this guidance document as a level 1 guidance document that is immediately in effect. FDA will consider any comments that are received in response to this notice to determine whether to amend the guidance document. II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (§ 10.115). The guidance represents the agency’s current thinking on olfactory test devices. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An E:\FR\FM\07JNN1.SGM 07JNN1

Agencies

[Federal Register Volume 71, Number 109 (Wednesday, June 7, 2006)]
[Notices]
[Pages 32987-32988]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-8838]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0220]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Administrative Detention and Banned Medical Devices

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 information collection 
requirements for Administrative Detention and Banned Medical Devices.

DATES: Submit written or electronic comments on the collection of 
information by August 7, 2006.

ADDRESSES: Submit electronic comments on the collection of information 
to: https://www.fda.gov/dockets/ecomments. 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: Denver Presley, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1472.

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.

Administrative Detention and Banned Medical Devices--(OMB Control 
Number 0910-0114)--Extension

    The Food and Drug Administration (FDA) has the statutory authority 
under section 304(g) of the Federal Food, Drug and Cosmetic Act (the 
act) (21 U.S.C. 334(g)), where officers or employees duly designated by 
the Secretary (FDA investigators) may detain devices during 
establishment inspections which are believed to be adulterated or 
misbranded. On March 9, 1979, FDA issued, under Sec.  800.55 (21 CFR 
800.55), a final regulation on Administrative Detention Procedures (44 
FR 13234), under section 304(g) of the act, which includes certain 
reporting requirements (Sec.  800.55(g)(1) and (g)(2)) and 
recordkeeping requirements (Sec.  800.55(k)). Under Sec.  800.55(g), an 
appellant of a detention order must show documentation of ownership if 
devices are detained at a place other than that of the appellant. Under 
Sec.  800.55(k), the owner or other responsible person must supply 
records about how the devices may have become adulterated or 
misbranded, as well as records of distribution of the detained devices. 
These recordkeeping requirements for administrative detentions allow 
FDA to trace devices for which the detention period expired before a 
seizure is accomplished or injunctive relief is obtained.
    FDA also has the statutory authority under section 516 of the act 
(21 U.S.C. 360f) to ban devices that present substantial deception, or 
unreasonable and substantial risk of illness or injury, or 
unreasonable, direct, and substantial

[[Page 32988]]

danger to the health of individuals. The final regulation for Banned 
Devices (44 FR 29221), which issued on May 18, 1979 (part 895 (21 CFR 
part 895)), contained certain reporting requirements (Sec. Sec.  
895.21(d) and 895.22(a)).
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     Annual Frequency per      Total Annual
                21 CFR Section                  No. of Respondents         Response              Responses        Hours per Response      Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
800.55(g)                                                         1                     1                     1                    25                 25
895.21(d) and 895.22(a)                                          26                     1                    26                    16                416
Total                                          ....................  ....................  ....................  ....................                441
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Annual Frequency per
                 21 CFR Section                   No. of Recordkeepers      Recordkeeper      Total Annual Records   Hours per Record     Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
800.55(k)                                                            1                     1                     1                 20                 20
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA's estimate of the burden under the administrative detention 
provision is based on FDA's discussion with the last firm whose devices 
had been detained. Historically, FDA has had very few or no annual 
responses for this information collection.

    Dated: June 1, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-8838 Filed 6-6-06; 8:45 am]
BILLING CODE 4160-01-S

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