Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarket Surveillance, 55723-55724 [2013-22013]

Download as PDF 55723 Federal Register / Vol. 78, No. 176 / Wednesday, September 11, 2013 / Notices LeRoy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Center for Disease Control and Prevention. [FR Doc. 2013–22038 Filed 9–10–13; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0557] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarket Surveillance AGENCY: 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. SUMMARY: Fax written comments on the collection of information by October 11, 2013. 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 0910–0449. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@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. DATES: Postmarket Surveillance—21 CFR Part 822 (OMB Control Number 0910– 0449)—Extension Section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360l) authorizes FDA to require a manufacturer to conduct postmarket surveillance (PS) of any device that meets the criteria set forth in the statute. The PS regulation establishes procedures that FDA uses to approve and disapprove PS plans. The regulation provides instructions to manufacturers so they know what information is required in a PS plan submission. FDA reviews PS plan submissions in accordance with part 822 (21 CFR part 822) in §§ 822.15 through 822.19 of the regulation, which describe the grounds for approving or disapproving a PS plan. In addition, the PS regulation provides instructions to manufacturers to submit interim and final reports in accordance with § 822.38. Respondents to this collection of information are those manufacturers who require postmarket surveillance of their products. In the Federal Register of May 16, 2013 (78 FR 28853), 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 respondents Activity/21 CFR section Number of responses per respondent Average burden per response Total annual responses Total hours Postmarket surveillance submission (§§ 822.9 and 822.10) Changes to PS plan after approval (§ 822.21) .................... Changes to PS plan for a device that is no longer marketed (§ 822.28) ................................................................ Waiver (§ 822.29) ................................................................. Exemption request (§ 822.30) .............................................. Periodic reports (§ 822.38) ................................................... 131 15 1 1 131 15 120 40 15,720 600 80 1 16 131 1 1 1 3 80 1 16 393 8 40 40 40 640 40 640 15,720 Total .............................................................................. ........................ ........................ ........................ ........................ 33,360 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Explanation of Reporting Burden Estimate. The burden captured in table 1 of this document is based on the data available in FDA’s internal tracking system. Sections 822.26, 822.27, and 822.34 do not constitute information collection subject to review under the PRA because ‘‘it entails no burden other than that necessary to identify the respondent, the date, the respondent’s address, and the nature of the instrument.’’ (See 5 CFR 1320.3(h)(1).) TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers Number of records per recordkeeper Manufacturer records (§ 822.31) ............................... Investigator records (§ 822.32) .................................. 131 393 1 1 131 393 20 5 2,620 1,965 Total .................................................................... .......................... ........................... ........................ ............................ 4,585 emcdonald on DSK67QTVN1PROD with NOTICES Activity/21 CFR section 1 There Total annual records Average burden per recordkeeping are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Mar<15>2010 16:50 Sep 10, 2013 Jkt 229001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\11SEN1.SGM 11SEN1 Total hours 55724 Federal Register / Vol. 78, No. 176 / Wednesday, September 11, 2013 / Notices Explanation of Recordkeeping Burden Estimate. FDA expects that at least some of the manufacturers will be able to satisfy the PS requirement using information or data they already have. For purposes of calculating burden, however, FDA has assumed that each PS order can only be satisfied by a 3-year clinically based surveillance plan, using three investigators. These estimates are based on FDA’s knowledge and experience with postmarket surveillance. Dated: September 5, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–22013 Filed 9–10–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013-N–1089] Agency Information Collection Activities; Proposed Collection; Comment Request; Recommended Glossary and Educational Outreach To Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use 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 the reporting requirements for the collection ‘‘Recommended Glossary and Educational Outreach to Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use.’’ DATES: Submit either electronic or written comments on the collection of information by November 12, 2013. 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 emcdonald on DSK67QTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:50 Sep 10, 2013 Jkt 229001 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: FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@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. Recommended Glossary and Educational Outreach to Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use—(OMB Control Number 0910–0553)—Extension Section 502 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 352), among other things, establishes requirements for the label or labeling of a medical device so that it is not misbranded. Section 351 of the Public Health Service Act (the PHS Act) PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 (42 U.S.C. 262) establishes requirements that manufacturers of biological products must submit a license application for FDA review and approval prior to marketing a biological product for introduction into interstate commerce. In the Federal Register of November 30, 2004 (69 FR 69606), FDA published a notice of availability of the guidance entitled ‘‘Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use.’’ The guidance document provides guidance for the voluntary use of selected symbols in place of text in labeling. It provides the labeling guidance required for: (1) In vitro diagnostic devices (IVDs), intended for professional use under 21 CFR 809.10, FDA’s labeling requirements for IVDs; and (2) FDA’s labeling requirements for biologics, including IVDs under 21 CFR parts 610 and 660. Under section 502(c) of the FD&C Act, a drug or device is misbranded, ‘‘. . . If any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.’’ The guidance document recommends that a glossary of terms accompany each IVD to define the symbols used on that device’s labels and/or labeling. Furthermore, the guidance recommends an educational outreach effort to enhance the understanding of newly introduced symbols. Both the glossary and educational outreach information help to ensure that IVD users have enough general familiarity with the symbols used, as well as provide a quick reference for available materials, thereby further ensuring that such labeling satisfies the labeling requirements under section 502(c) of the FD&C Act and section 351 of the PHS Act. The likely respondents for this collection of information are IVD manufacturers who plan to use the selected symbols in place of text on the labels and/or labeling of their IVDs. The glossary activity is inclusive of both domestic and foreign IVD manufacturers. FDA receives submissions from approximately 689 IVD manufacturers annually. The 4-hour estimate for a glossary is based on the average time necessary for a manufacturer to modify the glossary for the specific symbols used in labels or labeling for the IVDs manufactured. E:\FR\FM\11SEN1.SGM 11SEN1

Agencies

[Federal Register Volume 78, Number 176 (Wednesday, September 11, 2013)]
[Notices]
[Pages 55723-55724]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22013]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0557]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Postmarket 
Surveillance

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 October 
11, 2013.

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 0910-0449. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@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.

Postmarket Surveillance--21 CFR Part 822 (OMB Control Number 0910-
0449)--Extension

    Section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360l) authorizes FDA to require a manufacturer to conduct postmarket 
surveillance (PS) of any device that meets the criteria set forth in 
the statute. The PS regulation establishes procedures that FDA uses to 
approve and disapprove PS plans. The regulation provides instructions 
to manufacturers so they know what information is required in a PS plan 
submission. FDA reviews PS plan submissions in accordance with part 822 
(21 CFR part 822) in Sec. Sec.  822.15 through 822.19 of the 
regulation, which describe the grounds for approving or disapproving a 
PS plan. In addition, the PS regulation provides instructions to 
manufacturers to submit interim and final reports in accordance with 
Sec.  822.38. Respondents to this collection of information are those 
manufacturers who require postmarket surveillance of their products.
    In the Federal Register of May 16, 2013 (78 FR 28853), 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                        Average
     Activity/21 CFR section         Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Postmarket surveillance                      131               1             131             120          15,720
 submission (Sec.  Sec.   822.9
 and 822.10)....................
Changes to PS plan after                      15               1              15              40             600
 approval (Sec.   822.21).......
Changes to PS plan for a device               80               1              80               8             640
 that is no longer marketed
 (Sec.   822.28)................
Waiver (Sec.   822.29)..........               1               1               1              40              40
Exemption request (Sec.                       16               1              16              40             640
 822.30)........................
Periodic reports (Sec.   822.38)             131               3             393              40          15,720
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          33,360
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Explanation of Reporting Burden Estimate. The burden captured in 
table 1 of this document is based on the data available in FDA's 
internal tracking system. Sections 822.26, 822.27, and 822.34 do not 
constitute information collection subject to review under the PRA 
because ``it entails no burden other than that necessary to identify 
the respondent, the date, the respondent's address, and the nature of 
the instrument.'' (See 5 CFR 1320.3(h)(1).)

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
     Activity/21 CFR section         Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Manufacturer records (Sec.                   131               1             131              20           2,620
 822.31)........................
Investigator records (Sec.                   393               1             393               5           1,965
 822.32)........................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           4,585
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 55724]]

    Explanation of Recordkeeping Burden Estimate. FDA expects that at 
least some of the manufacturers will be able to satisfy the PS 
requirement using information or data they already have. For purposes 
of calculating burden, however, FDA has assumed that each PS order can 
only be satisfied by a 3-year clinically based surveillance plan, using 
three investigators. These estimates are based on FDA's knowledge and 
experience with postmarket surveillance.

    Dated: September 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22013 Filed 9-10-13; 8:45 am]
BILLING CODE 4160-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.