Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act, 72894-72895 [2013-29010]

Download as PDF 72894 Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Notices relating to a distributed HCT/P that relates to the core CGTP requirements, if the deviation occurred in the establishment’s facility or in a facility that performed a manufacturing step for the establishment under contract, agreement or other arrangement, and to report such HCT/P deviations within 45 days of the discovery of the event. Form FDA 3486 is used to submit BPD reports and HCT/P deviation reports. Respondents to this collection of information are (1) Licensed manufacturers of biological products other than human blood and blood components; (2) licensed manufacturers of blood and blood components including Source Plasma; (3) unlicensed registered blood establishments; (4) transfusion services; and (5) establishments that manufacture nonreproductive HCT/Ps regulated solely under section 361 of the PHS Act as described in § 1271.10. The number of respondents and total annual responses are based on the BPD reports and HCT/ P deviation reports FDA received in fiscal year 2012. The number of licensed manufacturers and total annual responses under § 600.14 include the estimates for BPD reports submitted to both CBER and CDER. Based on the information from industry, the estimated average time to complete a deviation report is 2 hours, which includes a minimal one-time burden to create a user account for those reports submitted electronically. The availability of the standardized report form, Form FDA 3486, and the ability to submit this report electronically to CBER (CDER does not currently accept electronic filings) further streamlines the report submission process. CBER developed a Web-based addendum to Form FDA 3486 (Form FDA 3486A) to provide additional information when a BPD report has been reviewed by FDA and evaluated as a possible recall. The additional information requested includes information not contained in the Form FDA 3486 such as: (1) Distribution pattern; (2) method of consignee notification; (3) consignee(s) of products for further manufacture; (4) additional product information; (5) updated product disposition; and (6) industry recall contacts. This information is requested by CBER through email notification to the submitter of the BPD report. This information is used by CBER for recall classification purposes. At this time, Addendum 3486A is being used only for those BPD reports submitted under § 606.171. CBER estimates that 5 percent of the total BPD reports submitted to CBER under § 606.171 would need additional information submitted in the addendum. CBER further estimates that it would take between 10 to 20 minutes to complete the addendum. For calculation purposes, CBER is using 15 minutes. Activities such as investigating, changing standard operating procedures or processes, and followup are currently required under 21 CFR part 211 (approved under OMB control number 0910–0139), part 606 (approved under OMB control number 0910–0116), part 820 (approved under OMB control number 0910–0073), and part 1271 (approved under OMB control number 0910–0543) and, therefore, are not included in the burden calculation for the separate requirement of submitting a deviation report to FDA. In the Federal Register of June 5, 2013 (78 FR 33846), 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 21 CFR Section Number of respondents Form FDA No. 600.14 ...................................................... 606.171 .................................................... 1271.350(b) .............................................. 1271.350(b) .............................................. 3486 3486 3486 2 3486A Number of responses per respondent 91 1,679 94 84 7.71 32.73 2.66 32.70 Total annual responses 702 54,947 250 2,747 Average burden per response 2.0 2.0 2.0 0.25 Total .................................................. Total hours 1,404 109,894 500 687 112,485 1 There 2 Five are no capital costs or operating and maintenance costs associated with this collection of information. percent of the number of respondents (1,679 × 0.05 = 84) and total annual responses to CBER (54,947 × 0.05 = 2,747). Dated: November 27, 2013. Leslie Kux, Assistant Commissioner for Policy. EMCDONALD on DSK67QTVN1PROD with NOTICES BILLING CODE 4160–01–P Food and Drug Administration [Docket No. FDA–2013–N–0795] [FR Doc. 2013–28990 Filed 12–3–13; 8:45 am] information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of SUMMARY: VerDate Mar<15>2010 17:09 Dec 03, 2013 Jkt 232001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 Fax written comments on the collection of information by January 3, 2014. 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 0910–0375. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: E:\FR\FM\04DEN1.SGM 04DEN1 Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Notices 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. FOR FURTHER INFORMATION CONTACT: Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act— (OMB Control Number 0910–0375)— Extension Section 210 of the Food and Drug Administration Modernization Act (FDAMA) established section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360m), directing FDA to accredit persons in the private sector to review certain premarket notifications (510(k)s). Participation in this thirdparty review program by accredited persons is entirely voluntary. A third party wishing to participate will submit a request for accreditation to FDA. Accredited third-party reviewers have the ability to review a manufacturer’s 510(k) submission for selected devices. After reviewing a submission, the reviewer will forward a copy of the 510(k) submission, along with the reviewer’s documented review and recommendation to FDA. Third-party reviewers should maintain records of their 510(k) reviews and a copy of the 510(k) for a reasonable period of time, usually a period of 3 years. 72895 This information collection will allow FDA to continue to implement the accredited person review program established by FDAMA and improve the efficiency of 510(k) review for low- to moderate-risk devices. Respondents to this information collection are businesses or other forprofit organizations. In the Federal Register of July 9, 2013 (78 FR 41065), FDA published a 60-day notice requesting public comment on the proposed collection of information to which one comment was received but was unrelated to the information collection. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN Number of responses per respondent Number of respondents Activity Requests for Accreditation ..................... 510(k) Reviews Conducted by Accredited Third Parties ................................ Total annual responses Average burden per response 1 1 1 24 24 10 26 260 40 10,400 Total ................................................ 1 There Total hours 10,424 are no capital costs or operating and maintenance costs associated with this collection of information. 510(k) Reviews Conducted by Accredited Third Parties According to FDA’s data, the number of 510(k)s submitted for third-party review is approximately 260 annually, which is 26 annual reviews per each of the 10 accredited reviewers. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN Activity Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours 510(k) reviews ........................................ 10 26 260 10 2,600 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Third-party reviewers are required to keep records of their review of each submission. According to FDA’s data, the Agency anticipates approximately 260 submissions of 510(k)s for thirdparty review per year. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: November 27, 2013. Leslie Kux, Assistant Commissioner for Policy. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Tissue Intended for Transplantation EMCDONALD on DSK67QTVN1PROD with NOTICES [FR Doc. 2013–29010 Filed 12–3–13; 8:45 am] BILLING CODE 4160–01–P Food and Drug Administration [Docket No. FDA–2013–N–0797] 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 SUMMARY: VerDate Mar<15>2010 17:09 Dec 03, 2013 Jkt 232001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by January 3, 2014. 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 0910–0302. Also include the FDA docket number found in brackets in the heading of this document. FDA PRA Staff, Office of Operations, Food FOR FURTHER INFORMATION CONTACT: E:\FR\FM\04DEN1.SGM 04DEN1

Agencies

[Federal Register Volume 78, Number 233 (Wednesday, December 4, 2013)]
[Notices]
[Pages 72894-72895]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-29010]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0795]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medical Devices; 
Third-Party Review Under the Food and Drug Administration Modernization 
Act

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 January 
3, 2014.

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 0910-0375. 
Also include the FDA docket number found in brackets in the heading of 
this document.

[[Page 72895]]


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.

Medical Devices; Third-Party Review Under the Food and Drug 
Administration Modernization Act--(OMB Control Number 0910-0375)--
Extension

    Section 210 of the Food and Drug Administration Modernization Act 
(FDAMA) established section 523 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360m), directing FDA to accredit persons in the private 
sector to review certain premarket notifications (510(k)s). 
Participation in this third-party review program by accredited persons 
is entirely voluntary. A third party wishing to participate will submit 
a request for accreditation to FDA. Accredited third-party reviewers 
have the ability to review a manufacturer's 510(k) submission for 
selected devices. After reviewing a submission, the reviewer will 
forward a copy of the 510(k) submission, along with the reviewer's 
documented review and recommendation to FDA. Third-party reviewers 
should maintain records of their 510(k) reviews and a copy of the 
510(k) for a reasonable period of time, usually a period of 3 years.
    This information collection will allow FDA to continue to implement 
the accredited person review program established by FDAMA and improve 
the efficiency of 510(k) review for low- to moderate-risk devices.
    Respondents to this information collection are businesses or other 
for-profit organizations.
    In the Federal Register of July 9, 2013 (78 FR 41065), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information to which one comment was received but was 
unrelated to the information collection.
    FDA estimates the burden of this collection of information as 
follows:

                                                       Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                  Number of
                         Activity                              Number of        responses per       Total annual      Average burden      Total hours
                                                              respondents         respondent         responses         per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Requests for Accreditation...............................                  1                  1                  1                 24                 24
510(k) Reviews Conducted by Accredited Third Parties.....                 10                 26                260                 40             10,400
                                                          ----------------------------------------------------------------------------------------------
    Total................................................  .................  .................  .................  .................             10,424
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

510(k) Reviews Conducted by Accredited Third Parties
    According to FDA's data, the number of 510(k)s submitted for third-
party review is approximately 260 annually, which is 26 annual reviews 
per each of the 10 accredited reviewers.

                                                     Table 2--Estimated Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Number of       Number of records     Total annual     Average burden per
                      Activity                           recordkeepers     per recordkeeper         records          recordkeeping        Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) reviews......................................                 10                  26                 260                  10               2,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Third-party reviewers are required to keep records of their review 
of each submission. According to FDA's data, the Agency anticipates 
approximately 260 submissions of 510(k)s for third-party review per 
year.

    Dated: November 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-29010 Filed 12-3-13; 8:45 am]
BILLING CODE 4160-01-P