Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing; Forms FDA 3486 and 3486A, 72893-72894 [2013-28990]

Download as PDF Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Notices Mr. Sheehy has entered into a Voluntary Settlement Agreement and has voluntarily agreed for a period of three (3) years, beginning on November 8, 2013: (1) To have his research supervised; Respondent agreed that prior to the submission of an application for U.S. Public Health Service (PHS) support for a research project on which the Respondent’s participation is proposed and prior to Respondent’s participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of his duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of Respondent’s research contribution; Respondent agreed that he shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed-upon supervision plan; (2) that any institution employing him shall submit, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHSsupported research in which Respondent is involved, a certification to ORI that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract; (3) to exclude himself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant; and (4) that a letter will be submitted to the editors of CEBP requesting that the journal retract the publication. David E. Wright, Director, Office of Research Integrity. [FR Doc. 2013–28887 Filed 12–3–13; 8:45 am] EMCDONALD on DSK67QTVN1PROD with NOTICES BILLING CODE 4150–31–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0579] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and TissueBased Product Deviations in Manufacturing; Forms FDA 3486 and 3486A 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. 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 0910–0458. Also include the FDA docket number found in brackets in the heading of this document. SUMMARY: 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: Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing; Forms FDA 3486 and 3486A—(OMB Control Number 0910– 0458)—Extension Under section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262), all biological products, including human blood and blood components, offered for sale in interstate commerce must be licensed and meet standards, VerDate Mar<15>2010 17:09 Dec 03, 2013 Jkt 232001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 72893 including those prescribed in the FDA regulations designed to ensure the continued safety, purity, and potency of such products. In addition, under section 361 of the PHS Act (42 U.S.C. 264), FDA may issue and enforce regulations necessary to prevent the introduction, transmission, or spread of communicable diseases between the States or possessions or from foreign countries into the States or possessions. Further, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 351) provides that drugs and devices (including human blood and blood components) are adulterated if they do not conform with current good manufacturing practice (CGMP) assuring that they meet the requirements of the FD&C Act. Establishments manufacturing biological products, including human blood and blood components, must comply with the applicable CGMP regulations (parts 211, 606, and 820 (21 CFR parts 211, 606, and 820)) and current good tissue practice (CGTP) regulations (part 1271 (21 CFR part 1271)) as appropriate. FDA regards biological product deviation (BPD) reporting and human cells, tissues and cellular and tissue-based products (HCT/P) deviation reporting to be an essential tool in its directive to protect public health by establishing and maintaining surveillance programs that provide timely and useful information. Section 600.14 (21 CFR 600.14), in brief, requires the manufacturer who holds the biological product license for other than human blood and blood components, and who had control over a distributed product when the deviation occurred, to report to the Center for Biologics Evaluation and Research (CBER) or to the Center for Drugs Evaluation and Research (CDER) as soon as possible, but at a date not to exceed 45 calendar days after acquiring information reasonably suggesting that a reportable event has occurred. Section 606.171, in brief, requires licensed manufacturers of human blood and blood components, including Source Plasma, unlicensed registered blood establishments, and transfusion services, who had control over a distributed product when the deviation occurred, to report to CBER as soon as possible but at a date not to exceed 45 calendar days after acquiring information reasonably suggesting that a reportable event has occurred. Similarly, § 1271.350(b), in brief, requires HCT/P establishments that manufacture non-reproductive HCT/Ps described in § 1271.10 to investigate and report to CBER all HCT/P deviations E:\FR\FM\04DEN1.SGM 04DEN1 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

Agencies

[Federal Register Volume 78, Number 233 (Wednesday, December 4, 2013)]
[Notices]
[Pages 72893-72894]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28990]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0579]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Biological Products:
Reporting of Biological Product Deviations and Human Cells, Tissues,
and Cellular and Tissue-Based Product Deviations in Manufacturing;
Forms FDA 3486 and 3486A

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 0910-0458.
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.

Biological Products: Reporting of Biological Product Deviations and
Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations
in Manufacturing; Forms FDA 3486 and 3486A--(OMB Control Number 0910-
0458)--Extension

Under section 351 of the Public Health Service Act (PHS Act) (42
U.S.C. 262), all biological products, including human blood and blood
components, offered for sale in interstate commerce must be licensed
and meet standards, including those prescribed in the FDA regulations
designed to ensure the continued safety, purity, and potency of such
products. In addition, under section 361 of the PHS Act (42 U.S.C.
264), FDA may issue and enforce regulations necessary to prevent the
introduction, transmission, or spread of communicable diseases between
the States or possessions or from foreign countries into the States or
possessions. Further, the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 351) provides that drugs and devices (including
human blood and blood components) are adulterated if they do not
conform with current good manufacturing practice (CGMP) assuring that
they meet the requirements of the FD&C Act. Establishments
manufacturing biological products, including human blood and blood
components, must comply with the applicable CGMP regulations (parts
211, 606, and 820 (21 CFR parts 211, 606, and 820)) and current good
tissue practice (CGTP) regulations (part 1271 (21 CFR part 1271)) as
appropriate. FDA regards biological product deviation (BPD) reporting
and human cells, tissues and cellular and tissue-based products (HCT/P)
deviation reporting to be an essential tool in its directive to protect
public health by establishing and maintaining surveillance programs
that provide timely and useful information.
Section 600.14 (21 CFR 600.14), in brief, requires the manufacturer
who holds the biological product license for other than human blood and
blood components, and who had control over a distributed product when
the deviation occurred, to report to the Center for Biologics
Evaluation and Research (CBER) or to the Center for Drugs Evaluation
and Research (CDER) as soon as possible, but at a date not to exceed 45
calendar days after acquiring information reasonably suggesting that a
reportable event has occurred. Section 606.171, in brief, requires
licensed manufacturers of human blood and blood components, including
Source Plasma, unlicensed registered blood establishments, and
transfusion services, who had control over a distributed product when
the deviation occurred, to report to CBER as soon as possible but at a
date not to exceed 45 calendar days after acquiring information
reasonably suggesting that a reportable event has occurred. Similarly,
Sec. 1271.350(b), in brief, requires HCT/P establishments that
manufacture non-reproductive HCT/Ps described in Sec. 1271.10 to
investigate and report to CBER all HCT/P deviations

[[Page 72894]]

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 non-reproductive HCT/Ps regulated solely under section 361
of the PHS Act as described in Sec. 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 Sec. 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 Sec. 606.171. CBER estimates that 5 percent of the total BPD
reports submitted to CBER under Sec. 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Section Form FDA No. Number of responses per Total annual burden per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
600.14................................................... 3486 91 7.71 702 2.0 1,404
606.171.................................................. 3486 1,679 32.73 54,947 2.0 109,894
1271.350(b).............................................. 3486 94 2.66 250 2.0 500
1271.350(b).............................................. \2\ 3486A 84 32.70 2,747 0.25 687
----------------------------------------------------------------------------------------------
Total................................................ 112,485
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Five percent of the number of respondents (1,679 x 0.05 = 84) and total annual responses to CBER (54,947 x 0.05 = 2,747).

Dated: November 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-28990 Filed 12-3-13; 8:45 am]
BILLING CODE 4160-01-P

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