81 FR 79504 - 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 Deviations in Manufacturing
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 219 (November 14, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 219 (November 14, 2016)
| Page Range | 79504-79506 | |
| FR Document | 2016-27259 |
[Federal Register Volume 81, Number 219 (Monday, November 14, 2016)] [Notices] [Pages 79504-79506] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-27259] ----------------------------------------------------------------------- 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 Deviations in Manufacturing AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) 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 (the PRA). DATES: Fax written comments on the collection of information by December 14, 2016. 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 [email protected]. 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, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]. 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 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, section 501 of 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 (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 product (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 [[Page 79505]] reportable event has occurred. Section 606.171 (21 CFR 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) (21 CFR 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 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. 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 2015. 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 has 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, Form FDA 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 Form FDA 3486A. CBER further estimates that it would take between 10 to 20 minutes to complete Form FDA 3486A. 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 parts 211 (approved under OMB control number 0910-0139), 606 (approved under OMB control number 0910-0116), 820 (approved under OMB control number 0910-0073) and 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 7, 2016 (81 FR 36550), we published a 60-day notice requesting public comment on the proposed extension of this collection of information. One comment was submitted in response to the notice concerning potential ways to minimize the burden associated with the information collection. The commenter encouraged FDA to permit the use of attachments to Forms FDA 3486 and 3486A when reporting multiple biological product deviations from a single starting source rather than retype the information. The comment suggested, alternatively, that respondents' burden might be reduced by ``capping the forms at a much lower number of products/lots than the current maximum of 100.'' Finally, the comment suggested Forms FDA 3486 and 3486A incorporate technology that would permit barcode scanning for relevant fields. FDA is appreciative of this feedback. At this time, however, we are unable to make the suggested revisions to the information collection. Currently, product information can readily be imported from a Microsoft Excel file (in XLS format) into the eBPD report without having to be retyped (up to 100 units/lots). In addition, the product information entered on Form FDA 3486 automatically populates Form FDA 3486A minimizing the need to manually reenter required information. While we will consider future enhancements that allow for attachments and integrate barcode or other technologies that facilitate or otherwise improve reporting, we must ensure that upgrades are compatible with our existing system. FDA estimates the burden of this collection of information as follows: Table 1--Estimate Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR section; activity FDA Form No. Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- 600.14; Reporting of BPDs by 3486 102 5.99 611 2................................. 1,222 licensed manufacturers. 606.171; Reporting of product 3486 1,738 26.34 45,774 2................................. 91,548 deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services. 1271.350(b); HCT/P deviations....... 3486 97 2.64 256 2................................. 512 Web-based Addendum.................. \2\ 3486A 87 26.31 2,289 0.25 (15 minutes)................. 572 ---------------------------------------------------------------- --------------- Total........................... .............. .............. .............. .............. .................................. 93,854 -------------------------------------------------------------------------------------------------------------------------------------------------------- \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 (1,738 x 0.05 = 87) and total annual responses to CBER (45,774 x 0.05 = 2,289). [[Page 79506]] Dated: November 7, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-27259 Filed 11-10-16; 8:45 am] BILLING CODE 4164-01-P
![79504 Federal Register / Vol. 81, No. 219 / Monday, November 14, 2016 / Notices
Agency may not conduct or sponsor, consideration of the burden of user fee SUPPLEMENTARY INFORMATION: In
and a person is not required to respond amounts on small businesses in the compliance with 44 U.S.C. 3507, FDA
to, a collection of information unless it Federal Register of June 5, 2015 (80 FR has submitted the following proposed
displays a currently valid OMB control 32136), which also announced the draft collection of information to OMB for
number. FDA is issuing this final guidance for industry on VQIP. We are review and clearance.
guidance subject to OMB approval of considering comments we received on Biological Products: Reporting of
the collection of information. Before the the VQIP user fee. We will publish the Biological Product Deviations and
Agency begins collecting information actual fee in a Federal Register notice Human Cells, Tissues, and Cellular and
for the VQIP program, FDA will publish in accordance with section 743(b)(1) of Tissue-Based Product Deviations in
a notice in the Federal Register the FD&C Act prior to the fiscal year Manufacturing; Forms FDA 3486 and
announcing OMB’s decision to approve, when we begin program benefits. 3486A.
modify, or disapprove the information Dated: November 7, 2016. OMB Control Number 0910–0458—
collection provisions in the guidance. Extension
The guidance also refers to previously Leslie Kux,
approved collections of information Associate Commissioner for Policy. Under section 351 of the Public
found in FDA regulations. The [FR Doc. 2016–27252 Filed 11–10–16; 8:45 am] Health Service Act (PHS Act) (42 U.S.C.
collections of information regarding BILLING CODE 4164–01–P 262), all biological products, including
food labeling have been approved under human blood and blood components,
OMB control number 0910–0381; the offered for sale in interstate commerce
collections of information regarding DEPARTMENT OF HEALTH AND must be licensed and meet standards,
Low Acid Canned Food have been HUMAN SERVICES including those prescribed in FDA
approved under OMB control number regulations, designed to ensure the
0910–0037; the collections of Food and Drug Administration continued safety, purity, and potency of
information regarding Third-Party such products. In addition under
[Docket No. FDA–2013–N–0579]
Certification Bodies to Conduct Food section 361 of the PHS Act (42 U.S.C.
Safety Audits and to Issue Certifications Agency Information Collection 264), FDA may issue and enforce
have been approved under OMB control Activities; Submission for Office of regulations necessary to prevent the
number 0910–0750; the collections of Management and Budget Review; introduction, transmission, or spread of
information regarding Current Good Comment Request; Biological communicable diseases between the
Manufacturing Practice and Hazard Products: Reporting of Biological States or possessions or from foreign
Analysis and Risk-Based Preventive Product Deviations and Human Cells, countries into the States or possessions.
Controls for Human Food have been Tissues, and Cellular and Tissue- Further, section 501 of the Federal
approved under OMB control number Based Deviations in Manufacturing Food, Drug, and Cosmetic Act (the
0910–0751; the collections of FD&C Act) (21 U.S.C. 351) provides that
information regarding Current Good AGENCY: Food and Drug Administration, drugs and devices (including human
Manufacturing Practice and Hazard HHS. blood and blood components) are
Analysis and Risk-Based Preventive ACTION: Notice. adulterated if they do not conform with
Controls for Food for Animals have been current good manufacturing practice
approved under OMB control number SUMMARY: The Food and Drug (CGMP) assuring that they meet the
0910–0789; the collections of Administration (FDA or we) is requirements of the FD&C Act.
information regarding the Foreign announcing that a proposed collection Establishments manufacturing
Supplier Verification Program have of information has been submitted to the biological products, including human
been approved under OMB control Office of Management and Budget blood and blood components, must
number 0910–0752; the collections of (OMB) for review and clearance under comply with the applicable CGMP
information regarding the Sanitary the Paperwork Reduction Act of 1995 regulations (21 CFR parts 211, 606, and
Transportation of Human and Animal (the PRA). 820)) and current good tissue practice
Food have been approved under OMB DATES: Fax written comments on the (CGTP) regulations (part 1271 (21 CFR
control number 0910–0773; and the collection of information by December part 1271)) as appropriate. FDA regards
collections of information regarding 14, 2016. biological product deviation (BPD)
Focused Mitigation Strategies to Protect reporting and human cells, tissues, and
ADDRESSES: To ensure that comments on
Food Against Intentional Adulteration cellular and tissue-based product (HCT/
the information collection are received,
have been approved under OMB control P) deviation reporting to be an essential
OMB recommends that written
number 0910–0812. tool in its directive to protect public
comments be faxed to the Office of
health by establishing and maintaining
III. Electronic Access Information and Regulatory Affairs,
surveillance programs that provide
OMB, Attn: FDA Desk Officer, FAX:
Persons with access to the Internet timely and useful information.
202–395–7285, or emailed to oira_ Section 600.14 (21 CFR 600.14), in
may obtain the guidance at either http:// submission@omb.eop.gov. All
www.fda.gov/RegulatoryInformation/ brief, requires the manufacturer who
comments should be identified with the holds the biological product license, for
Guidances or http:// OMB control number 0910–0458. Also
www.regulations.gov. Use the FDA Web other than human blood and blood
include the FDA docket number found components, and who had control over
site listed in the previous sentence to in brackets in the heading of this a distributed product when the
mstockstill on DSK3G9T082PROD with NOTICES
find the most current version of the document.
guidance. deviation occurred, to report to the
FOR FURTHER INFORMATION CONTACT: FDA Center for Biologics Evaluation and
IV. Other Issues for Consideration PRA Staff, Office of Operations, Food Research (CBER) or to the Center for
FSMA directs FDA to collect user fees and Drug Administration, Three White Drugs Evaluation and Research (CDER)
to fund VQIP. Consistent with section Flint North, 10A63, 11601 Landsdown as soon as possible but at a date not to
743(b)(2)(B)(iii) of the FD&C Act, we set St., North Bethesda, MD 20852, exceed 45 calendar days after acquiring
forth a proposed set of guidelines in PRAStaff@fda.hhs.gov. information reasonably suggesting that a
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![79506 Federal Register / Vol. 81, No. 219 / Monday, November 14, 2016 / Notices
Dated: November 7, 2016. Information Collection Request Title: hospitals achieving any recognition
Leslie Kux, National Hospital Organ Donation level.
Associate Commissioner for Policy. Campaign Activity Scorecard OMB No. A list of recognized hospitals is
[FR Doc. 2016–27259 Filed 11–10–16; 8:45 am] 0915–0373, Revision shared with all campaign participants
BILLING CODE 4164–01–P
Abstract: HRSA’s Hospital Campaign, during monthly webinars, in campaign
a special initiative of the Workplace e-newsletters, and in communication
Partnership for Life program, enlists the pieces sent out by the campaign’s
DEPARTMENT OF HEALTH AND help of hospitals nationwide to increase national partners, which include the
HUMAN SERVICES the number of registered organ, eye, and American Hospital Association and the
tissue donors by hosting education and American Society of Transplantation. In
Health Resources and Services registry events in their hospitals and addition, local donation organizations
Administration communities. The Activity Scorecard and participating state hospital
provides activity ideas to participating associations use the results to pay
Agency Information Collection hospitals and assigns points to each tribute to HRSA-recognized hospitals in
Activities: Proposed Collection: Public activity. Hospitals that earn a certain their local service areas. The
Comment Request; National Hospital number of points annually are information collected also helps HRSA
Organ Donation Campaign Activity recognized by HRSA and the campaign’s identify best practices that are then
AGENCY: Health Resources and Services national partners. shared with all hospital partners on the
Need and Proposed Use of the
Administration (HRSA), Department of monthly webinars. This version of the
Information: There is a substantial
Health and Human Services. scorecard contains two new
imbalance in the U.S. between the
ACTION: Notice. opportunities for hospitals to earn
number of people whose life depends
points: A point is awarded for each
SUMMARY: In compliance with the on an organ transplant (currently about
donor registration a hospital motivates
requirement for opportunity for public 120,000) and the annual number of
and points are awarded for reaching the
comment on proposed data collection organ donors (approximately 14,000
hospital’s donor registration goal.
projects (Section 3506(c)(2)(A) of the living and deceased donors). In
response to the need for increased Likely Respondents: Hospital
Paperwork Reduction Act of 1995), development and public relations staff
HRSA announces plans to submit an donation, HRSA conducts public
outreach initiatives to encourage the of organ procurement and other
Information Collection Request (ICR), donation organizations, hospital staff
described below, to the Office of American public to enroll in their state
donor registry as future organ donors. such as nurses or public relations/
Management and Budget (OMB). Prior communications professionals, and
to submitting the ICR to OMB, HRSA As part of this initiative, HRSA supports
this National Hospital Organ Donation volunteers that work with the hospitals
seeks comments from the public on organ donation initiatives.
regarding the burden estimate, below, or Campaign to involve hospitals
any other aspect of the ICR. throughout the nation as partners in the Burden Statement: Burden in this
national effort to educate their staff and context means the time expended by
DATES: Comments on this ICR must be
communities about the urgent need for persons to generate, maintain, retain,
received no later than January 13, 2017. disclose, or provide the information
donors and encourage donor registry
ADDRESSES: Submit your comments to requested. This includes the time
enrollments.
paperwork@hrsa.gov or mail the HRSA The activity scorecard serves two key needed to review instructions; to
Information Collection Clearance campaign functions: (1) It motivates and develop, acquire, install, and utilize
Officer, Room 14N–39, 5600 Fishers facilitates hospitals’ participation in this technology and systems for the purpose
Lane, Rockville, MD 20857. campaign, and (2) it provides the basis of collecting, validating, and verifying
FOR FURTHER INFORMATION CONTACT: To for rewarding hospitals for their information, processing and
request more information on the accomplishments. In providing more maintaining information, and disclosing
proposed project or to obtain a copy of than 40 actionable donation promotion and providing information; to train
the data collection plans and draft strategies hospitals can choose to personnel and to be able to respond to
instruments, email paperwork@hrsa.gov implement, it eases the process of a collection of information; to search
or call the HRSA Information Collection planning and participation for hospital data sources; to complete and review
Clearance Officer at (301) 443–1984. teams. In addition, by attaching point the collection of information; and to
SUPPLEMENTARY INFORMATION: When levels to each activity, HRSA uses the transmit or otherwise disclose the
submitting comments or requesting information collected to recognize information. The total annual burden
information, please include the hospital achievements at bronze, silver, hours estimated for this Information
information request collection title for gold, and platinum point equivalents Collection Request are summarized in
reference. and provides certificates for all the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of Total burden per Total burden
Form name responses per
respondents responses response hours
respondent (in hours)
mstockstill on DSK3G9T082PROD with NOTICES
Activity Scorecard (electronic PDF) ..................................... 1,000 1 1,000 .125 125
Total .............................................................................. 1,000 ........................ 1,000 ........................ 125
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Document Created: 2018-10-24 10:46:15
Document Modified: 2018-10-24 10:46:15
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by December 14, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 79504 |
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