83 FR 7745 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff-Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Principle
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 36 (February 22, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 36 (February 22, 2018)
| Page Range | 7745-7747 | |
| FR Document | 2018-03613 |
[Federal Register Volume 83, Number 36 (Thursday, February 22, 2018)] [Notices] [Pages 7745-7747] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03613] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0115] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff--Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Principle AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 collection of information concerning class II special controls for an automated blood cell separator device operating by centrifugal or filtration separation principle. DATES: Submit either electronic or written comments on the collection of information by April 23, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 23, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to [[Page 7746]] the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2012-N-0115 for ``Guidance for Industry and FDA Staff--Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]. 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. Guidance for Industry and FDA Staff--Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle, OMB Control Number 0910-0594--Extension Under the Safe Medical Devices Act of 1990 (Pub. L. 101-629), FDA may establish special controls, including performance standards, postmarket surveillance, patient registries, guidelines, and other appropriate actions it believes necessary to provide reasonable assurance of the safety and effectiveness of the device. The special control guidance serves as the special control for the automated blood cell separator device operating by centrifugal or filtration separation principle intended for the routine collection of blood and blood components (Sec. 864.9245 (21 CFR 864.9245)). For currently marketed products not approved under the premarket approval process, the manufacturer should file with FDA for 3 consecutive years an annual report on the anniversary date of the device reclassification from class III to class II or on the anniversary date of the 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360(k)) clearance. Any subsequent change to the device requiring the submission of a premarket notification in accordance with section 510(k) of the FD&C Act should be included in the annual report. Also, a manufacturer of a device determined to be substantially equivalent to the centrifugal or filtration-based automated cell separator device intended for the routine collection of blood and blood components should comply with the same general and special controls. The annual report should include, at a minimum, a summary of anticipated and unanticipated adverse events that have occurred and that are not required to be reported by manufacturers under Medical Device Reporting (MDR) (part [[Page 7747]] 803 (21 CFR part 803)). The reporting of adverse device events summarized in an annual report will alert FDA to trends or clusters of events that might be a safety issue otherwise unreported under the MDR regulation. The report should also include any subsequent change to the preamendments class III device requiring a 30-day notice in accordance with 21 CFR 814.39(f). Reclassification of this device from class III to class II relieves manufacturers of the burden of complying with the premarket approval requirements of section 515 of the FD&C Act (21 U.S.C. 360e) and may permit small potential competitors to enter the marketplace by reducing the burden. Although the special control guidance recommends that manufacturers of these devices file with FDA an annual report for 3 consecutive years, this would be less burdensome than the current postapproval requirements under 21 CFR part 814, subpart E, including the submission of periodic reports under 21 CFR 814.84. Collecting or transfusing facilities, the intended users of the device, and the device manufacturers have certain responsibilities under the Federal regulations. For example, collecting or transfusing facilities are required to maintain records of any reports of complaints of adverse reactions (21 CFR 606.170), while the device manufacturer is responsible for conducting an investigation of each event that is reasonably known to the manufacturer and evaluating the cause of the event (Sec. 803.50(b) (21 CFR 803.50(b)). In addition, manufacturers of medical devices are required to submit to FDA individual adverse event reports of death, serious injury, and malfunctions (Sec. 803.50). In the special control guidance document, FDA recommends that manufacturers include in their three annual reports a summary of adverse reactions maintained by the collecting or transfusing facility or similar reports of adverse events collected. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Reporting activity Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- Annual Report...................................................... 3 1 3 5 15 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Based on FDA records, there are approximately three manufacturers of automated blood cell separator devices. We estimate that the manufacturers will spend approximately 5 hours preparing and submitting the annual report. The total burden hours are reduced from previous collections due to a decrease in the number of manufacturers. Other burden hours required for Sec. 864.9245 are reported and approved under OMB control number 0910-0120 (premarket notification submission 510(k), 21 CFR part 807, subpart E), and OMB control number 0910-0437 (MDR, part 803). Dated: February 15, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-03613 Filed 2-21-18; 8:45 am] BILLING CODE 4164-01-P
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will discuss and make and between approximately 11:15 a.m. DEPARTMENT OF HEALTH AND
recommendations regarding the device to 12:15 p.m. on March 22, 2018. Those HUMAN SERVICES
reclassification from Class III to Class II individuals interested in making formal
of nucleic acid and serology-based oral presentations should notify the Food and Drug Administration
point-of-care and laboratory-based in contact person and submit a brief [Docket No. FDA–2012–N–0115]
vitro diagnostic devices indicated for statement of the general nature of the
use as aids in the diagnosis of human evidence or arguments they wish to Agency Information Collection
immunodeficiency virus (HIV) present, the names and addresses of Activities; Proposed Collection;
infection. In the afternoon session, the proposed participants, and an Comment Request; Guidance for
Committee will hear an overview of the indication of the approximate time Industry and Food and Drug
research presentations on the research requested to make their presentation on Administration Staff—Class II Special
programs of the Laboratory of Emerging or before March 6, 2018. Time allotted Controls Guidance Document:
Pathogens, the Laboratory of Bacterial for each presentation may be limited. If Automated Blood Cell Separator
and Transmissible Spongiform the number of registrants requesting to Device Operating by Centrifugal or
Encephalopathy Agents, and the speak is greater than can be reasonably Filtration Principle
Laboratory of Molecular Virology in the accommodated during the scheduled
Division of Emerging Transfusion- open public hearing session, FDA may AGENCY: Food and Drug Administration,
Transmitted Diseases, Office of Blood conduct a lottery to determine the HHS.
Research and Review Center for speakers for the scheduled open public ACTION: Notice.
Biologics Evaluation and Research. hearing session. The contact person will
After the open session, the meeting will notify interested persons regarding their SUMMARY: The Food and Drug
be closed to the public to permit request to speak by March 7, 2018. Administration (FDA or Agency) is
discussion where disclosure would announcing an opportunity for public
Persons attending FDA’s advisory comment on the proposed collection of
constitute an unwarranted invasion of
committee meetings are advised that the certain information by the Agency.
personal privacy in accordance with 5
Agency is not responsible for providing Under the Paperwork Reduction Act of
U.S.C 552b(c)(6).
On March 22, 2018, the Joint access to electrical outlets. 1995 (PRA), Federal Agencies are
Committee will discuss and make FDA welcomes the attendance of the required to publish notice in the
recommendations regarding the public at its advisory committee Federal Register concerning each
reclassification from Class III to Class II meetings and will make every effort to proposed collection of information,
of nucleic acid and serology-based in accommodate persons with disabilities. including each proposed extension of an
vitro diagnostic devices indicated for If you require accommodations due to a existing collection of information, and
use as aids in diagnosis of hepatitis C disability, please contact Bryan Emery to allow 60 days for public comment in
virus (HCV) infection and/or for use as at least 7 days in advance of the meeting response to the notice. This notice
aids in the management of HCV infected (See, FOR FURTHER INFORMATION solicits comments on the collection of
patients. CONTACT). information concerning class II special
All the devices that will be discussed Closed Committee Deliberations: On controls for an automated blood cell
by the Committee during the 2-day March 21, 2018, between 4:40 p.m. and separator device operating by
meeting are post-amendment devices 5:15 p.m., the meeting will be closed to centrifugal or filtration separation
that currently are classified into Class III permit discussion where disclosure principle.
under section 513(f)(1) of the Federal would constitute a clearly unwarranted
Food, Drug, and Cosmetic Act (21 U.S.C. DATES: Submit either electronic or
invasion of personal privacy (5 U.S.C. written comments on the collection of
360c(f)(1)).
552b(c)(6)). The recommendations of the information by April 23, 2018.
FDA intends to make background
advisory committee regarding the ADDRESSES: You may submit comments
material available to the public no later
than 2 business days before the meeting. progress of the investigator’s research as follows. Please note that late,
If FDA is unable to post the background will, along with other information, be untimely filed comments will not be
material on its website prior to the used in making decisions regarding pay considered. Electronic comments must
meeting, the background material will adjustments of service fellows or be submitted on or before April 23,
be made publicly available at the promotion of individual scientists who 2018. The https://www.regulations.gov
location of the advisory committee are permanent CBER staff. electronic filing system will accept
meeting, and the background material FDA is committed to the orderly comments until midnight Eastern Time
will be posted on FDA’s website after conduct of its advisory committee at the end of April 23, 2018. Comments
the meeting. Background material is meetings. Please visit our website at received by mail/hand delivery/courier
available at https://www.fda.gov/ https://www.fda.gov/ (for written/paper submissions) will be
AdvisoryCommittees/Calendar/ AdvisoryCommittees/ considered timely if they are
default.htm. Scroll down to the AboutAdvisoryCommittees/ postmarked or the delivery service
appropriate advisory committee meeting ucm111462.htm for procedures on acceptance receipt is on or before that
link. public conduct during advisory date.
Procedure: Interested persons may committee meetings.
present data, information, or views, Electronic Submissions
Notice of this meeting is given under
orally or in writing, on issues pending the Federal Advisory Committee Act (5 Submit electronic comments in the
daltland on DSKBBV9HB2PROD with NOTICES
before the committee. Written U.S.C. app.) following way:
submissions may be made to the contact • Federal eRulemaking Portal:
person on or before March 14, 2018. Dated: February 15, 2018. https://www.regulations.gov. Follow the
Oral presentations from the public will Leslie Kux, instructions for submitting comments.
be scheduled between approximately Associate Commissioner for Policy. Comments submitted electronically,
12:25 p.m. to 1:25 p.m. and from 4:25 [FR Doc. 2018–03614 Filed 2–21–18; 8:45 am] including attachments, to https://
p.m. to 4:40 p.m. on March 21, 2018, BILLING CODE 4164–01–P www.regulations.gov will be posted to
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![Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices 7747
803 (21 CFR part 803)). The reporting of recommends that manufacturers of these reasonably known to the manufacturer
adverse device events summarized in an devices file with FDA an annual report and evaluating the cause of the event
annual report will alert FDA to trends for 3 consecutive years, this would be (§ 803.50(b) (21 CFR 803.50(b)). In
or clusters of events that might be a less burdensome than the current addition, manufacturers of medical
safety issue otherwise unreported under postapproval requirements under 21 devices are required to submit to FDA
the MDR regulation. The report should CFR part 814, subpart E, including the individual adverse event reports of
also include any subsequent change to submission of periodic reports under 21 death, serious injury, and malfunctions
the preamendments class III device CFR 814.84. (§ 803.50).
requiring a 30-day notice in accordance Collecting or transfusing facilities, the
with 21 CFR 814.39(f). intended users of the device, and the In the special control guidance
Reclassification of this device from device manufacturers have certain document, FDA recommends that
class III to class II relieves responsibilities under the Federal manufacturers include in their three
manufacturers of the burden of regulations. For example, collecting or annual reports a summary of adverse
complying with the premarket approval transfusing facilities are required to reactions maintained by the collecting
requirements of section 515 of the FD&C maintain records of any reports of or transfusing facility or similar reports
Act (21 U.S.C. 360e) and may permit complaints of adverse reactions (21 CFR of adverse events collected.
small potential competitors to enter the 606.170), while the device manufacturer FDA estimates the burden of this
marketplace by reducing the burden. is responsible for conducting an collection of information as follows:
Although the special control guidance investigation of each event that is
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Reporting activity responses per burden per Total hours
respondents responses
respondent response
Annual Report ...................................................................... 3 1 3 5 15
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on FDA records, there are determined the regulatory review period Electronic Submissions
approximately three manufacturers of for OFEV and is publishing this notice
automated blood cell separator devices. of that determination as required by Submit electronic comments in the
We estimate that the manufacturers will law. FDA has made the determination following way:
spend approximately 5 hours preparing because of the submission of an • Federal eRulemaking Portal:
and submitting the annual report. The application to the Director of the U.S. https://www.regulations.gov. Follow the
total burden hours are reduced from Patent and Trademark Office (USPTO), instructions for submitting comments.
previous collections due to a decrease in Department of Commerce, for the Comments submitted electronically,
the number of manufacturers. extension of a patent which claims that including attachments, to https://
Other burden hours required for human drug product. www.regulations.gov will be posted to
§ 864.9245 are reported and approved DATES: Anyone with knowledge that any the docket unchanged. Because your
under OMB control number 0910–0120 of the dates as published (in the comment will be made public, you are
(premarket notification submission SUPPLEMENTARY INFORMATION section) are solely responsible for ensuring that your
510(k), 21 CFR part 807, subpart E), and incorrect may submit either electronic comment does not include any
OMB control number 0910–0437 (MDR, or written comments and ask for a confidential information that you or a
part 803). redetermination by April 23, 2018. Late, third party may not wish to be posted,
untimely filed comments will not be such as medical information, your or
Dated: February 15, 2018.
considered. Electronic comments must anyone else’s Social Security number, or
Leslie Kux, confidential business information, such
be submitted on or before April 23,
Associate Commissioner for Policy. as a manufacturing process. Please note
2018. The https://www.regulations.gov
[FR Doc. 2018–03613 Filed 2–21–18; 8:45 am] electronic filing system will accept that if you include your name, contact
BILLING CODE 4164–01–P comments until midnight Eastern Time information, or other information that
at the end of April 23, 2018. Comments identifies you in the body of your
received by mail/hand delivery/courier comments, that information will be
DEPARTMENT OF HEALTH AND (for written/paper submissions) will be posted on https://www.regulations.gov.
HUMAN SERVICES considered timely if they are • If you want to submit a comment
postmarked or the delivery service with confidential information that you
Food and Drug Administration
acceptance receipt is on or before that do not wish to be made available to the
[Docket No. FDA–2015–E–4020] date. Furthermore, any interested public, submit the comment as a
person may petition FDA for a written/paper submission and in the
Determination of Regulatory Review determination regarding whether the manner detailed (see ‘‘Written/Paper
Period for Purposes of Patent applicant for extension acted with due Submissions’’ and ‘‘Instructions’’).
daltland on DSKBBV9HB2PROD with NOTICES
Extension; OFEV diligence during the regulatory review
period by August 21, 2018. See Written/Paper Submissions
AGENCY: Food and Drug Administration,
HHS. ‘‘Petitions’’ in the SUPPLEMENTARY Submit written/paper submissions as
INFORMATION section for more follows:
ACTION: Notice. information. • Mail/Hand delivery/Courier (for
SUMMARY: The Food and Drug ADDRESSES: You may submit comments written/paper submissions): Dockets
Administration (FDA or the Agency) has as follows: Management Staff (HFA–305), Food and
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Document Created: 2018-02-22 02:51:01
Document Modified: 2018-02-22 02:51:01
| 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 | Submit either electronic or written comments on the collection of information by April 23, 2018. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 83 FR 7745 |
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