80 FR 34682 - Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; 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 80, Issue 116 (June 17, 2015)

Page Range		34682-34683
FR Document		2015-14889

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.

Federal Register, Volume 80 Issue 116 (Wednesday, June 17, 2015)

[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)]
[Notices]
[Pages 34682-34683]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-14889]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0115]

Agency Information Collection Activities; Proposed Collection;
Submission for Office of Management and Budget Review; 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) 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 July
17, 2015.

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 0910-0594.
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, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, 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.

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 to support the reclassification from class III
to class II of the automated blood cell separator device operating on a
centrifugal separation principle intended for the routine collection of
blood and blood components as well as the special control for the
automated blood cell separator device operating on a filtration
separation principle intended for the routine collection of blood and
blood components reclassified as class II (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 (the FD&C Act) (21 U.S.C. 360) 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

[[Page 34683]]

Medical Device Reporting (MDR) (part 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.
Reclassification of this device from class III to class II for the
intended use of routine collection of blood and blood components
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 part 814, subpart E (21 CFR part 814,
subpart E), including the submission of periodic reports under Sec.
814.84.
Collecting or transfusing facilities and manufacturers have certain
responsibilities under 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
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)). 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, in addition to those
required under the MDR regulation. The MedWatch medical device
reporting code instructions (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm106737.htm) contains a
comprehensive list of adverse events associated with device use,
including most of those events that we recommend summarizing in the
annual report.
In the Federal Register of January 29, 2015 (80 FR 4927), 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
Reporting activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Report...................................................... 4 1 4 5 20
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on FDA records, there are approximately four manufacturers of
automated blood cell separator devices. The estimated average burden
per response is based on the time that the manufacturers will spend
preparing and submitting the annual report.
Other burden hours required for Sec. 864.9245 are reported and
approved under OMB control number 0910-0120 (premarket notification
submission 501(k), 21 CFR part 807, subpart E), and OMB control number
0910-0437 (MDR, part 803).

Dated: June 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14889 Filed 6-16-15; 8:45 am]
BILLING CODE 4164-01-P

34682 Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
21 CFR section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping

179.25(e), large processors ............................. 4 300 1,200 1 1,200
179.25(e), small processors ............................ 4 30 120 1 120

Total .......................................................... ............................ ............................ ............................ ............................ 1,320
1 There are no capital costs or operating and maintenance costs associated with this collection.

We base our estimate of burden for DEPARTMENT OF HEALTH AND Guidance for Industry and FDA Staff—
the recordkeeping provisions of HUMAN SERVICES Class II Special Controls Guidance
§ 179.25(e) on our experience regulating Document: Automated Blood Cell
the safe use of radiation as a direct food Food and Drug Administration Separator Device Operating by
additive. The number of firms who [Docket No. FDA–2012–N–0115] Centrifugal or Filtration Separation
process food using irradiation is Principle (OMB Control Number 0910–
extremely limited. We estimate that Agency Information Collection 0594)—Extension
there are four irradiation plants whose Activities; Proposed Collection; Under the Safe Medical Devices Act
business is devoted primarily (i.e., Submission for Office of Management of 1990 (Pub. L. 101–629), FDA may
approximately 100 percent) to and Budget Review; Guidance for establish special controls, including
irradiation of food and other agricultural Industry and Food and Drug performance standards, postmarket
products. Four other firms also irradiate Administration Staff—Class II Special surveillance, patient registries,
small quantities of food. We estimate Controls Guidance Document: guidelines, and other appropriate
that this irradiation accounts for no Automated Blood Cell Separator actions it believes necessary to provide
more than 10 percent of the business for Device Operating by Centrifugal or reasonable assurance of the safety and
Filtration Principle effectiveness of the device. The special
each of these firms. Therefore, the
control guidance serves to support the
average estimated burden is based on AGENCY: Food and Drug Administration,
reclassification from class III to class II
four facilities devoting 100 percent of HHS. of the automated blood cell separator
their business to food irradiation (4 × ACTION: Notice. device operating on a centrifugal
300 hours = 1200 hours for separation principle intended for the
recordkeeping annually), and four SUMMARY: The Food and Drug
routine collection of blood and blood
facilities devoting 10 percent of their Administration (FDA) is announcing
components as well as the special
business to food irradiation (4 × 30 that a proposed collection of
control for the automated blood cell
hours = 120 hours for recordkeeping information has been submitted to the
separator device operating on a filtration
annually). Office of Management and Budget
separation principle intended for the
(OMB) for review and clearance under
No burden has been estimated for the routine collection of blood and blood
the Paperwork Reduction Act of 1995.
labeling requirements in §§ 179.21(b)(1), components reclassified as class II
DATES: Fax written comments on the (§ 864.9245 (21 CFR 864.9245)).
179.21(b)(2) and 179.26(c) because the
collection of information by July 17, For currently marketed products not
information to be disclosed is 2015.
information that has been supplied by approved under the premarket approval
FDA. Under 5 CFR 1320.3(c)(2), the ADDRESSES: To ensure that comments on process, the manufacturer should file
public disclosure of information the information collection are received, with FDA, for 3 consecutive years, an
OMB recommends that written annual report on the anniversary date of
originally supplied by the Federal
comments be faxed to the Office of the device reclassification from class III
Government to the recipient for the
Information and Regulatory Affairs, to class II or on the anniversary date of
purpose of disclosure to the public is
OMB, Attn: FDA Desk Officer, FAX: the 510(k) of the Federal Food, Drug,
not subject to review by the Office of and Cosmetic Act (the FD&C Act) (21
202–395–7285, or emailed to oira_
Management and Budget under the U.S.C. 360) clearance. Any subsequent
submission@omb.eop.gov. All
Paperwork Reduction Act. change to the device requiring the
comments should be identified with the
Dated: June 10, 2015. OMB control number 0910–0594. Also submission of a premarket notification
Leslie Kux, include the FDA docket number found in accordance with section 510(k) of the
Associate Commissioner for Policy. in brackets in the heading of this FD&C Act should be included in the
document. annual report. Also, a manufacturer of a
[FR Doc. 2015–14886 Filed 6–16–15; 8:45 am]
device determined to be substantially
BILLING CODE 4164–01–P FOR FURTHER INFORMATION CONTACT: FDA
equivalent to the centrifugal or
PRA Staff, Office of Operations, Food
filtration-based automated cell separator
and Drug Administration, 8455
device intended for the routine
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Colesville Rd., COLE–14526, Silver
collection of blood and blood
Spring, MD 20993–0002, PRAStaff@
components should comply with the
fda.hhs.gov.
same general and special controls.
SUPPLEMENTARY INFORMATION: In The annual report should include, at
compliance with 44 U.S.C. 3507, FDA a minimum, a summary of anticipated
has submitted the following proposed and unanticipated adverse events that
collection of information to OMB for have occurred and that are not required
review and clearance. to be reported by manufacturers under

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Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices 34683

Medical Device Reporting (MDR) (part 814, subpart E (21 CFR part 814, subpart annual reports a summary of adverse
803 (21 CFR part 803)). The reporting of E), including the submission of periodic reactions maintained by the collecting
adverse device events summarized in an reports under § 814.84. or transfusing facility, or similar reports
annual report will alert FDA to trends Collecting or transfusing facilities and of adverse events collected, in addition
or clusters of events that might be a manufacturers have certain to those required under the MDR
safety issue otherwise unreported under responsibilities under Federal regulation. The MedWatch medical
the MDR regulation. regulations. For example, collecting or device reporting code instructions
Reclassification of this device from transfusing facilities are required to (http://www.fda.gov/MedicalDevices/
class III to class II for the intended use maintain records of any reports of DeviceRegulationandGuidance/
of routine collection of blood and blood complaints of adverse reactions (21 CFR GuidanceDocuments/ucm106737.htm)
components relieves manufacturers of 606.170), while the manufacturer is contains a comprehensive list of adverse
the burden of complying with the responsible for conducting an events associated with device use,
premarket approval requirements of investigation of each event that is including most of those events that we
section 515 of the FD&C Act (21 U.S.C. reasonably known to the manufacturer recommend summarizing in the annual
360e), and may permit small potential and evaluating the cause of the event report.
competitors to enter the marketplace by (§ 803.50(b)). In addition, manufacturers In the Federal Register of January 29,
reducing the burden. Although the of medical devices are required to 2015 (80 FR 4927), FDA published a 60-
special control guidance recommends submit to FDA individual adverse event day notice requesting public comment
that manufacturers of these devices file reports of death, serious injury, and on the proposed collection of
with FDA an annual report for 3 malfunctions (§ 803.50). information. No comments were
consecutive years, this would be less In the special control guidance received.
burdensome than the current document, FDA recommends that FDA estimates the burden of this
postapproval requirements under part manufacturers include in their three collection of information as follows:

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 ...................................................................... 4 1 4 5 20
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on FDA records, there are SUMMARY: In compliance with section from the Title X centers on efforts
approximately four manufacturers of 3506(c)(2)(A) of the Paperwork related to (1) assisting individuals in
automated blood cell separator devices. Reduction Act of 1995, the Office of the obtaining health insurance; (2)
The estimated average burden per Secretary (OS), Department of Health partnerships with primary care
response is based on the time that the and Human Services, announces plans providers; (3) availability and use of
manufacturers will spend preparing and to submit a new Information Collection electronic health records; (4) monitoring
submitting the annual report. Request (ICR), described below, to the patient care quality; (5) factors affecting
Other burden hours required for Office of Management and Budget revenue sources; and (6) the way that
§ 864.9245 are reported and approved (OMB). Comments submitted during the sites conduct analyses to consider the
under OMB control number 0910–0120 first public review of this ICR will be cost of providing services.
(premarket notification submission provided to OMB. OMB will accept Need and Proposed Use of the
501(k), 21 CFR part 807, subpart E), and further comments from the public on Information: The Title X Family
OMB control number 0910–0437 (MDR, this ICR during the review and approval Planning Program (‘‘Title X program’’ or
part 803). period. ‘‘program’’) is the only Federal grant
Dated: June 10, 2015. DATES: Comments on the ICR must be program dedicated solely to providing
Leslie Kux, received on or before July 17, 2015. individuals with comprehensive family
planning and related preventive health
Associate Commissioner for Policy. ADDRESSES: Submit your comments to
services (e.g., screening for breast and
[FR Doc. 2015–14889 Filed 6–16–15; 8:45 am] Information.CollectionClearance@
cervical cancer, sexually transmitted
BILLING CODE 4164–01–P hhs.gov or by calling (202) 690–6162.
diseases (STDs), and human
FOR FURTHER INFORMATION CONTACT: immunodeficiency virus [HIV]). By law,
Information Collection Clearance staff, priority is given to persons from low-
DEPARTMENT OF HEALTH AND Information.CollectionClearance@ income families (Section 1006[c] of Title
HUMAN SERVICES hhs.gov or (202) 690–6162. X of the Public Health Service Act, 42
SUPPLEMENTARY INFORMATION: When U.S.C. 300). The Office of Population
Office of the Secretary
submitting comments or requesting Affairs (OPA) within the Office of the
[Document Identifier: HHS–OS–0990–new– information, please include the Assistant Secretary for Health
asabaliauskas on DSK5VPTVN1PROD with NOTICES

30D] document identifier HHS–OS–0990– administers the Title X program.
new–30D for reference. Information The American health care system is
Agency Information Collection Collection Request Title: Title X experiencing unprecedented levels of
Activities; Proposed Collection; Public Sustainability Assessment Tool for change as a result of the Patient
Comment Request Grantees and Service Sites. Protection and Affordable Care Act
AGENCY: Office of the Secretary, HHS. Abstract: The Office of Population (ACA). The exact impact of these health
Affairs within the Office of the Assistant system changes to Title X centers needs
ACTION: Notice.
Secretary for Health seeks to collect data to be assessed in order to ensure the

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Document Created: 2015-12-15 14:23:18
Document Modified: 2015-12-15 14:23:18

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 July 17, 2015.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 34682

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 116 (June 17, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration