83 FR 32883 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry and FDA Staff-Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 136 (July 16, 2018)

Page Range		32883-32884
FR Document		2018-15089

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.

Federal Register, Volume 83 Issue 136 (Monday, July 16, 2018)

[Federal Register Volume 83, Number 136 (Monday, July 16, 2018)]
[Notices]
[Pages 32883-32884]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-15089]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
and FDA Staff--Class II Special Controls Guidance Document: Automated
Blood Cell Separator Device Operating by Centrifugal or Filtration
Separation Principle

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.

DATES: Fax written comments on the collection of information by August
15, 2018.

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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
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.

[[Page 32884]]

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 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.
In the Federal Register of February 22, 2018, (83 FR 7745), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received but did not respond
to any of the four information collection topics solicited and is
therefore not discussed here.
We estimate the burden of the information collection 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: July 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15089 Filed 7-13-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices 32883

FDA’s guidance document states that documentation when a commercially at the time of compounding and
the documentation condition would be manufactured radiopharmaceutical is distribution. FDA maintains a database
met if the prescription for the compounded for a patient because the for drug shortages. If the Agency
compounded radiopharmaceutical radiopharmaceutical is unavailable due identifies a compounded
makes clear that the prescriber to a drug shortage. radiopharmaceutical that has the
identified the relevant change between (Response 3) The guidance document characteristics of a drug that is
the approved radiopharmaceutical and explains that FDA does not consider a ‘‘essentially a copy,’’ FDA intends to
the compounded radiopharmaceutical compounded radiopharmaceutical to be review its database to determine
and the clinical difference that the essentially a copy of a marketed FDA- whether there was a shortage of the
change produces for the patient. approved radiopharmaceutical if the approved radiopharmaceutical at the
(Comment 3) One commenter FDA-approved radiopharmaceutical is time of compounding and distribution.
recommended that the guidance on FDA’s drug shortage list (see section FDA estimates the burden of this
document require written 506E of the FD&C Act (21 U.S.C. 356e)) collection of information as follows:

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
Number of disclosures Total annual Average burden
Type of reporting Total hours
respondents per disclosures per disclosure
respondent

Consultation between the compounder and pre- 10 25 250 0.05 (3 minutes) ........ 12.5
scriber and the notation on the prescription or
order documenting the prescriber’s determination
of clinical difference.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The total estimated third-party CFR 1320.3(b)(2). FDA understands that (OMB) for review and clearance under
disclosure burden for the guidance maintaining records of prescriptions for the Paperwork Reduction Act of 1995.
document is shown above. compounded drug products is part of
We estimate that a total of the usual course of the practice of DATES: Fax written comments on the
approximately 10 compounders compounding and selling drugs and is collection of information by August 15,
annually (‘‘No. of Respondents’’ in table required by States’ pharmacy laws and 2018.
1, line 1) will consult a prescriber to other State laws governing record ADDRESSES: To ensure that comments on
determine whether they decided that keeping by healthcare professionals and the information collection are received,
the compounded radiopharmaceutical healthcare facilities. OMB recommends that written
has a change that produces a clinical comments be faxed to the Office of
Dated: July 10, 2018.
difference for an identified individual
Leslie Kux, Information and Regulatory Affairs,
patient as compared to the comparable
approved radiopharmaceutical. We Associate Commissioner for Policy. OMB, Attn: FDA Desk Officer, Fax: 202–
estimate that compounders will [FR Doc. 2018–15095 Filed 7–13–18; 8:45 am] 395–7285, or emailed to oira_
document this determination on BILLING CODE 4164–01–P submission@omb.eop.gov. All
approximately 250 prescriptions or comments should be identified with the
orders for compounded OMB control number 0910–0594. Also
radiopharmaceuticals (‘‘Total Annual DEPARTMENT OF HEALTH AND include the FDA docket number found
Disclosures’’ in table 1, line 1). We HUMAN SERVICES in brackets in the heading of this
estimate that the consultation between document.
the compounder and the prescriber and Food and Drug Administration
noting this determination on each FOR FURTHER INFORMATION CONTACT:
[Docket No. FDA–2012–N–0115] Domini Bean, Office of Operations,
prescription or order that does not
already document this determination Food and Drug Administration, Three
Agency Information Collection
will take approximately 3 minutes per Activities; Submission for Office of White Flint North, 10A–12M, 11601
prescription or order. Management and Budget Review; Landsdown St., North Bethesda, MD
In the Federal Register of December Comment Request; Guidance for 20852, 301–796–5733, PRAStaff@
29, 2016 (81 FR 96011), FDA also Industry and FDA Staff—Class II fda.hhs.gov.
estimated the annual recordkeeping Special Controls Guidance Document:
burden for maintaining records of SUPPLEMENTARY INFORMATION: In
Automated Blood Cell Separator compliance with 44 U.S.C. 3507, FDA
prescriptions or orders documenting Device Operating by Centrifugal or
certain information from prescribers. has submitted the following proposed
Filtration Separation Principle
While acquiring additional information collection of information to OMB for
from the public about State pharmacy AGENCY: Food and Drug Administration, review and clearance.
sradovich on DSK3GMQ082PROD with NOTICES

practices since we published 81 FR HHS.
96011, FDA has determined that ACTION: Notice.
because the time, effort, and financial
resources necessary to comply with this SUMMARY: The Food and Drug
collection of information would be Administration (FDA or we) is
incurred by compounders in the normal announcing that a proposed collection
course of their activities, it is excluded of information has been submitted to the
from the definition of ‘‘burden’’ under 5 Office of Management and Budget

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32884 Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices

Guidance for Industry and FDA Staff— FD&C Act should be included in the CFR part 814, subpart E, including the
Class II Special Controls Guidance annual report. Also, a manufacturer of a submission of periodic reports under 21
Document: Automated Blood Cell device determined to be substantially CFR 814.84.
Separator Device Operating by equivalent to the centrifugal or Collecting or transfusing facilities, the
Centrifugal or Filtration Separation filtration-based automated cell separator intended users of the device, and the
Principle device intended for the routine device manufacturers have certain
collection of blood and blood responsibilities under the Federal
OMB Control Number 0910–0594—
components should comply with the regulations. For example, collecting or
Extension
same general and special controls. transfusing facilities are required to
Under the Safe Medical Devices Act The annual report should include, at maintain records of any reports of
of 1990 (Pub. L. 101–629), FDA may a minimum, a summary of anticipated complaints of adverse reactions (21 CFR
establish special controls, including and unanticipated adverse events that 606.170), while the device manufacturer
performance standards, postmarket have occurred and that are not required is responsible for conducting an
surveillance, patient registries, to be reported by manufacturers under investigation of each event that is
guidelines, and other appropriate Medical Device Reporting (MDR) (part reasonably known to the manufacturer
actions it believes necessary to provide 803 (21 CFR part 803)). The reporting of and evaluating the cause of the event
reasonable assurance of the safety and adverse device events summarized in an (§ 803.50(b) (21 CFR 803.50(b))). In
effectiveness of the device. The special annual report will alert FDA to trends addition, manufacturers of medical
control guidance serves as the special or clusters of events that might be a devices are required to submit to FDA
control for the automated blood cell safety issue otherwise unreported under individual adverse event reports of
separator device operating by the MDR regulation. The report should death, serious injury, and malfunctions
centrifugal or filtration separation also include any subsequent change to (§ 803.50).
principle intended for the routine the preamendments class III device In the special control guidance
collection of blood and blood requiring a 30-day notice in accordance document, FDA recommends that
components (§ 864.9245 (21 CFR with 21 CFR 814.39(f). manufacturers include in their three
864.9245)). Reclassification of this device from annual reports a summary of adverse
For currently marketed products not class III to class II relieves reactions maintained by the collecting
approved under the premarket approval manufacturers of the burden of or transfusing facility or similar reports
process, the manufacturer should file complying with the premarket approval of adverse events collected.
with FDA for 3 consecutive years an requirements of section 515 of the FD&C In the Federal Register of February
annual report on the anniversary date of Act (21 U.S.C. 360e) and may permit 22, 2018, (83 FR 7745), FDA published
the device reclassification from class III small potential competitors to enter the a 60-day notice requesting public
to class II or on the anniversary date of marketplace by reducing the burden. comment on the proposed collection of
the 510(k) of the Federal Food, Drug, Although the special control guidance information. One comment was received
and Cosmetic Act (FD&C Act) (21 U.S.C. recommends that manufacturers of these but did not respond to any of the four
360(k)) clearance. Any subsequent devices file with FDA an annual report information collection topics solicited
change to the device requiring the for 3 consecutive years, this would be and is therefore not discussed here.
submission of a premarket notification less burdensome than the current We estimate the burden of the
in accordance with section 510(k) of the postapproval requirements under 21 information collection as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual Total
Reporting activity responses per burden per
respondents responses hours
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 Dated: July 9, 2018. SUMMARY: The Secretary of Health and
approximately three manufacturers of Leslie Kux, Human Services (HHS) is issuing this
automated blood cell separator devices. Associate Commissioner for Policy. notice pursuant to the Federal Food,
We estimate that the manufacturers will [FR Doc. 2018–15089 Filed 7–13–18; 8:45 am] Drug, and Cosmetic (FD&C) Act. On
spend approximately 5 hours preparing BILLING CODE 4164–01–P June 7, 2018, Patrick M. Shanahan,
and submitting the annual report. The Deputy Secretary of Defense,
total burden hours are reduced from determined in accordance with the
previous collections due to a decrease in DEPARTMENT OF HEALTH AND Federal Food, Drug and Cosmetic Act,
the number of manufacturers. HUMAN SERVICES as delegated by the Secretary of Defense,
that there is a military emergency or
Other burden hours required for Declaration Regarding Emergency Use significant potential for a military
§ 864.9245 are reported and approved of Treatment for Uncontrolled emergency, involving a heightened risk
sradovich on DSK3GMQ082PROD with NOTICES

under OMB control number 0910–0120 Hemorrhage Due to Agents of Military to U.S. military forces of an attack with
(premarket notification submission Combat an agent or agents that may cause, or are
510(k), 21 CFR part 807, subpart E), and otherwise associated with an
AGENCY: Office of the Secretary,
OMB control number 0910–0437 (MDR, imminently life-threatening and specific
Department of Health and Human
part 803). Services. risk to those forces. More specifically,
U.S. Forces are now deployed in
ACTION: Notice.
multiple locations where they serve at

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Document Created: 2018-07-14 00:54:29
Document Modified: 2018-07-14 00:54:29

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 August 15, 2018.
Contact		Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected]
FR Citation		83 FR 32883

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 136 (July 16, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration