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

FDA’s guidance document states that 

the documentation condition would be 

met if the prescription for the 

compounded radiopharmaceutical 

makes clear that the prescriber 

identified the relevant change between 

the approved radiopharmaceutical and 

the compounded radiopharmaceutical 

and the clinical difference that the 

change produces for the patient. 

(Comment 3) One commenter 

recommended that the guidance 

document require written 

documentation when a commercially 

manufactured radiopharmaceutical is 

compounded for a patient because the 

radiopharmaceutical is unavailable due 

to a drug shortage. 

(Response 3) The guidance document 

explains that FDA does not consider a 

compounded radiopharmaceutical to be 

essentially a copy of a marketed FDAapproved radiopharmaceutical if the 

FDA-approved radiopharmaceutical is 

on FDA’s drug shortage list (see section 

506E of the FD&C Act (21 U.S.C. 356e)) 

at the time of compounding and 

distribution. FDA maintains a database 

for drug shortages. If the Agency 

identifies a compounded 

radiopharmaceutical that has the 

characteristics of a drug that is 

‘‘essentially a copy,’’ FDA intends to 

review its database to determine 

whether there was a shortage of the 

approved radiopharmaceutical at the 

time of compounding and distribution. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Type of reporting Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average burden 

per disclosure Total hours 

Consultation between the compounder and prescriber and the notation on the prescription or 

order documenting the prescriber’s determination 

of clinical difference.

10 25 250 0.05 (3 minutes) ........ 12.5 

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

The total estimated third-party 

disclosure burden for the guidance 

document is shown above. 

We estimate that a total of 

approximately 10 compounders 

annually (‘‘No. of Respondents’’ in table 

1, line 1) will consult a prescriber to 

determine whether they decided that 

the compounded radiopharmaceutical 

has a change that produces a clinical 

difference for an identified individual 

patient as compared to the comparable 

approved radiopharmaceutical. We 

estimate that compounders will 

document this determination on 

approximately 250 prescriptions or 

orders for compounded 

radiopharmaceuticals (‘‘Total Annual 

Disclosures’’ in table 1, line 1). We 

estimate that the consultation between 

the compounder and the prescriber and 

noting this determination on each 

prescription or order that does not 

already document this determination 

will take approximately 3 minutes per 

prescription or order. 

In the Federal Register of December 

29, 2016 (81 FR 96011), FDA also 

estimated the annual recordkeeping 

burden for maintaining records of 

prescriptions or orders documenting 

certain information from prescribers. 

While acquiring additional information 

from the public about State pharmacy 

practices since we published 81 FR 

96011, FDA has determined that 

because the time, effort, and financial 

resources necessary to comply with this 

collection of information would be 

incurred by compounders in the normal 

course of their activities, it is excluded 

from the definition of ‘‘burden’’ under 5 

CFR 1320.3(b)(2). FDA understands that 

maintaining records of prescriptions for 

compounded drug products is part of 

the usual course of the practice of 

compounding and selling drugs and is 

required by States’ pharmacy laws and 

other State laws governing record 

keeping by healthcare professionals and 

healthcare facilities. 

Dated: July 10, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–15095 Filed 7–13–18; 8:45 am] 

BILLING CODE 4164–01–P 

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. 


sradovich on DSK3GMQ082PROD with NOTICES
32884 Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices 

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 (§ 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 

(§ 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 

(§ 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

Reporting activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total 

hours 

Annual Report ...................................................................... 3 1 3 5 15 

1There 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 

§ 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Declaration Regarding Emergency Use 

of Treatment for Uncontrolled 

Hemorrhage Due to Agents of Military 

Combat 

AGENCY: Office of the Secretary, 

Department of Health and Human 

Services. 

ACTION: Notice. 

SUMMARY: The Secretary of Health and 

Human Services (HHS) is issuing this 

notice pursuant to the Federal Food, 

Drug, and Cosmetic (FD&C) Act. On 

June 7, 2018, Patrick M. Shanahan, 

Deputy Secretary of Defense, 

determined in accordance with the 

Federal Food, Drug and Cosmetic Act, 

as delegated by the Secretary of Defense, 

that there is a military emergency or 

significant potential for a military 

emergency, involving a heightened risk 

to U.S. military forces of an attack with 

an agent or agents that may cause, or are 

otherwise associated with an 

imminently life-threatening and specific 

risk to those forces. More specifically, 

U.S. Forces are now deployed in 

multiple locations where they serve at 


sradovich on DSK3GMQ082PROD with NOTICES