Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices 78443 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0998] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Regulations for In 

Vivo Radiopharmaceuticals Used for 

Diagnosis and Monitoring 

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 January 29, 

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 0910–0409. 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. 

Regulations for In Vivo 

Radiopharmaceuticals Used for 

Diagnosis and Monitoring—21 CFR Part 

315—(OMB Control Number 0910– 

0409)—Extension 

FDA is requesting OMB approval of 

the information collection requirements 

contained in 21 CFR 315.4, 315.5, and 

315.6. These regulations require 

manufacturers of diagnostic 

radiopharmaceuticals to submit 

information that demonstrates the safety 

and effectiveness of a new diagnostic 

radiopharmaceutical or of a new 

indication for use of an approved 

diagnostic radiopharmaceutical. 

In response to the requirements of 

section 122 of the Food and Drug 

Administration Modernization Act of 

1997 (Pub. L. 105–115), FDA published 

a final rule in the Federal Register of 

May 17, 1999 (64 FR 26657), amending 

its regulations by adding provisions that 

clarify the Agency’s evaluation and 

approval of in vivo 

radiopharmaceuticals used in the 

diagnosis or monitoring of diseases. The 

regulation describes the kinds of 

indications of diagnostic 

radiopharmaceuticals and some of the 

criteria that the Agency would use to 

evaluate the safety and effectiveness of 

a diagnostic radiopharmaceutical under 

section 505 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 355) (the 

FD&C Act) and section 351 of the Public 

Health Service Act (42 U.S.C. 262) (the 

PHS Act). Information about the safety 

or effectiveness of a diagnostic 

radiopharmaceutical enables FDA to 

properly evaluate the safety and 

effectiveness profiles of a new 

diagnostic radiopharmaceutical or a 

new indication for use of an approved 

diagnostic radiopharmaceutical. 

The rule clarifies existing FDA 

requirements for approval and 

evaluation of drug and biological 

products already in place under the 

authorities of the FD&C Act and the PHS 

Act. The information, which is usually 

submitted as part of a new drug 

application or biologics license 

application or as a supplement to an 

approved application, typically 

includes, but is not limited to, 

nonclinical and clinical data on the 

pharmacology, toxicology, adverse 

events, radiation safety assessments, 

and chemistry, manufacturing, and 

controls. The content and format of an 

application for approval of a new drug 

are set forth in § 314.50 (21 CFR 314.50). 

Under part 315, information required 

under the FD&C Act and needed by FDA 

to evaluate the safety and effectiveness 

of in vivo radiopharmaceuticals still 

needs to be reported. 

Based on the number of submissions 

(that is, human drug applications and/ 

or new indication supplements for 

diagnostic radiopharmaceuticals) that 

FDA receives, the Agency estimates that 

it will receive approximately two 

submissions annually from two 

applicants. The hours per response 

refers to the estimated number of hours 

that an applicant would spend 

preparing the information required by 

the regulations. Based on FDA’s 

experience, the Agency estimates the 

time needed to prepare a complete 

application for a diagnostic 

radiopharmaceutical to be 

approximately 10,000 hours, roughly 

one-fifth of which, or 2,000 hours, is 

estimated to be spent preparing the 

portions of the application that would 

be affected by these regulations. The 

regulation does not impose any 

additional reporting burden for safety 

and effectiveness information on 

diagnostic radiopharmaceuticals beyond 

the estimated burden of 2,000 hours 

because safety and effectiveness 

information is already required by 

§ 314.50 (collection of information 

approved under OMB control number 

0910–0001). In fact, clarification in 

these regulations of FDA’s standards for 

evaluation of diagnostic 

radiopharmaceuticals is intended to 

streamline overall information 

collection burdens, particularly for 

diagnostic radiopharmaceuticals that 

may have well-established, low-risk 

safety profiles, by enabling 

manufacturers to tailor information 

submissions and avoid unnecessary 

clinical studies. Table 1 contains 

estimates of the annual reporting burden 

for the preparation of the safety and 

effectiveness sections of an application 

that are imposed by existing regulations. 

This estimate does not include the 

actual time needed to conduct studies 

and trials or other research from which 

the reported information is obtained. 

In the Federal Register of July 21, 

2014 (79 FR 42337), 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: 

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78444 Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden 

per response 

Total hours 

315.4, 315.5, and 315.6 ....................................................... 2 1 2 2,000 4,000 

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

Dated: December 22, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30452 Filed 12–29–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0797] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance: Medical 

Device ISO 13485:2003 Voluntary Audit 

Report Submission Pilot Program 

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 January 29, 

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 0910–0700. 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: Medical Device ISO 

13485:2003 Voluntary Audit Report 

Submission Pilot Program—(OMB 

Control Number 0910–0700)—Extension 

Under section 228 of the Food and 

Drug Administration Amendments Act 

of 2007 (Pub. L. 110–85), as amended by 

section 704(g)(7) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

374(g)(7)), the owner or operator of an 

establishment may submit an audit 

report that assesses conformance with 

appropriate quality system standards set 

by the International Organization for 

Standardization (ISO) and identified by 

the Secretary in public notice. 

The ‘‘Guidance for Industry, Third 

Parties and FDA Staff: Medical Device 

ISO 13485:2003 Voluntary Audit Report 

Submission Program’’ describes how 

FDA’s Center for Devices and 

Radiological Health and Center for 

Biologics Evaluation and Research are 

implementing this provision of the law 

and providing public notice as required. 

The proposed collections of information 

are necessary to satisfy the previously 

mentioned statutory requirements for 

implementing this voluntary submission 

program. The collected information is 

used for setting risk-based inspectional 

priorities. 

In the Federal Register of June 26, 

2014 (79 FR 36318), 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 BURDEN1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Total 

operating and 

maintenance 

costs 

(One time only burden) First year, electronic setup and verification certificate 1 1,700 1 1,700 2 42 71,400 $51,000 

(Recurring burden) Audit report submission ....................................................... 1,700 1 1,700 3 5,100 51,000 

1There are no capital costs associated with this information collection. 

2 Respondent may already have a valid WebTrader account established for other FDA electronic submissions. 

Based on FDA’s experience with the 

founding regulatory members of the 

Global Harmonization Task Force 

(GHTF), FDA expects that the vast 

majority of manufacturers who will 

participate in the Voluntary Audit 

Report Submission Program will be 

manufacturers who are certified by 

Health Canada under ISO 13485:2003. 

In addition, FDA only expects firms 

that do not have major deficiencies or 

observations in their ISO 13485:2003 

audits to be willing to submit their audit 

reports to FDA under the Voluntary 

Audit Report Submission Program. FDA 

analyzed its inspection data from Fiscal 

Year (FY) 2013 (October 1, 2012 to 

October 1, 2013) and determined that 

the total number of inspections finalized 

in FY 2013 for medical devices was 

2,404. The breakdown for the 2,404 

compliance decisions is as follows: 

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