8262 Federal Register / Vol. 77, No. 30 / Tuesday, February 14, 2012 / Notices 

is reduced because the respondents do 

not submit a full report for each event 

they report in a quarterly summary 

report. 

The Agency believes that the majority 

of manufacturers, user facilities, and 

importers have already established 

written procedures to document 

complaints and information to meet the 

MDR requirements as part of their 

internal quality control system. There 

are an estimated 30,000 medical device 

distributors. Although they do not 

submit MDR reports, they must 

maintain records of complaints, under 

§ 803.18(d). 

The Agency has estimated that on 

average 220 user facilities, importers, 

and manufacturers would annually be 

required to establish new procedures, or 

revise existing procedures, in order to 

comply with this provision. 

Therefore, FDA estimates the onetime burden to respondents for 

establishing or revising procedures 

under § 803.17 to be 2,200 hours (220 

respondents x 10 hours). For those 

entities, a one-time burden of 10 hours 

is estimated for establishing written 

MDR procedures. The remaining 

manufacturers, user facilities, and 

importers, not required to revise their 

written procedures to comply with this 

provision, are excluded from the burden 

because the recordkeeping activities 

needed to comply with this provision 

are considered ‘‘usual and customary’’ 

under 5 CFR 1320.3(b)(2). 

Under § 803.18, 30,000 respondents 

represent distributors, importers, and 

other respondents to this information 

collection. FDA estimates that it should 

take them approximately 1.5 hours to 

complete the recordkeeping requirement 

for this section. Total hours for this 

section equal 45,000 hours. 

Dated: February 9, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–3344 Filed 2–13–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0081] 

Draft Guidance on Investigational New 

Drug Applications for Positron 

Emission Tomography Drugs; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘Investigational New Drug Applications 

for Positron Emission Tomography 

(PET) Drugs.’’ The draft guidance is 

intended to assist manufacturers of PET 

drugs in submitting investigational new 

drug applications (INDs). 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by May 14, 2012. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave. Bldg. 51, Rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Kyong (Kaye) Kang, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 2352, 

Silver Spring, MD 20993, 301–796– 

2050. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance entitled 

‘‘Investigational New Drug Applications 

for Positron Emission Tomography 

(PET) drugs.’’ The draft guidance 

summarizes the IND process for PET 

drugs, makes recommendations for how 

to submit an IND, provides advice on 

expanded access options for 

investigational PET drugs, and describes 

the process for requesting permission to 

charge for an investigational PET drug. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on the submission of INDs for PET 

drugs. It does not create or confer any 

rights for or on any person and does not 

operate to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). INDs and 

requests to charge for a drug under an 

IND are submitted to FDA under part 

312 (21 CFR part 312). NDAs and 

ANDAs are submitted to FDA under 

§§ 314.50 and 314.94 (21 CFR 314.50 

and 3.14.94). The collections of 

information in part 312 and in §§ 314.50 

and 314.94 have been approved under 

OMB control numbers 0910–0014, 

0910–0653, 0910–0651, and 0910–0001. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http:// 

www.regulations.gov. 

Dated: February 8, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–3319 Filed 2–13–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0805] 

Dermatologic and Ophthalmic Drugs 

Advisory Committee; Amendment of 

Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

The Food and Drug Administration 

(FDA) is announcing an amendment to 

the notice of the meeting of the 

Dermatologic and Ophthalmic Drugs 

mstockstill on DSK4VPTVN1PROD with NOTICES