Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Notices 17483 

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 0910–0191. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

7726, Ila.Mizrachi@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. 

Notice of Participation—21 CFR 12.45 

(OMB Control Number 0910–0191)— 

Extension 

Section 12.45 (21 CFR 12.45), issued 

under section 701 of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 371), 

sets forth the format and procedures for 

any interested person to file a petition 

to participate in a formal evidentiary 

hearing, either personally or through a 

representative. Section 12.45 requires 

that any person filing a notice of 

participation state their specific interest 

in the proceedings, including the 

specific issues of fact about which the 

person desires to be heard. This section 

also requires that the notice include a 

statement that the person will present 

testimony at the hearing and will 

comply with specific requirements in 21 

CFR 12.85, or, in the case of a hearing 

before a Public Board of Inquiry, 

concerning disclosure of data and 

information by participants (21 CFR 

13.25). In accordance with § 12.45(e), 

the presiding officer may omit a 

participant’s appearance. 

The presiding officer and other 

participants will use the collected 

information in a hearing to identify 

specific interests to be presented. This 

preliminary information serves to 

expedite the pre-hearing conference and 

commits participation. 

The respondents are individuals or 

households, State or local governments, 

not-for-profit institutions and 

businesses, or other for-profit groups 

and institutions. 

In the Federal Register of September 

9, 2011 (76 FR 55918), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

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 

12.45 .................................................................................... 4 1 4 3 12 

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

The burden estimates for this 

collection of information are based on 

Agency records and experience over the 

past 3 years. 

Dated: March 20, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–7137 Filed 3–23–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0776] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Reclassification 

Petitions for Medical Devices 

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 April 25, 

2012. 

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 0910–0138 and 

also include the FDA docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@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. 

Reclassification Petitions for Medical 

Devices—21 CFR 860.123 (OMB Control 

Number 0910–0138)—Extension 

Under sections 513(e) and (f), 514(b), 

515(b), and 520(l) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 360c(e) and (f), 360d(b), 360e(b), 

and 360j(l)) and part 860 (21 CFR part 

860), subpart C, FDA has responsibility 

to collect data and information 

contained in reclassification petitions. 

The reclassification provisions of the 

FD&C Act allow any person to petition 

for reclassification of a device from any 

of the three classes i.e., I, II, and III, to 

another class. The reclassification 

procedure regulation requires the 

submission of specific data when a 

manufacturer is petitioning for 

reclassification. This includes a 

‘‘Supplemental Data Sheet,’’ Form FDA 

3427, and a ‘‘Classification 

Questionnaire,’’ Form FDA 3429. Both 

forms contain a series of questions 

concerning the safety and effectiveness 

of the device type. Further, the 

reclassification content regulation 

(§ 860.123) requires the submission of 

valid scientific evidence demonstrating 

that the proposed reclassification will 

provide a reasonable assurance of safety 

and effectiveness of the device type for 

its indications for use. Thus, the 

reclassification provisions of the FD&C 

Act serve primarily as a vehicle for 

manufacturers to seek reclassification 

from a higher to a lower class, thereby 

reducing the regulatory requirements 

applicable to a particular device type, or 


tkelley on DSK3SPTVN1PROD with NOTICES
17484 Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Notices 

1This document addresses the information 

collection in current part 207. In the Federal 

Register of August 29, 2006 (the 2006 proposed 

rule) (71 FR 51276), FDA proposed to revise part 

207. The proposed revisions would reorganize, 

consolidate, clarify, and modify current regulations 

concerning who must register establishments and 

list, and describes when and how to register and list 

and what information must be submitted for 

registration and listing. In addition, the proposal 

would make certain changes to the National Drug 

Code (NDC) system and would require the 

appropriate NDC number to appear on the labels for 

drugs subject to the listing requirements. The 

proposed regulations generally also require the 

electronic submission of all registration and most 

listing information. The 2006 proposed rule 

requested comments on the information collection 

for revised part 207. When the proposal is finalized, 

the information collection for a revised part 207 

will replace the information collection in this 

document. 

to seek reclassification from a lower to 

a higher class, thereby increasing the 

regulatory requirements applicable to 

that device type. If approved, petitions 

requesting classification from class III to 

class II or class I provide an alternative 

route to market in lieu of premarket 

approval for class III devices. If 

approved, petitions requesting 

reclassification from class I or II, to a 

different class, may increase 

requirements. 

In the Federal Register of November 

14, 2011 (76 FR 70460), 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

21 CFR section Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

860.123 ................................................................................ 6 1 6 500 3,000 

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

Based on the last 3 years, and actual 

reclassification petitions received, FDA 

anticipates that six petitions will be 

submitted each year. The time required 

to prepare and submit a reclassification 

petition, including the time needed to 

assemble supporting data, averages 500 

hours per petition. This average is based 

upon estimates by FDA administrative 

and technical staff who: (1) Are familiar 

with the requirements for submission of 

a reclassification petition, (2) have 

consulted and advised manufacturers on 

these requirements, and (3) have 

reviewed the documentation submitted. 

Dated: March 20, 2012. 

David Dorsey, 

Acting Associate Commissioner for Policy and 

Planning. 

[FR Doc. 2012–7142 Filed 3–23–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0742] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Registration of 

Producers of Drugs and Listing of 

Drugs in Commercial Distribution 

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 April 25, 

2012. 

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 0910–0045. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Juanmanuel Vilela, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–7651, 

juanmanuel.vilela@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. 

Registration of Producers of Drugs and 

Listing of Drugs in Commercial 

Distribution—21 CFR Part 207—(OMB 

Control Number 0910–0045)—Extension 

Requirements for drug establishment 

registration and drug listing are set forth 

in section 510 of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 360); section 351 of the 

Public Health Service Act; and part 207 

(21 CFR part 207). Fundamental to 

FDA’s mission to protect the public 

health is the collection of this 

information, which is used for 

important activities such as postmarket 

surveillance for serious adverse drug 

reactions, inspection of drug 

manufacturing and processing facilities, 

and monitoring of drug products 

imported into the United States. 

Comprehensive, accurate, and up-todate information is critical to 

conducting these activities with 

efficiency and effectiveness. 

Under section 510 of the FD&C Act, 

FDA is authorized to establish a system 

for registration of producers of drugs 

and for listing of drugs in commercial 

distribution. To implement section 510 

of the FD&C Act, FDA issued part 207.1

Under current § 207.20, manufacturers, 

repackers, and relabelers that engage in 

the manufacture, preparation, 

propagation, compounding, or 

processing of human or veterinary drugs 

and biological products, including bulk 

drug substances and bulk drug 

substances for prescription 

compounding, and drug premixes as 

well as finished dosage forms, whether 

prescription or over-the-counter, are 

required to register their establishment. 

In addition, manufacturers, repackers, 

and relabelers are required to submit a 

listing of every drug or biological 

product in commercial distribution. 

Owners or operators of establishments 

that distribute under their own label or 

trade name a drug product 

manufactured by a registered 

establishment are not required either to 

register or list. However, distributors 

may elect to submit drug listing 

information in lieu of the registered 

establishment that manufactures the 

drug product. Foreign drug 


tkelley on DSK3SPTVN1PROD with NOTICES