78256 Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of respondents 

Annual 

frequency 

per 

response 

Total annual responses Hours per 

response Total hours 

540 ................................................................................................... 1 540 20/60 180 

900 ................................................................................................... 1 900 25/60 375 

200 ................................................................................................... 1 200 25/60 83 

Total .......................................................................................... 638 

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

The burden chart reflects up to 3 

pretests of 180 individuals each, 900 

participants in the main study, and 200 

participants in the followup study 

involving electronic administration. 

Dated: December 8, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–31388 Filed 12–14–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0360] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Food and Drug 

Administration Public Health 

Notification Readership Survey 

(Formerly Known as the Safety Alert/ 

Public Health Advisory Readership 

Survey) 

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 14, 

2011. 

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 e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0341. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850. 301–796– 

3793. 

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. 

Food and Drug Administration Public 

Health Notification Readership Survey 

(Formerly Known as the Safety Alert/ 

Public Health Advisory Readership 

Survey)—(OMB Control Number 0910– 

0341)—Reinstatement 

Section 705(b) of the Federal Food, 

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

375(b)) authorizes FDA to disseminate 

information concerning imminent 

danger to public health by any regulated 

product. The Center for Devices and 

Radiological Health (CDRH) 

communicates these risks to user 

communities through two publications: 

(1) The Public Health Notification 

(PHN) and (2) the Preliminary Public 

Health Notification (PPHN). The PHN is 

published when CDRH has information 

or a message to convey to health care 

practitioners in order for them to make 

informed clinical decisions about the 

use of a device or device type when that 

information may not be readily available 

to the affected target audience in the 

health care community. CDRH can make 

recommendations that will help the 

health care practitioner mitigate or 

avoid the risk. 

The PPHN is also published when 

CDRH has information to convey to 

health care practitioners in order for 

them to make informed clinical 

decisions about the use of a device or 

device type. However, two additional 

conditions exist that make use of this 

type of notification preferable: (1) 

CDRH’s understanding of the problem, 

its cause(s), and the scope of the risk; 

the Center believes that health care 

practitioners need the information they 

can provide, however incomplete, as 

soon as possible, and (2) the problem is 

actively being investigated by the 

Center, private industry, another 

Agency, or some other reliable entity, so 

that the Center expects to be able to 

update the PPHN when definitive new 

information becomes available. 

Notifications are sent to organizations 

affected by risks discussed in the 

notification, such as hospitals, nursing 

homes, hospices, home health care 

agencies, retail pharmacies, and other 

health care providers. Through a 

process for identifying and addressing 

postmarket safety issues related to 

regulated products, CDRH determines 

when to publish notifications. 

Section 1701(a)(4) of the Public 

Health Service Act (42 U.S.C. 

300u(a)(4)) authorizes FDA to conduct 

research relating to health information. 

FDA seeks to evaluate the clarity, 

timeliness, and impact of safety alerts 

and public health advisories by 

surveying a sample of recipients. 

Subjects will receive a questionnaire 

to be completed and returned to FDA. 

The information to be collected will 

address how clearly notifications for 

reducing risks are explained, the 

timeliness of the information, and 

whether the reader has taken any action 

to eliminate or reduce risks as a result 

of the information in the alert. Subjects 

will also be asked whether they wish to 

receive future notifications 

electronically, as well as how the PHN 

program might be improved. 

The information collected will be 

used to shape FDA’s editorial policy for 

the PHN and PPHN. Understanding how 

target audiences view these publications 

will aid in deciding what changes 

should be considered in their content 

and the format and method of 

dissemination. 

In the Federal Register of August 24, 

2009 (74 FR 42674), FDA published a 

60-day notice requesting comments. No 

comments were received. However, 

FDA is republishing this 30-day notice 

for public comment, due to the amount 

of time that has passed for submission 

of this information collection request to 

OMB. 

FDA estimates the burden of this 

collection of information as follows: 


hsrobinson on DSK69SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices 78257 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Public Health 

Service Act section 

Number of 

respondents 

Annual 

frequency 

per response 

Total annual 

responses 

Hours per 

response Total hours 

1701(a)(4) ............................................................................ 308 3 924 0.17 157 

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

Based on the history of the PHN 

program, it is estimated that an average 

of three collections will be conducted a 

year. The total burden of response time 

is estimated at 10 minutes per survey. 

This was derived by CDRH staff 

completing the survey and through 

discussions with the contacts in trade 

organizations. 

Dated: December 8, 2010. 

Leslie Kux, 

Acting Assistant, Commissioner for Policy. 

[FR Doc. 2010–31387 Filed 12–14–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0623] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Voluntary 

Cosmetic Registration Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the collection of information associated 

with the Agency’s Voluntary Cosmetic 

Registration Program (VCRP). 

DATES: Submit either electronic or 

written comments on the collection of 

information by February 14, 2011. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://www.regulations.

gov. Submit written comments on the 

collection of information to the Division 

of Dockets Management (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, rm. 1061, Rockville, MD 

20852. All comments should be 

identified with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850. 301–796– 

3793. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined in 

44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 

and includes Agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal Agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Voluntary Cosmetic Registration 

Program—21 CFR Parts 710 and 720 

(OMB Control Number 0910–0027)— 

Revision 

The Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) provides FDA with 

the authority to regulate cosmetic 

products in the United States. Cosmetic 

products that are adulterated under 

section 601 of the FD&C Act (21 U.S.C. 

361) or misbranded under section 602 of 

the FD&C Act (21 U.S.C. 362) may not 

be distributed in interstate commerce. 

To assist FDA in carrying out its 

responsibility to regulate cosmetics, the 

Agency has developed the VCRP. 

In 21 CFR part 710, FDA requests that 

establishments that manufacture or 

package cosmetic products register with 

the Agency on Form FDA 2511 entitled 

‘‘Registration of Cosmetic Product 

Establishment.’’ The term ‘‘Form FDA 

2511’’ refers to both the paper and 

electronic versions of the form. The 

electronic version of Form FDA 2511 is 

available on FDA’s VCRP Web site at 

http://www.fda.gov/Cosmetics/

GuidanceComplianceRegulatory

Information/VoluntaryCosmetics

RegistrationProgramVCRP/Online

Registration/default.htm. FDA’s online 

registration system, intended to make it 

easier to participate in the VCRP, was 

made available industrywide on 

December 1, 2005. The Agency strongly 

encourages electronic registration of 

Form FDA 2511 because it is faster and 

more convenient. A registering facility 

will receive confirmation of electronic 

registration, including a registration 

number, by e-mail, usually within 7 

business days. The online system also 

allows for amendments to past 

submissions. 

Because registration of cosmetic 

product establishments is not 

mandatory, voluntary registration 

provides FDA with the best information 

available about the locations, business 

trade names, and types of activity 

(manufacturing or packaging) of 

cosmetic product establishments. FDA 

places the registration information in a 

computer database and uses the 

information to generate mailing lists for 

distributing regulatory information and 

for inviting firms to participate in 

workshops on topics in which they may 

be interested. FDA also uses the 


hsrobinson on DSK69SOYB1PROD with NOTICES