27346 Federal Register / Vol. 75, No. 93 / Friday, May 14, 2010 / Notices 

ANNUAL ESTIMATED BURDEN HOURS

Type of respondent Number of 

respondents 

Number of 

responses/ 

respondent 

Average 

burden 

hours per 

response 

Total 

burden 

hours 

Hospital staff (Training) ................................................................................................... 6,000 1 1 6,000 

Hospital staff (data collection) ......................................................................................... 6,000 102 1 612,000 

State/Territory Preparedness staff (training) ................................................................... 62 1 1 62 

State/Territory Preparedness staff (data collection) ........................................................ 62 102 3 18,972 

Total .......................................................................................................................... .................... .................... .................... 31,154 

Seleda Perryman, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer. 

[FR Doc. 2010–11567 Filed 5–13–10; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–NEW; 30- 

day notice] 

Agency Information Collection 

Request. 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Office of the Secretary (OS), Department 

of Health and Human Services, is 

publishing the following summary of a 

proposed collection for public 

comment. Interested persons are invited 

to send comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, e-mail your request, 

including your address, phone number, 

OMB number, and OS document 

identifier, to 

Sherette.funncoleman@hhs.gov, or call 

the Reports Clearance Office on (202) 

690–5683. Send written comments and 

recommendations for the proposed 

information collections within 30 days 

of this notice directly to the OS OMB 

Desk Officer; faxed to OMB at 202–395– 

5806. 

Proposed Project: Evaluation of 

Medicare Personal Health Records 

Choice Pilot—OMB No. 0990–NEW— 

Office of the Assistant Secretary for 

Planning and Evaluation. 

Abstract: Since 2003, HHS has 

worked toward the goal of establishing 

electronic, longitudinal health records 

for Americans that can be accessed 

safely, across the internet, and anytime 

and anywhere by patients, doctors, and 

other health care providers. In addition 

to electronic health records (EHRs), 

where health information is created, 

stored and accessed mainly by health 

care organizations and practitioners, 

personal health records (PHRs), 

electronic, patient-centered applications 

and services, are gaining increasing 

recognition and momentum. Current 

PHR business models represent broad 

and varied uses, from disease 

management to health promotion, with 

sponsors consisting of commercial 

vendors, heath plans, employers, and 

health care providers. We know very 

little about why consumers, and 

specifically Medicare beneficiaries, elect 

to use PHRs and what functionality they 

want from a PHR. Understanding these 

needs will be critical if HHS and the 

Centers for Medicare & Medicaid 

Services (CMS) are to pursue PHRs as a 

tool to empower consumers to manage 

their health and have the capability to 

link to their provider’s EHR. 

In January 2009, CMS launched a new 

program in Arizona and Utah, the 

Medicare PHR Choice Pilot (PHRC). 

This pilot encourages Medicare fee-forservice (FFS) beneficiaries to take 

advantage of the newer, more robust 

Internet-based tools for tracking their 

health and health care services. This is 

the first pilot to offer a choice of PHRs 

to Medicare FFS beneficiaries, including 

PHRs with additional functionality and 

direct data linkages for the consumers. 

Pilot participants can choose among 

GoogleHealthTM, NoMoreClipboardTM, 

PassportMDTM, and HealthTrioTM, 

competitors in the open PHR market. 

HHS’ Office of the Assistant Secretary 

for Planning and Evaluation (ASPE) has 

contracted with Mathematica Policy 

Research to conduct an evaluation of 

this pilot program, including a PHR 

enrollee user satisfaction survey to 

assess barriers, facilitators, and 

satisfaction with the PHRs. A selfadministered paper-and-pencil 

instrument will be the primary data 

collection mode for the PHRC user 

satisfaction survey, with telephone 

followup for mail nonrespondents. The 

one-time data collection field period is 

expected to be 12 weeks in Fall 2010. 

ESTIMATED ANNUALIZED BURDEN TABLE

Forms 

(if necessary) Type of respondent Number of respondents 

Number of responses per 

respondent 

Average burden hours per 

response 

Total burden 

hours 

Self-administered questionnaire ....... Medicare beneficiaries ..................... 500 1 25/60 208 

Total ........................................... ........................................................... 500 ........................ ........................ 208 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 93 / Friday, May 14, 2010 / Notices 27347 

Seleda Perryman, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer. 

[FR Doc. 2010–11568 Filed 5–13–10; 8:45 am] 

BILLING CODE 4150–05–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0545] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Biological 

Products: Reporting of Biological 

Product Deviations and Human Cells, 

Tissues, and Cellular and TissueBased Product Deviations in 

Manufacturing; Form FDA 3486 and 

Addendum 3486A 

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 June 14, 

2010. 

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 0910–0458. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–3792, 

Elizabeth.Berbakos@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. 

Biological Products: Reporting of 

Biological Product Deviations and 

Human Cells, Tissues, and Cellular and 

Tissue-Based Product Deviations in 

Manufacturing; Form FDA 3486 and 

Addendum 3486A—(OMB Control 

Number 0910–0458)—Extension 

Under section 351 of the Public 

Health Service Act (PHS Act) (42 U.S.C. 

262), all biological products, including 

human blood and blood components, 

offered for sale in interstate commerce 

must be licensed and meet standards, 

including those prescribed in the FDA 

regulations, designed to ensure the 

continued safety, purity, and potency of 

such products. In addition under 

section 361 of the PHS Act (42 U.S.C. 

264), FDA may issue and enforce 

regulations necessary to prevent the 

introduction, transmission, or spread of 

communicable diseases between the 

States or possessions or from foreign 

countries into the States or possessions. 

Further, the Federal Food, Drug, and 

Cosmetic Act (the act) (21 U.S.C. 351) 

provides that drugs and devices 

(including human blood and blood 

components) are adulterated if they do 

not conform with current good 

manufacturing practice (CGMP) assuring 

that they meet the requirements of the 

act. Establishments manufacturing 

biological products including human 

blood and blood components must 

comply with the applicable CGMP 

regulations (parts 211, 606, and 820 (21 

CFR parts 211, 606, and 820)) and 

current good tissue practice (CGTP) 

regulations (part 1271 (21 CFR part 

1271)) as appropriate. FDA regards 

biological product deviation (BPD) 

reporting and human cells, tissues, and 

cellular and tissue-based product (HCT/ 

P) deviation reporting to be an essential 

tool in its directive to protect public 

health by establishing and maintaining 

surveillance programs that provide 

timely and useful information. 

Section 600.14, in brief, requires the 

manufacturer who holds the biological 

product license, for other than human 

blood and blood components, and who 

had control over a distributed product 

when the deviation occurred, to report 

to the Center for Biologics Evaluation 

and Research (CBER) or to the Center for 

Drugs Evaluation and Research (CDER) 

as soon as possible but not to exceed 45 

calendar days after acquiring 

information reasonably suggesting that a 

reportable event has occurred. Section 

606.171, in brief, requires a licensed 

manufacturer of human blood and blood 

components, including Source Plasma; 

an unlicensed registered blood 

establishment; or a transfusion service 

who had control over a distributed 

product when the deviation occurred, to 

report to CBER as soon as possible but 

not to exceed 45 calendar days after 

acquiring information reasonably 

suggesting that a reportable event has 

occurred. Similarly, § 1271.350(b), in 

brief, requires non-reproductive HCT/P 

establishments described in § 1271.10 to 

report to CBER all HCT/P deviations 

relating to a distributed HCT/P that 

relates to the core CGTP requirements, 

if the deviation occurred in the 

establishment’s facility or in a facility 

that performed a manufacturing step for 

the establishment under contract, 

agreement or other arrangement. Form 

FDA 3486 is used to submit BPD reports 

and HCT/P deviation reports. 

Respondents to this collection of 

information are the licensed 

manufacturers of biological products 

other than human blood and blood 

components, licensed manufacturers of 

blood and blood components including 

Source Plasma, unlicensed registered 

blood establishments, transfusion 

services, and establishments that 

manufacture non-reproductive HCT/Ps 

regulated solely under section 361 of the 

PHS Act as described in § 1271.10. The 

number of respondents and total annual 

responses are based on the BPD reports 

and HCT/P deviation reports FDA 

received in fiscal year (FY) 2008. The 

number of licensed manufacturers and 

total annual responses under 21 CFR 

600.14 include the estimates for BPD 

reports submitted to both CBER and 

CDER. Based on the information from 

industry, the estimated average time to 

complete a deviation report is 2 hours. 

The availability of the standardized 

report form, Form FDA 3486, and the 

ability to submit this report 

electronically to CBER (CDER does not 

currently accept electronic filings) 

further streamlines the report 

submission process. 

CBER has developed an addendum to 

Form FDA 3486. The Web-based 

addendum 3486A provides additional 

information when a BPD report has been 

reviewed by FDA and evaluated as a 

possible recall. The additional 

information requested includes 

information not contained in the Form 

FDA 3486 such as: (1) Distribution 

pattern, (2) method of consignee 

notification, (3) consignee(s) of products 

for further manufacture, (4) additional 

product information, (5) updated 

product disposition, and (6) industry 

recall contacts. This information is 

requested by CBER through e-mail 

notification to the submitter of the BPD 

report. This information is used by 

CBER for recall classification purposes. 

At this time Addendum 3486A is being 

used only for those BPD reports 


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