9394 Federal Register / Vol. 78, No. 27 / Friday, February 8, 2013 / Notices 

Community as a Learning Health System. 

Committee members will consider ways to 

implement components of the graphic on the 

Influences on the Population’s Health, in the 

Shaping a Health Statistics Vision for the 

21st Century report. The Co-chairs for the 

Privacy, Confidentiality and Security 

Subcommittee will brief the Committee about 

an upcoming hearing to obtain input about 

implementing health data stewardship, and 

the Standards and Quality Subcommittees 

will also provide updates on plans and 

activities. 

On the morning of the second day, the 

Committee will continue to discuss ways to 

promote alignment throughout the 

Committee to enhance its effectiveness, focus 

on its themes, and utilize expertise of the 

NCVHS Working Group on HHS Data Access 

and Use. Once the full Committee adjourns, 

the NCVHS’s Working Group on HHS Data 

Access and Use will convene to discuss best 

practices and suggestions to further the 

dissemination and use of open HHS data, and 

summarize future plans of the Working 

Group. Further information will be provided 

on the NCVHS Web site at http:// 

www.ncvhs.hhs.gov/. 

The times shown above are for the full 

Committee meeting. Subcommittee breakout 

sessions are scheduled for late in the 

afternoon on the first day. Agendas for these 

breakout sessions will be posted on the 

NCVHS Web site (URL below) when 

available. 

Contact Person for More Information: 

Substantive program information as well as 

summaries of meetings and a roster of 

committee members may be obtained from 

Marjorie S. Greenberg, Executive Secretary, 

NCVHS, National Center for Health Statistics, 

Centers for Disease Control and Prevention, 

3311 Toledo Road, Room 2402, Hyattsville, 

Maryland 20782, telephone (301) 458–4245. 

Information also is available on the NCVHS 

home page of the HHS Web site: http:// 

www.ncvhs.hhs.gov/, where further 

information including an agenda will be 

posted when available. 

Should you require reasonable 

accommodation, please contact the CDC 

Office of Equal Employment Opportunity on 

(301) 458–4EEO (4336) as soon as possible. 

Dated: January 31, 2013. 

James Scanlon, 

Deputy Assistant Secretary for Planning and 

Evaluation, Office of the Assistant Secretary 

for Planning and Evaluation. 

[FR Doc. 2013–02830 Filed 2–7–13; 8:45 am] 

BILLING CODE 4151–05–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10419] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS) is publishing the 

following summary of proposed 

collections 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. 

1. Type of Information Collection 

Request: New collection (request for a 

new OMB control number). Title of 

Information Collection: Transparency 

Reports and Reporting of Physician 

Ownership or Investment Interests. Use: 

Reports of Payments or Other Transfers 

of Value to Covered Recipients. 

Section 403.904 requires direct and 

indirect payments or other transfers of 

value provided by an applicable 

manufacturer to a covered recipient, and 

that direct and indirect payments or 

other transfers of value provided to a 

third party at the request of (or 

designated by) the applicable 

manufacturer on behalf of a covered 

recipient, be reported by the applicable 

manufacturer to CMS on an annual 

basis. 

Reports of Physician Ownership and 

Investment Interests 

Under § 403.906, each applicable 

manufacturer and applicable group 

purchasing organization must report to 

CMS on an annual basis all ownership 

and investment interests in the 

applicable manufacturer or applicable 

group purchasing organization that were 

held by a physician or an immediate 

family member of a physician during 

the preceding calendar year. 

Data Collection 

The data templates will provide 

detailed information about the data to 

be collected including the data element 

name, format, allowable values, 

required versus optional fields, and 

other associated rules intended to aid 

the applicable manufacturers and 

applicable group purchasing 

organizations as they prepare for and 

participate in data collection. 

Applicable manufacturers and 

applicable GPOs will engage in data 

collection external to CMS within their 

own systems or tracking tools. If we 

intend to make changes to the data 

templates, we will provide them at least 

90 days prior to first day of data 

collection for the next reporting year. In 

providing revised templates, we will 

also comply with the requirements of 

the Paperwork Reduction Act to seek 

public comments on the proposed 

changes to the information collections, 

as required by law. This will allow 

applicable manufacturers and 

applicable GPOs to make any necessary 

changes to prepare for the next reporting 

year. This is the same time as the date 

by which we will publish the list of 

teaching hospitals. 

Data Submission Procedures for 

Electronic Submission of Reports 

Section 403.908 requires that reports 

must be electronically submitted to 

CMS by March 31, 2014, and by the 

90th day of each subsequent calendar 

year. Form Number: CMS–10461 (OCN 

0938—New). Frequency: Annual. 

Affected Public: Private Sector (business 

or other for-profit and not-for-profit 

institutions). Number of Respondents: 

396,514. Total Annual Responses: 

396,514. Total Annual Hours: 

13,327,065. (For policy questions 

regarding this collection contact Erica 

Breese at 202–260–6079. For all other 

issues call 410–786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or 

Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

In commenting on the proposed 

information collections please reference 

the document identifier or OMB control 

number. To be assured consideration, 

comments and recommendations must 

be submitted in one of the following 

ways by April 9, 2013: 


sroberts on DSK5SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 27 / Friday, February 8, 2013 / Notices 9395 

1. Electronically. You may submit 

your comments electronically to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) accepting comments. 

2. By regular mail. You may mail 

written comments to the following 

address: 

CMS, Office of Strategic Operations 

and Regulatory Affairs, Division of 

Regulations Development, Attention: 

Document Identifier/OMB Control 

Number _________, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: February 5, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–02905 Filed 2–7–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0560] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance on 

Informed Consent for In Vitro 

Diagnostic Device Studies Using 

Leftover Human Specimens That Are 

Not Individually Identifiable 

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 March 11, 

2013. 

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 0910–0582. 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. 

Guidance on Informed Consent for In 

Vitro Diagnostic Device Studies Using 

Leftover Human Specimens That Are 

Not Individually Identifiable—(OMB 

Control Number 0910–0582)—Extension 

FDA’s investigational device 

regulations are intended to encourage 

the development of new, useful devices 

in a manner that is consistent with 

public health, safety, and with ethical 

standards. Investigators should have 

freedom to pursue the least burdensome 

means of accomplishing this goal. 

However, to ensure that the balance is 

maintained between product 

development and the protection of 

public health, safety, and ethical 

standards, FDA has established human 

subject protection regulations 

addressing requirements for informed 

consent and institutional review board 

(IRB) review that apply to all FDAregulated clinical investigations 

involving human subjects. In particular, 

informed consent requirements further 

both safety and ethical considerations 

by allowing potential subjects to 

consider both the physical and privacy 

risks they face if they agree to 

participate in a trial. 

Under FDA regulations, clinical 

investigations using human specimens 

conducted in support of premarket 

submissions to FDA are considered 

human subject investigations (see 21 

CFR 812.3(p)). Many investigational 

device studies are exempt from most 

provisions of part 812, Investigational 

Device Exemptions, under 21 CFR 

812.2(c)(3), but FDA’s regulations for 

the protection of human subjects (21 

CFR parts 50 and 56) apply to all 

clinical investigations that are regulated 

by FDA (see 21 CFR 50.1, 21 CFR 

56.101, 21 U.S.C. 360j(g)(3)(A), and 21 

U.S.C. 360j(g)(3)(D)). 

FDA regulations do not contain 

exceptions from the requirements of 

informed consent on the grounds that 

the specimens are not identifiable or 

that they are remnants of human 

specimens collected for routine clinical 

care or analysis that would otherwise 

have been discarded. Nor do FDA 

regulations allow IRBs to decide 

whether or not to waive informed 

consent for research involving leftover 

or unidentifiable specimens. 

In a level 1 guidance document, 

entitled ‘‘Guidance on Informed 

Consent for In Vitro Diagnostic Device 

Studies Using Leftover Human 

Specimens That Are Not Individually 

Identifiable,’’ issued under the Good 

Guidances Practices regulation, 21 CFR 

10.115, FDA outlines the circumstances 

in which it intends to exercise 

enforcement discretion as to the 

informed consent regulations for 

clinical investigators, sponsors, and 

IRBs. 

The recommendations of the guidance 

impose a minimal burden on industry. 

FDA estimates that 700 studies will be 

affected annually. Each study will result 

in one annual record, estimated to take 

4 hours to complete. This results in a 

total recordkeeping burden of 2,800 

hours (700 × 4 = 2,800). 

In the Federal Register of June 12, 

2012 (77 FR 34954), 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 RECORDKEEPING BURDEN 1

Federal Food, Drug, and Cosmetic Act Section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

520(g) (21 U.S.C. 360j(g)) ................................................... 700 1 700 4 2,800 

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


sroberts on DSK5SPTVN1PROD with NOTICES