Federal Register / Vol. 76, No. 120 / Wednesday, June 22, 2011 / Notices 36539 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Assistant Secretary for 

Planning and Evaluation; Medicare 

Program; Meeting of the Technical 

Advisory Panel on Medicare Trustee 

Reports 

AGENCY: Assistant Secretary for 

Planning and Evaluation, HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces public 

meetings of the Technical Advisory 

Panel on Medicare Trustee Reports 

(Panel). Notice of these meetings is 

given under the Federal Advisory 

Committee Act (5 U.S.C. App. 2, section 

10(a)(1) and (a)(2)). The Panel will 

discuss the short-term (10 year) 

projection methods and assumptions in 

projecting Medicare health spending for 

Parts A, B, C and D and may make 

recommendations to the Medicare 

Trustees on how the Trustees might 

more accurately estimate health 

spending in the short run. The Panel’s 

discussion is expected to be very 

technical in nature and will focus on the 

actuarial and economic assumptions 

and methods by which Trustees might 

more accurately measure health 

spending. Although panelists are not 

limited in the topics they may discuss, 

the Panel is not expected to discuss or 

recommend changes in current or future 

Medicare provider payment rates or 

coverage policy. 

DATES: July 7, 2011, 9 a.m. to 5 p.m. 

ADDRESSES: The meeting will be held at 

HHS headquarters at 200 Independence 

Ave., SW., Washington, DC 20201, 

Room 738G. 

Comments: The meeting will allocate 

time on the agenda to hear public 

comments at the end of the meeting. In 

lieu of oral comments, formal written 

comments may be submitted for the 

record to Donald T. Oellerich, OASPE, 

200 Independence Ave., SW., 

Washington, DC 20201, Room 405F. 

Those submitting written comments 

should identify themselves and any 

relevant organizational affiliations. 

FOR FURTHER INFORMATION CONTACT: 

Donald T. Oellerich (202) 690–8410, 

Don.oellerich@hhs.gov. Note: Although 

the meeting is open to the public, 

procedures governing security 

procedures and the entrance to Federal 

buildings may change without notice. 

Those wishing to attend the meeting 

must call or e-mail Dr. Oellerich by 

Friday July 1, 2011, so that their name 

may be put on a list of expected 

attendees and forwarded to the security 

officers at HHS Headquarters. 

SUPPLEMENTARY INFORMATION: Topics of 

the Meeting: The Panel is specifically 

charged with discussing and possibly 

making recommendations to the 

Medicare Trustees on how the Trustees 

might more accurately estimate health 

spending in the United States. The 

discussion is expected to focus on 

highly technical aspects of estimation 

involving economics and actuarial 

science. Panelists are not restricted, 

however, in the topics that they choose 

to discuss. 

Procedure and Agenda: This meeting 

is open to the public. The Panel will 

likely hear presentations by panel 

members and HHS staff regarding short 

range projection methods and 

assumptions. After any presentations, 

the Panel will deliberate openly on the 

topic. Interested persons may observe 

the deliberations, but the Panel will not 

hear public comments during this time. 

The Panel will also allow an open 

public session for any attendee to 

address issues specific to the topic. 

Authority: 42 U.S.C. 217a; Section 222 of 

the Public Health Services Act, as amended. 

The panel is governed by provisions of 

Public Law 92–463, as amended (5 U.S.C. 

Appendix 2), which sets forth standards for 

the formation and use of advisory 

committees. 

Sherry Glied, 

Assistant Secretary for Planning and 

Evaluation. 

[FR Doc. 2011–15515 Filed 6–21–11; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Statement of Organization, Functions, 

and Delegations of Authority 

Part A, Office of the Secretary, 

Statement of Organization, Functions, 

and Delegations of Authority for the 

U.S. Department of Health and Human 

Services is being amended at Chapter 

AA, Immediate Office of the Secretary, 

as last amended at 76 FR 4703, dated, 

January 26, 2011, and at Chapter AQ, 

Office of Global Health Affairs (OGHA), 

as last amended at 69 FR 51679–80, 

dated August 20, 2004, as follows: 

I. Under Part A, Chapter AA, Section 

AA.10 Organization, replace ‘‘Office of 

Global Health Affairs (AQ)’’ with 

‘‘Office of Global Affairs (AQ).’’ 

II. Under Part A, Chapter AQ, replace 

all references to the ‘‘Office of Global 

Health Affairs’’ with ‘‘Office of Global 

Affairs’’ and all references to ‘‘OGHA’’ 

with ‘‘OGA.’’ 

III. Delegation of Authority. All 

delegations and redelegations of 

authority made to officials and 

employees of the Office of Global Affairs 

will continue in them or their 

successors pending further redelegation, 

provided they are consistent with this 

reorganization. 

Dated: June 14, 2011. 

E.J. Holland, Jr., 

Assistant Secretary for Administration. 

[FR Doc. 2011–15517 Filed 6–21–11; 8:45 am] 

BILLING CODE 4110–60–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Insulin Delivery and Glucose 

Monitoring Devices for Diabetes 

Mellitus 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Request for scientific 

information submissions. 

SUMMARY: The Agency for Healthcare 

Research and Quality (AHRQ) is seeking 

scientific information submissions from 

medical device manufacturers of insulin 

pumps and continuous glucose 

monitors. Scientific information is being 

solicited to inform our Comparative 

Effectiveness and Safety of Insulin 

Delivery and Glucose Monitoring 

Methods for Diabetes Mellitus review, 

which is currently being conducted by 

the Evidence-based Practice Centers for 

the AHRQ Effective Health Care 

Program. Access to published and 

unpublished pertinent scientific 

information on this device will improve 

the quality of this comparative 

effectiveness review. AHRQ is 

requesting this scientific information 

and conducting this comparative 

effectiveness review pursuant to Section 

1013 of the Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003, Public Law 108–173. 

DATES: Submission Deadline on or 

before July 22, 2011. 

ADDRESSES: Online submissions: http:// 

effectivehealthcare.AHRQ.gov/

index.cfm/submit-scientificinformation-packets/. Please select the 

study for which you are submitting 

information from the list of current 

studies and complete the form to upload 

your documents. 

E-mail submissions: ehcsrc@ohsu.edu. 

Print submissions: Robin Paynter, 

Oregon Health and Science University, 

Oregon Evidence-based Practice Center, 

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36540 Federal Register / Vol. 76, No. 120 / Wednesday, June 22, 2011 / Notices 

3181 SW Sam Jackson Park Road, Mail 

Code: BICC, Portland, OR 97239–3098. 

FOR FURTHER INFORMATION CONTACT: 

Robin Paynter, Research Librarian, 

Telephone: 503–494–0147 or E-mail: 

ehcsrc@ohsu.edu. 

SUPPLEMENTARY INFORMATION: In 

accordance with Section 1013 of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003, Public Law 108–173, the Agency 

for Healthcare Research and Quality has 

commissioned the Effective Health Care 

(EHC) Program Evidence-based Practice 

Centers to complete a comparative 

effectiveness review of the evidence for 

the Effectiveness and Safety of Insulin 

Delivery and Glucose Monitoring 

Methods for Diabetes Mellitus. 

The EHC Program is dedicated to 

identifying as many studies as possible 

that are relevant to the questions for 

each of its reviews. In order to do so, we 

are supplementing the usual manual 

and electronic database searches of the 

literature by systematically requesting 

information (e.g. details of studies 

conducted) from medical device 

industry stakeholders through public 

information requests, including via the 

Federal Register and direct postal and/ 

or online solicitations. We are looking 

for studies that report on the 

Comparative Effectiveness and Safety of 

Insulin Delivery and Glucose 

Monitoring Methods for Diabetes 

Mellitus, including those that describe 

adverse events, as specified in the key 

questions detailed below. The entire 

research protocol, including the key 

questions, is also available online at: 

http://effectivehealthcare.AHRQ.gov/

index.cfm/search-for-guides-reviewsand-reports/?PAGEaction=

displayproduct&productid=689. 

This notice is a request for industry 

stakeholders to submit the following: 

• A current product label, if 

applicable (preferably an electronic PDF 

file). 

• Information identifying published 

randomized controlled trials and 

observational studies relevant to the 

clinical outcomes. Please provide both a 

list of citations and reprints if possible. 

• Information identifying 

unpublished randomized controlled 

trials and observational studies relevant 

to the clinical outcomes. If possible, 

please provide a summary that includes 

the following elements: Study number, 

study period, design, methodology, 

indication and diagnosis, proper use 

instructions, inclusion and exclusion 

criteria, primary and secondary 

outcomes, baseline characteristics, 

number of patients screened/eligible/ 

enrolled/lost to withdrawn/follow-up/ 

analyzed, and effectiveness/efficacy and 

safety results. Registered 

ClinicalTrials.gov studies. Please 

provide a list including the 

ClinicalTrials.gov identifier, condition, 

and intervention. 

Your contribution is very beneficial to 

this program. AHRQ is not requesting 

and will not consider marketing 

material, health economics information, 

or information on other indications. 

This is a voluntary request for 

information, and all costs for complying 

with this request must be borne by the 

submitter. 

Please Note: The contents of all 

submissions, regardless of format, will 

be available to the public upon request 

unless prohibited by law. 

The draft of this review will be posted 

on AHRQ’s EHC program website and 

available for public comment for a 

period of 4 weeks. If you would like to 

be notified when the draft is posted, 

please sign up for the e-mail list at: 

http://effectivehealthcare.AHRQ.gov/

index.cfm/join-the-email-list1/. 

Key Questions 

Our draft Key Questions (KQs) were 

posted for public comment in October 

2010 (see Appendix 1). Based on the 

public comments, we made the 

following changes to the KQs: 

1. We will not include pregnant 

women with gestational diabetes in the 

review. There is a range of glucose 

abnormalities among women with 

gestational diabetes, and many women 

with gestational diabetes are not on 

intensive insulin therapy. Insulin pump 

therapy and CGM are more relevant to 

pregnant women with pre-existing 

diabetes. The population for this review 

will include patients with type 1 

diabetes, patients with type 2 diabetes 

who are on insulin therapy, and 

pregnant women with pre-existing 

diabetes. 

2. We will see if there are any studies 

that focused on older adults (age >65 

years). Currently, there is no upper age 

limit on our proposed study 

populations, so we should be able to 

examine this group if data are available. 

Therefore, the age categories considered 

for this review will be very young 

children, adolescents and adults, 

including older adults (age >65 years). 

3. KQ3 was made a subquestion of 

KQ 2. 

There were several other relevant 

comments about the KQs and the 

protocol. These comments and our 

responses are summarized below. 

1. We plan to abstract the following 

data to use in our analysis when 

available: measurement of adherence, 

MDI delivery method (pen vs. vial or 

syringe), study design, information 

about device use (e.g., analyses based on 

adherence to wearing the device, 

training of patient/staff, generation/ 

model of devices), study participant 

characteristics, adjustment to insulin 

therapy, definitions of hypoglycemia, 

definitions of diabetes, assessment of 

quality of life, rt-CGM alarm threshold, 

and study length and followup time. 

2. Because insulin regimens may 

change over time, it may be difficult to 

determine if the current delivery 

method is responsible for the long-term 

outcomes. Therefore, we will abstract 

data on the length of use of current 

technology, changes in the mode of 

insulin delivery over time, and changes 

in the type of insulin used over time if 

available. 

3. The list of process measures and 

intermediate outcomes will not change. 

Some of the suggested outcomes were 

either beyond the scope of the review 

(e.g., changes in carbohydrate counting, 

diet, and physical activity) or only 

applied to a particular insulin-delivery 

device or blood glucose-monitoring 

technique (e.g., time spent in the 

hypoglycemic range). 

The finalized KQs are: 

KQ 1 

In patients receiving intensive insulin 

therapy, does mode of delivery 

(multiple daily injections [MDI] vs. 

continuous subcutaneous insulin 

infusion [CSII]) have a differential effect 

on process measures, intermediate 

outcomes, and clinical outcomes in 

patients with diabetes mellitus? (Process 

measures, intermediate outcomes, and 

clinical outcomes of interest are 

summarized below in Table 1.) Do these 

effects differ by: 

a. Type 1 or type 2 diabetes status? 

b. Age: Very young children, 

adolescents, and adults, including older 

adults (age >65 years)? 

c. Pregnancy status: Pre-existing type 

1 or type 2 diabetes? 

KQ 2 

In patients using intensive insulin 

therapy (MDI or CSII), does the type of 

glucose monitoring (real-time 

continuous glucose monitoring [rt-CGM] 

vs. self-monitoring of blood glucose 

[SMBG]) have a differential effect on 

process measures, intermediate 

outcomes, and clinical outcomes (see 

Table 1) in patients with diabetes 

mellitus (i.e., what is the incremental 

benefit of rt-CGM in patients already 

using intensive insulin therapy on 

process and outcome measures)? Do 

these effects differ by: 

a. Type 1 or type 2 diabetes status? 

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Federal Register / Vol. 76, No. 120 / Wednesday, June 22, 2011 / Notices 36541 

b. Age: Very young children, 

adolescents, and adults, including older 

adults (age >65 years)? 

c. Pregnancy status: Pre-existing type 

1 or type 2 diabetes? 

d. Intensive insulin delivery: MDI or 

CSII? 

TABLE 1—SUMMARY OF PROCESS MEASURES AND INTERMEDIATE AND CLINICAL OUTCOMES

Process measures Intermediate outcomes Clinical outcomes 

• Ratio of basal to bolus insulin ........................

• Frequency of adjusting insulin therapy ..........

• Adherence to insulin therapy/sensor use .......

• Frequency of professional or allied health 

visits.

• Primary 

• Hemoglobin A1c

• Secondary 

• Hyperglycemia 

• Weight gain 

• Hypoglycemia frequency 

• Microvascular* 

• Retinopathy 

• Nephropathy 

• Neuropathy 

• Macrovascular* 

• Coronary heart disease 

• Cerebrovascular disease 

• Peropheral arterial disease 

• Severe hypoglycemia 

• Quality of life 

• Fetal outcomes †

• Maternal pregnancy outcomes 

• C-section rates 

* We will only include objective assessments of microvascular and macrovascular outcomes (i.e., we will be excluding patient self-reported 

microvascular and macrovascular outcomes). †Fetal outcomes include gestational age, birth weight, frequency of neonatal hypoglycemia, birth trauma, major and minor anomalies, and admission to a neonatal intensive care unit. 

For each KQ we will identify: 

Population(s): 

Adults, adolescents, and children 

with type 1 or type 2 diabetes mellitus 

and pregnant women with pre-existing 

diabetes treated with insulin therapy. 

1. We will use age ranges prescribed 

by the Juvenile Diabetes Research 

Foundation (<8 years [very young 

children], 8–14 years [children], 14–25 

years [adolescent], and >25 years 

[adults]); however, our final definitions 

will be guided by those used in the 

literature that is reviewed. 

2. If available, we will examine data 

among populations of older adult (>65 

years). 

Interventions: 

The interventions of interest are CSII 

(see Appendix 2 for a list of insulin 

pumps and models) and rt-CGM (see 

Appendix 3 for a list of monitors). 

1. We will not be including the 

following devices because they are no 

longer used in the United States: 

a. GlucoWatch continuous glucose 

meter 

b. Insulin pumps with regular insulin 

Comparators: 

All studies must have a concurrent 

comparison group. 

1. CSII would be compared with MDI, 

which will be defined as at least three 

injections of basal and rapid-acting 

insulin per day. 

2. rt-CGM would be compared with 

SMBG, which will be defined as at least 

three fingersticks per day. 

Outcomes measures for each KQ: 

1. Process measures 

a. Ratio of basal to bolus insulin 

b. Frequency of adjustments to insulin 

therapy 

c. Adherence to insulin therapy/sensor 

use 

d. Frequency of professional or allied 

health visits Intermediate outcomes 

• HbA1c 

a. Hyperglycemia 

b. Weight gain 

c. Hypoglycemia frequency 

Clinical Outcomes 

• Objective assessments of 

microvascular outcomes (retinopathy, 

nephropathy, and neuropathy) 

a. Objective assessments of 

macrovascular outcomes (coronary 

heart disease, cerebrovascular disease, 

and peripheral arterial disease) 

b. Severe hypoglycemia 

c. Quality of life 

d. Fetal outcomes (gestational age, birth 

weight, frequency of neonatal 

hypoglycemia, birth trauma, major 

and minor anomalies, and admission 

to a neonatal intensive care unit) 

e. Maternal pregnancy outcomes 

(cesarean section rates) 

Timing: Usage of a device for at least 

24 hours. 

Settings: Outpatient setting. 

Dated: June 10, 2011. 

Carolyn M. Clancy, 

AHRQ, Director. 

[FR Doc. 2011–15580 Filed 6–21–11; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0110] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Prescription Drug Advertisements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Prescription Drug Advertisements’’ has 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

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 the 

Federal Register of January 24, 2011 (76 

FR 4117), the Agency announced that 

the proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0686. The 

approval expires on June 30, 2014. A 

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