65410 Federal Register / Vol. 79, No. 213 / Tuesday, November 4, 2014 / Notices 

there is adequate publicly available and 

widely established evidence supporting 

the claim, then the time to gather 

supporting data will be minimal; if the 

product is the first of its kind to make 

a particular claim or the evidence 

supporting the claim is less publicly 

available or not widely established, then 

gathering the appropriate scientific 

evidence to substantiate the claim will 

be more time consuming. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Claim type Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Widely known, established .................................................. 667 1 667 44 29,348 

Pre-existing, not widely established .................................... 667 1 667 120 80,040 

Novel .................................................................................... 667 1 667 120 80,040 

Total .............................................................................. ........................ ........................ ........................ ........................ 189,428 

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

We assume that it will take 44 hours 

to assemble information needed to 

substantiate a claim on a particular 

dietary supplement when the claim is 

widely known and established. We 

believe it will take closer to 120 hours 

to assemble supporting scientific 

information when the claim is novel or 

when the claim is pre-existing but the 

scientific underpinnings of the claim are 

not widely established. These are claims 

that may be based on emerging science, 

where conducting literature searches 

and understanding the literature takes 

time. It is also possible that references 

for claims made for some dietary 

ingredients or dietary supplements may 

primarily be found in foreign journals 

and in foreign languages or in the older, 

classical literature where it is not 

available on computerized literature 

databases or in the major scientific 

reference databases, such as the 

National Library of Medicine’s literature 

database, all of which increases the time 

of obtaining substantiation. 

In the Federal Register of January 6, 

2000 (65 FR 1000), we published a final 

rule on statements made for dietary 

supplements concerning the effect of the 

product on the structure or function of 

the body. In that final rule, we estimated 

that there were 29,000 dietary 

supplement products marketed in the 

United States (65 FR 1000 at 1045). 

Assuming that the flow of new products 

is 10 percent per year, then 2,900 new 

dietary supplement products will come 

on the market each year. The structure/ 

function final rule estimated that about 

69 percent of dietary supplements have 

a claim on their labels, most probably a 

structure/function claim (65 FR 1000 at 

1046). Therefore, we assume that 

supplement manufacturers will need 

time to assemble the evidence to 

substantiate each of the 2,001 claims 

(2,900 × 69 percent) made each year. If 

we assume that the 2,001 claims are 

equally likely to be pre-existing widely 

established claims, novel claims, or preexisting claims that are not widely 

established, then we can expect 667 of 

each of these types of claims to be 

substantiated per year. Table 1 of this 

document shows that the annual burden 

hours associated with assembling 

evidence for claims is 189,428 (the sum 

of 667 × 44 hours, 667 × 120 hours, and 

667 × 120 hours). 

Dated: October 28, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–26142 Filed 11–3–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1698] 

Food and Drug Administration 

Activities for Patient Participation in 

Medical Product Discussions; 

Establishment of a Public Docket 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; Establishment of docket; 

Request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

establishment of a public docket for 

comments on FDA activities performed 

under the Food and Drug 

Administration Safety and Innovation 

Act (FDASIA), Patient Participation in 

Medical Product Discussions. This 

notice announces FDA’s intent to gather 

input from stakeholders on strategies to 

obtain the views of patients during the 

medical product development process 

and ways to consider patients’ 

perspectives during regulatory 

discussions. This notice provides 

background on ongoing patient 

engagement activities, so that 

stakeholders can consider both current 

and new activities that involve patient 

participation and perspectives during 

medical product regulatory discussions. 

DATES: Although FDA welcomes 

comments at any time, to help FDA 

address issues related to Patient 

Participation in Medical Products 

Discussions in a timely fashion, 

comments should be submitted by 

December 4, 2014. 

ADDRESSES: Submit electronic 

comments to http://

www.regulations.gov. Submit written 

comments 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: 

Andrea Furia-Helms, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5319, Silver Spring, 

MD 20993–0002, Andrea.Furia@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On July 9, 2012, the President signed 

into law FDASIA (Pub. L. 112–144). 

FDASIA expands the FDA’s authorities 

and strengthens the Agency’s ability to 

safeguard and advance public health in 

several areas including increasing 

stakeholder involvement in FDA 

regulatory processes. Specifically, 

section 1137 of FDASIA directs the 

Secretary of HHS to ‘‘develop and 

implement strategies to solicit the views 

of patients during the medical product 

development process and consider the 

perspectives of patients during 

regulatory discussions, including by— 

(1) fostering participation of a patient 

representative who may serve as a 

special government employee in 


rmajette on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 213 / Tuesday, November 4, 2014 / Notices 65411 

appropriate agency meetings with 

medical product sponsors and 

investigators; and (2) exploring means to 

provide for identification of patient 

representatives who do not have any, or 

have minimal, financial interests in the 

medical products industry.’’ 

FDA has formed an Agency-wide 

working group to explore approaches 

and procedures as well as to align 

strategies across the Agency for patient 

participation in accordance with the 

statute. Involvement of the patient 

community brings the unique 

perspective of patients, family members, 

caregivers, and patient advocates to the 

decision-making processes of the FDA, 

and FDA is currently using a variety of 

tools to help ensure that the patient 

community is involved in medical 

product discussions to enhance benefitrisk assessment. FDA assesses the 

benefit-risk of new drugs and certain 

devices on a case-by-case basis. In this 

assessment, FDA may consider, among 

other things, the degree of unmet 

medical need and the severity and 

morbidity of the condition or disease 

the drug or device is intended to treat 

or diagnose. This approach has been 

critical to increasing patient access to 

new treatments for cancer, other serious 

diseases, and rare diseases, where 

existing therapies have been few and 

limited in their effectiveness. 

Currently, patient representatives can 

serve as Special Government Employees 

(SGEs) in order to participate as a 

member of an FDA’s federal advisory 

committee meeting about medical 

products undergoing the FDA review 

process for marketing approval and 

other regulatory issues. Patient 

representatives serve as committee 

members on advisory committees 

managed by the Office of the 

Commissioner, Center for Drug 

Evaluation and Research, Center for 

Biologics Evaluation and Research, and 

Center for Devices and Radiological 

Health. SGE patient representatives may 

also serve on special assignments to 

provide feedback and perspective on 

product reviews in progress. These SGE 

activities are in addition to the many 

other activities in which FDA obtains 

patient perspectives, such as open 

public hearings on specific diseases or 

drug development issues, and as 

speakers at FDA-sponsored conferences 

and workshops. 

FDASIA includes the reauthorization 

of the Prescription Drug User Fee Act 

(PDUFA) that provides FDA with the 

necessary resources to maintain a 

predictable and efficient review process 

for human drug and biological products. 

This is the fifth authorization of PDUFA 

(otherwise known as ‘‘PDUFA V’’), 

which was, as directed by Congress, 

developed in consultation with drug 

industry representatives, patient and 

consumer advocates, health care 

professionals, and other public 

stakeholders. Under PDUFA V, FDA 

intends to conduct at least 20 public 

meetings that aim to more 

systematically gather patients’ 

perspectives on their conditions and 

available therapies to treat those 

conditions (Patient Focused Drug 

Development). PDUFA V also includes 

an initiative to enhance FDA’s review of 

patient-reported outcome study 

endpoints and endpoint assessment 

tools. 

FDASIA also includes the 

reauthorization of the Medical Device 

User Fee Act (MDUFA) that provides 

FDA the necessary resources to increase 

the efficiency of regulatory processes in 

order to reduce the time it takes to bring 

safe and effective medical devices to the 

U.S. market. This third authorization of 

MDUFA (otherwise known as ‘‘MDUFA 

III’’), was a result of more than a year 

of public input, negotiations with 

industry representatives, and 

discussions with patient and consumer 

stakeholders. Under MDUFA III, FDA 

has established the Patient Preference 

Initiative to provide the information, 

guidance, and framework necessary to 

incorporate patient preferences on the 

benefit-risk tradeoffs of medical devices 

into the full spectrum of medical device 

regulatory processes and to inform 

medical device innovation by the larger 

medical device community. In the 

process, the initiative aims to advance 

the science of measuring medical device 

preferences of patients, caregivers, and 

providers. Once the Patient Preference 

Initiative helps to define or refine the 

methods to measure patient preferences, 

FDA intends to incorporate patient 

views into the total product life cycle of 

medical devices. 

FDA is opening a docket for 30 days 

to provide an opportunity for interested 

stakeholders to submit comments on 

‘‘strategies to solicit the views of 

patients during the medical product 

development process and consider the 

perspectives of patients during 

regulatory discussions’’ under section 

1137 of FDASIA. FDA is interested in 

comments on both current and new 

activities that would involve patient 

participation in regulatory discussions, 

as well as comments on ways to assess 

patient participation activities. 

II. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

Dated: October 29, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–26145 Filed 11–3–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Current List of HHS-Certified 

Laboratories and Instrumented Initial 

Testing Facilities Which Meet Minimum 

Standards To Engage in Urine Drug 

Testing for Federal Agencies 

AGENCY: Substance Abuse and Mental 

Health Services Administration, HHS. 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services (HHS) notifies federal 

agencies of the laboratories and 

Instrumented Initial Testing Facilities 

(IITF) currently certified to meet the 

standards of the Mandatory Guidelines 

for Federal Workplace Drug Testing 

Programs (Mandatory Guidelines). The 

Mandatory Guidelines were first 

published in the Federal Register on 

April 11, 1988 (53 FR 11970), and 

subsequently revised in the Federal 

Register on June 9, 1994 (59 FR 29908); 

September 30, 1997 (62 FR 51118); 

April 13, 2004 (69 FR 19644); November 

25, 2008 (73 FR 71858); December 10, 

2008 (73 FR 75122); and on April 30, 

2010 (75 FR 22809). 

A notice listing all currently HHScertified laboratories and IITFs is 

published in the Federal Register 

during the first week of each month. If 

any laboratory or IITF certification is 

suspended or revoked, the laboratory or 

IITF will be omitted from subsequent 

lists until such time as it is restored to 

full certification under the Mandatory 

Guidelines. 

If any laboratory or IITF has 

withdrawn from the HHS National 

Laboratory Certification Program (NLCP) 

during the past month, it will be listed 

at the end and will be omitted from the 

monthly listing thereafter. 


rmajette on DSK3VPTVN1PROD with NOTICES