7610 Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Recall Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Firm Initiated Recall (21 CFR 7.46) and Recall Communications (21 CFR 7.49) ................................................... 3,801 1 3,801 25 95,025 

Recall Status Reports (21 CFR 7.53) .................................. 3,801 13 49,413 10 494,130 

Termination of a Recall (21 CFR 7.55(b)) ........................... 3,801 1 3,801 10 38,010 

Total .............................................................................. ........................ ........................ ........................ ........................ 627,165 

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

I. Total Annual Reporting 

A. Firm Initiated Recall and Recall 

Communications 

Request firms voluntarily remove or 

correct foods and drugs (human or 

animal), cosmetics, medical devices, 

biologics, and tobacco to immediately 

notify the appropriate FDA District 

Office of such actions. The firm is to 

provide complete details of the recall 

reason, risk evaluation, quantity 

produced, distribution information, 

firms’ recall strategy and a contact 

official as well as requires firms to 

notify their direct accounts of the recall 

and to provide recipients with a ready 

means of reporting to the recalling firm. 

Under these portions of the collection of 

information, the Agency estimates it 

will receive 3,801 responses annually 

based on the average number of recalls 

over the last 3 fiscal years. The number 

of responses multiplied by the number 

of respondents equal 3,801. The average 

burden hours of 25 multiplied by the 

total number of annual responses equal 

95,025. The average burden hour person 

response was 30 and has decreased by 

5. 

B. Recall Status Reports 

Request that recalling firms provide 

periodic status reports so FDA can 

ascertain the progress of the recall. This 

request only applies to firms with active 

recalls, and is estimated to be reported 

every 2 to 4 weeks. This collection of 

information will generate approximately 

3,801 responses annually, based on the 

average number of recalls over the last 

3 fiscal years (11,403). The number of 

respondents multiplied by the number 

of responses per respondents (13) equal 

a total number of annual responses of 

49,413. The total number of responses 

49,413 with an average burden hours of 

10 per response equal a total of 494,130 

total hours. 

C. Termination of a Recall 

Provide the firms an opportunity to 

request in writing that FDA end the 

recall. The Agency estimates it will 

receive 3,801 responses annually based 

on the average number of terminations 

over the past 3 fiscal years. The total 

annual responses of 3,801 multiplied by 

the average burden hours of 10 per 

response equal a total number of hours 

of 38,010. 

II. Total Annual Third-Party Disclosure 

Burden 

Recall Communications. Request 

firms to notify their consignees of the 

recall and to provide recipients with a 

ready means of reporting to the recalling 

firm. Under this portion of the 

collection of information, the Agency 

estimates firms will provide 1,691,445 

notifications annually based on the 

number of respondents/consignees 

(3,807) multiplied by the number of 

disclosures per respondent (445). The 

total number of hours is 94,721 (based 

on 1,691,445 multiplied by 0.056 

hours). 

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN

21 CFR Part Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Recall Communications (21 CFR 7.49) ..................... 3,801 445 1,691,445 0.056 (3 minutes) 94,721 

FDA regulates many different types of 

products including, but not limited to, 

medical products, food and feed, 

cosmetics, and tobacco products. FDA 

notes that not all third-party disclosures 

provided by firms to their consignees 

are similar in nature and may entail 

different methods and mediums of 

communication. FDA estimates the 

burden for third-party disclosure per 

recall event to be an average of 25 hours. 

This burden estimate factored out to the 

average number of consignees per recall 

(445) results in a burden per disclosure 

estimate of approximate hours (25 hours 

per recall/445 disclosures/recall = 0.056 

hours). 

Dated: February 5, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–02788 Filed 2–10–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0403] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Substantiation for 

Dietary Supplement Claims Made 

Under the Federal Food, Drug, and 

Cosmetic Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices 7611 

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 13, 

2015. 

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 0910–0626. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Road; COLE–14526, Silver 

Spring, MD 20993–0002 PRAStaff@

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. 

Substantiation for Dietary Supplement 

Claims Made Under the Federal Food, 

Drug, and Cosmetic Act—21 U.S.C. 

343(r)(6) (OMB Control Number 0910– 

0626)—Extension 

Section 403(r)(6) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 343(r)(6)) requires that a 

manufacturer of a dietary supplement 

making a nutritional deficiency, 

structure/function, or general well-being 

claim have substantiation that the claim 

is truthful and not misleading. Under 

section 403(r)(6)(A) of the FD&C Act, 

such a statement is one that ‘‘claims a 

benefit related to a classical nutrient 

deficiency disease and discloses the 

prevalence of such disease in the United 

States, describes the role of a nutrient or 

dietary ingredient intended to affect the 

structure or function in humans, 

characterizes the documented 

mechanism by which a nutrient or 

dietary ingredient acts to maintain such 

structure or function, or describes 

general well-being from consumption 

for a nutrient or dietary ingredient.’’ 

The guidance document, entitled 

‘‘Substantiation for Dietary Supplement 

Claims Made Under Section 403(r)(6) of 

the Federal Food, Drug, and Cosmetic 

Act,’’ provides our recommendations to 

manufacturers about the amount, type, 

and quality of evidence they should 

have to substantiate a claim under 

section 403(r)(6) of the FD&C Act. The 

guidance does not discuss the types of 

claims that can be made concerning the 

effect of a dietary supplement on the 

structure or function of the body, nor 

does it discuss criteria to determine 

when a statement about a dietary 

supplement is a disease claim. The 

guidance document is intended to assist 

manufacturers in their efforts to comply 

with section 403(r)(6) of the FD&C Act. 

Persons with access to the Internet may 

obtain the guidance at http://

www.fda.gov/FoodGuidances. 

Dietary supplement manufacturers 

collect the necessary substantiating 

information for their product as 

required by section 403(r)(6) of the 

FD&C Act. The guidance provides 

information to manufacturers to assist 

them in doing so. The recommendations 

contained in the guidance are voluntary. 

Dietary supplement manufacturers will 

only need to collect information to 

substantiate their product’s nutritional 

deficiency, structure/function, or 

general well-being claim if they choose 

to place a claim on their product’s label. 

The standard discussed in the 

guidance for substantiation of a claim 

on the labeling of a dietary supplement 

is consistent with standards set by the 

Federal Trade Commission for dietary 

supplements and other health-related 

products that the claim be based on 

competent and reliable scientific 

evidence. This evidence standard is 

broad enough that some dietary 

supplement manufacturers may only 

need to collect peer-reviewed scientific 

journal articles to substantiate their 

claims; other dietary supplement 

manufacturers whose products have 

properties that are less well documented 

may have to conduct studies to build a 

body of evidence to support their 

claims. It is unlikely that a dietary 

supplement manufacturer will attempt 

to make a claim when the cost of 

obtaining the evidence to support the 

claim outweighs the benefits of having 

the claim on the product’s label. It is 

likely that manufacturers will seek 

substantiation for their claims in the 

scientific literature. 

The time it takes to assemble the 

necessary scientific information to 

support their claims depends on the 

product and the claimed benefits. If the 

product is one of several on the market 

making a particular claim for which 

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. 

In the Federal Register of November 

4, 2014 (79 FR 65409), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. Five comments were 

received. One comment agreed with the 

Agency’s burden estimate while the 

remaining comments were not 

responsive to four information 

collection topics solicited in the notice 

and are therefore not discussed in this 

document. 

FDA estimates 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 

1There 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 


tkelley on DSK3SPTVN1PROD with NOTICES
7612 Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices 

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: February 5, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–02787 Filed 2–10–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0630] 

Safety Considerations To Mitigate the 

Risks of Misconnections With SmallBore Connectors Intended for Enteral 

Applications; Guidance for Industry 

and Food and Drug Administration 

Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Safety Considerations to Mitigate the 

Risks of Misconnections with SmallBore Connectors Intended for Enteral 

Applications.’’ The use of common 

connector designs, such as Luer 

connectors, has led to unintended 

connections between devices that have 

different intended uses and has resulted 

in serious and sometimes fatal 

consequences to patients. This guidance 

provides recommendations to 

manufacturers regarding the 

expectations for design and testing of 

small-bore connectors intended for 

enteral applications (‘‘enteral devices’’). 

FDA is making these recommendations 

to reduce the risk of unintended 

connections between enteral and nonenteral devices. 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. General comments on Agency 

guidance documents are welcome at any 

time. 

ADDRESSES: An electronic copy of the 

guidance document is available for 

download from the Internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Safety 

Considerations to Mitigate the Risks of 

Misconnections with Small-Bore 

Connectors Intended for Enteral 

Applications’’ to the Office of the Center 

Director, Guidance and Policy 

Development, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

Submit electronic comments on the 

guidance 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. Identify comments with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Priya Venkataraman-Rao, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. G222, 

Silver Spring, MD 20993–0002, 301– 

796–6243. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Numerous publications regarding 

patient injury and death from tubing 

and catheter misconnections indicate 

that reports of misconnections have 

increased in frequency over the past 

several years. On July 9, 2010, FDA 

issued a letter to healthcare 

professionals, hospital purchasing 

departments, and manufacturers of 

enteral feeding tubes regarding Luer 

lock misconnections (Ref. 1). FDA 

advised manufacturers to assess the 

risks of misconnections for their devices 

and provide proposed solutions with 

validation for premarket review. At that 

time, some manufacturers were using 

color-coding and labeling to reduce the 

risk of misconnections; others were 

creating proprietary connectors 

designed to be incompatible with 

devices for non-enteral applications 

(‘‘non-enteral devices’’). However, 

recent reports of adverse events have 

demonstrated that reliance on colorcoding and tagging of enteral devices 

alone cannot adequately mitigate the 

risk of misconnections, especially with 

similarly color-coded intravenous PICC 

(percutaneously inserted central 

catheter) lines with Luer connectors. 

This guidance provides updated 

recommendations to manufacturers of 

small-bore connectors intended for 

enteral applications. The guidance 

recommends that manufacturers: (1) 

Design and test enteral connectors based 

upon Association for the Advancement 

of Medical Instrumentation (AAMI)/

CN3:2014 (PS), ‘‘Small-bore connectors 

for liquids and gases in healthcare 

applications—Part 3: Connectors for 

enteral applications’’ and AAMI/

CN20:2014 (PS), ‘‘Small-bore connectors 

for liquids and gases in healthcare 

applications—Part 20: Common test 

methods’’; (2) for connectors that do not 

meet AAMI/CN3:2014 (PS), design and 

test connectors based upon the AAMI/ 

American National Standards Institute 

(ANSI)/International Organization for 

Standardization (ISO) 80369–1 standard 

‘‘Small-bore connectors for liquids and 

gases in healthcare applications—Part 1: 


tkelley on DSK3SPTVN1PROD with NOTICES