51986 Federal Register / Vol. 76, No. 161 / Friday, August 19, 2011 / Notices 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention, and the Agency for Toxic 

Substances and Disease Registry. 

Dated: August 10, 2011. 

Elizabeth Millington, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. 2011–21167 Filed 8–18–11; 8:45 am] 

BILLING CODE 4160–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

President’s Committee for People With 

Intellectual Disabilities (PCPID); Notice 

of Meeting 

AGENCY: President’s Committee for 

People with Intellectual Disabilities 

(PCPID), Administration for Children 

and Families, HHS. 

ACTION: Notice of meeting. 

DATES: Monday, September 26, 2011, 

from 8:30 a.m. to 5 p.m. EST; and 

Tuesday, September 27, 2011, from 9 

a.m. to 5 p.m. EST. The meeting will be 

open to the public. 

ADDRESSES: The meeting will be held in 

Conference Room 505–A of the Hubert 

H. Humphrey Building, U.S. 

Department of Health and Human 

Services, 200 Independence Avenue, 

SW., Washington, DC 20201. 

Individuals who would like to 

participate via conference call may do 

so by dialing 800–857–4846, pass code: 

14201. Individuals who will need 

accommodations for a disability in order 

to attend the meeting (e.g., sign language 

interpreting services, assistive listening 

devices, materials in alternative format 

such as large print or Braille) should 

notify Genevieve Swift, PCPID 

Executive Administrative Assistant, via 

e-mail at Edith.Swift@acf.hhs.gov, or via 

telephone at 202–619–0634, no later 

than Monday, September 19, 2011. 

PCPID will attempt to meet requests for 

accommodations made after that date, 

but cannot guarantee ability to grant 

requests received after this deadline. All 

meeting sites are barrier free. 

Agenda: Committee members will 

discuss preparation of the PCPID 2011 

Report to the President, including its 

content and format, and related data 

collection and analysis required to 

complete the writing of the Report. 

Additional Information: For further 

information, please contact Laverdia 

Taylor Roach, Senior Advisor, 

President’s Committee for People with 

Intellectual Disabilities, The Aerospace 

Center, Second Floor West, 370 L’Enfant 

Promenade, SW., Washington, DC 

20447. Telephone: 202–619–0634. Fax: 

202–205–9519. E-mail: 

LRoach@acf.hhs.gov. 

SUPPLEMENTARY INFORMATION: PCPID 

acts in an advisory capacity to the 

President and the Secretary of Health 

and Human Services, through the 

Administration on Developmental 

Disabilities, on a broad range of topics 

relating to programs, services and 

supports for persons with intellectual 

disabilities. The PCPID Executive Order 

stipulates that the Committee shall: (1) 

Provide such advice concerning 

intellectual disabilities as the President 

or the Secretary of Health and Human 

Services may request; and (2) provide 

advice to the President concerning the 

following for people with intellectual 

disabilities: (A) Expansion of 

educational opportunities; (B) 

promotion of homeownership; (C) 

assurance of workplace integration; (D) 

improvement of transportation options; 

(E) expansion of full access to 

community living; and (F) increasing 

access to assistive and universally 

designed technologies. 

Dated: August 12, 2011. 

Jamie Kendall, 

Deputy Commissioner, Administration on 

Developmental Disabilities. 

[FR Doc. 2011–21240 Filed 8–18–11; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0410] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Premarket 

Notification for a New Dietary 

Ingredient 

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 

(the PRA). 

DATES: Fax written comments on the 

collection of information by September 

19, 2011. 

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 0910–0330. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–3793. 

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. 

Premarket Notification for a New 

Dietary Ingredient—21 CFR 190.6— 

(OMB Control Number 0910–0330)— 

Extension 

Section 413(a) of the Federal Food, 

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

(21 U.S.C. 350b(a)) provides that at least 

75 days before the introduction or 

delivery for introduction into interstate 

commerce of a dietary supplement that 

contains a new dietary ingredient (NDI), 

a manufacturer or distributor of an NDI, 

or of the dietary supplement that 

contains the NDI, is to submit to FDA 

(as delegate for the Secretary of Health 

and Human Services) the information 

which is the basis on which the 

manufacturer or distributor has 

concluded that a dietary supplement 

containing an NDI will reasonably be 

expected to be safe. Section 190.6 (21 

CFR 190.6) implements this statutory 

provision. Section 190.6(a) requires 

each manufacturer or distributor of a 

dietary supplement containing an NDI, 

or of an NDI, to submit to the Office of 

Nutrition, Labeling, and Dietary 

Supplements notification of the basis for 

their conclusion that said supplement or 

ingredient will reasonably be expected 

to be safe. Section 190.6(b) requires that 

the notification include the following: 

(1) The complete name and address of 

the manufacturer or distributor, (2) the 

name of the NDI, (3) a description of the 

dietary supplements that contain the 

NDI, and (4) the history of use or other 

evidence of safety establishing that the 

dietary ingredient will reasonably be 

expected to be safe. 


jlentini on DSK4TPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 161 / Friday, August 19, 2011 / Notices 51987 

The notification requirements 

described previously are designed to 

enable FDA to monitor the introduction 

into the food supply of NDIs and dietary 

supplements that contain NDIs, in order 

to protect consumers from the 

introduction of unsafe dietary 

supplements into interstate commerce. 

FDA uses the information collected 

under these regulations to help ensure 

that a manufacturer or distributor of a 

dietary supplement containing an NDI is 

in full compliance with the FD&C Act. 

Description of Respondents: The 

respondents to this collection of 

information are firms in the dietary 

supplement industry, including dietary 

supplement and dietary ingredient 

manufacturers, packagers and repackagers, holders, labelers and relabelers, distributors, warehouses, 

exporters, and importers. 

In the Federal Register of June 3, 2011 

(76 FR 32214), FDA published a 60-day 

notice (the June 3, 2011, notice) 

requesting public comment on the 

proposed extension of this collection of 

information. FDA received five letters in 

response to the notice, each containing 

multiple comments. Several comments 

were generally supportive of FDA’s 

information collection provisions in 

§ 190.6. Additional comments were 

outside the scope of the four collection 

of information topics on which the 

notice solicits comments, and will not 

be discussed in this document. 

(Comment 1) FDA received several 

comments on the utility of the 

premarket notification procedures. 

Some comments stated that the 

information collection is necessary for 

the performance of FDA’s functions and 

that the information will be of great 

practical utility to FDA in carrying out 

its role of protecting consumers from the 

introduction of unsafe dietary 

supplements into interstate commerce. 

(Response) FDA agrees. As noted, 

section 413(a) of the FD&C Act requires 

a manufacturer or distributor of an NDI, 

or of the dietary supplement that 

contains the NDI, to submit the 

information which is the basis on which 

the manufacturer or distributor has 

concluded that a dietary supplement 

containing an NDI will reasonably be 

expected to be safe. Section 190.6 

implements this statutory provision, 

and is essential to protecting consumers 

from unsafe dietary supplements. 

(Comment 2) Several comments 

argued that FDA underestimated the 

burden hours associated with 

complying with the provisions of 

§ 190.6. One comment argued that 

FDA’s estimate of 20 hours per 

notification is too low and stated that 

firms filing notifications require 100 to 

350 hours to generate data to meet the 

requirements of an NDI notification. The 

comment argued that FDA did not fully 

consider the time needed to acquire the 

required information. 

(Response) FDA disagrees. FDA 

appreciates the data provided in the 

comment. However, the Agency stands 

by its estimate of the paperwork burden 

resulting from § 190.6. As noted in the 

June 3, 2011, notice, § 190.6(a) requires 

each manufacturer or distributor of a 

dietary supplement containing an NDI, 

or of an NDI, to submit notification of 

the basis for their conclusion that said 

supplement or ingredient will 

reasonably be expected to be safe. The 

Agency believes that there is minimal 

burden on the industry to generate data 

to meet the requirements of the 

premarket notification program because 

the Agency is requesting only that 

information that the manufacturer or 

distributor should already have 

developed as the basis for its conclusion 

that a dietary supplement containing an 

NDI will reasonably be expected to be 

safe. Therefore, the Agency estimates 

that extracting and summarizing the 

relevant information from the 

company’s files, and presenting it in a 

format that will meet the requirements 

of section 413(a) of the FD&C Act and 

§ 190.6 will require a burden of 

approximately 20 hours of work per 

submission. 

(Comment 3) One comment argued 

that FDA’s estimate of 20 hours per 

notification is too low and stated that 

FDA should use burden hour data from 

‘‘successful’’ notifications only, 

indicating that the number of hours 

spent on notifications to which FDA 

does not object more accurately reflect 

the burden on industry. 

(Response) FDA disagrees that the 

estimate of 20 hours per notification is 

too low for the reasons stated in 

response to Comment 2. In addition, the 

Agency does not regularly collect from 

those submitting notifications under 

§ 190.6 information about the number of 

hours they spent preparing the 

notifications, whether ‘‘successful’’ or 

‘‘unsuccessful.’’ FDA appreciates the 

suggestion provided in the comment, 

however, and will consider doing so 

when it prepares its next regular 

information collection request for this 

collection. 

(Comment 4) One comment argued 

that FDA’s estimate that it will receive 

55 premarket notifications annually is 

inaccurate and ‘‘deeply flawed.’’ 

(Response) FDA disagrees that the 

estimate of 55 notifications annually is 

inaccurate. As stated in the June 3, 

2011, notice, the estimated number of 

premarket notifications is an average 

based on the Agency’s experience with 

notifications received during the last 3 

years. FDA received 77 notifications in 

2008, 39 notifications in 2009, and 48 

notifications in 2010, for an average of 

55 notifications. The sum of 77 + 39 + 

48 equals 164. Dividing that sum by 3 

yields an average of 54.66, which has 

been rounded up to 55. 

(Comment 5) Several comments 

argued that FDA incorrectly estimated 

that there are no capital costs associated 

with submitting premarket notifications 

under § 190.6. Comments argued that 

FDA did not fully consider that notifiers 

invest significant capital resources in 

hiring consultants to extract and 

summarize information for NDI 

notifications, paying for full-text 

scientific journal articles and obtaining 

legal review of NDI notifications. 

(Response) FDA disagrees. The 

comment mischaracterizes the 

significant costs associated with hiring 

consultants, obtaining reference 

materials, and securing legal review of 

a notification as capital costs. For 

purposes of information collection 

requests under the PRA, capital costs 

are costs for equipment, machinery, and 

construction that, if not for FDA’s 

request or requirement, the respondent 

would not incur. This includes buying 

new software and new computer 

equipment; monitoring, sampling, 

drilling and testing equipment; record 

storage facilities; the cost of purchasing 

or contracting out information 

collection services; and, postage costs to 

mail in a report. Capital costs do not 

include costs to achieve regulatory 

compliance with requirements not 

associated with the information 

collection. Hiring consultants to extract 

and summarize information for NDI 

notifications, paying for full-text 

scientific journal articles and obtaining 

legal review of NDI notifications are 

costs associated with developing 

information that the manufacturer or 

distributor uses to satisfy itself that a 

dietary supplement containing an NDI is 

in full compliance with section 413(a) of 

the FD&C Act; thus, these costs are not 

a capital cost because they are costs 

associated with achieving regulatory 

compliance with requirements of the 

FD&C Act, not costs associated 

specifically with filing a notification 

under § 190.6. FDA notes that it has 

added a reference to these costs as 

‘‘Costs to Respondent’’ in section 12(b) 

of the supporting statement component 

of the information collection request 

that it has submitted to OMB. 

(Comment 6) Several comment letters 

noted that on July 5, 2011, FDA issued 

a draft guidance entitled ‘‘Dietary 

Supplements: New Dietary Ingredient 


jlentini on DSK4TPTVN1PROD with NOTICES
51988 Federal Register / Vol. 76, No. 161 / Friday, August 19, 2011 / Notices 

Notifications and Related Issues’’ 

(available at http://www.fda.gov/Food/

GuidanceComplianceRegulatory

Information/GuidanceDocuments/ 

DietarySupplements/ucm257563.htm). 

Some comments argued that FDA 

underestimated the burden of the 

notification procedures under § 190.6 

because it failed to take into account the 

provisions of the new draft guidance. 

(Response) FDA disagrees that we 

underestimated the burden of the 

notification procedures under § 190.6. 

The collection of information analysis 

in the June 3, 2011, notice was limited 

to the sole collection of information 

contained in § 190.6; that is, the 

regulation itself and not the provisions 

of the new draft guidance. The 

notification requirements set forth in 

§ 190.6 remain unchanged. The notice of 

availability for the new draft guidance 

(76 FR 39111, July 5, 2011) states that 

FDA will estimate the paperwork 

burden of the draft guidance document 

and submit it for OMB review under the 

PRA in a future issue of the Federal 

Register. Comments on the new draft 

guidance and any information collection 

provisions therein are outside the scope 

of the comment request in the June 3, 

2011, notice, and will not be discussed 

in this document. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Number of 

respondents 

Number of responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

190.6 .................................................................................... 55 1 55 20 1,100 

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

As previously discussed, the Agency 

believes that there will be minimal 

burden on the industry to generate data 

to meet the requirements of the 

premarket notification program because 

the Agency is requesting only that 

information that the manufacturer or 

distributor should already have 

developed as the basis for its conclusion 

that a dietary supplement containing an 

NDI will reasonably be expected to be 

safe. Therefore, the Agency estimates 

that extracting and summarizing the 

relevant information from the 

company’s files, and presenting it in a 

format that will meet the requirements 

of section 413(a) of the FD&C Act and 

§ 190.6 will require a burden of 

approximately 20 hours of work per 

submission. 

The estimated number of premarket 

notifications and hours per response is 

an average based on the Agency’s 

experience with notifications received 

during the last 3 years and information 

from firms that have submitted recent 

premarket notifications. FDA received 

77 notifications in 2008, 39 notifications 

in 2009, and 48 notifications in 2010, 

for an average of 55 notifications. 

Accordingly, we estimate that 55 

respondents will submit 1 premarket 

notification each and that it will take a 

respondent 20 hours to prepare the 

notification, for a total of 1,100 hours. 

Dated: August 15, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–21237 Filed 8–18–11; 8:45 am] 

BILLING CODE 4160–01–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. 

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 September 

19, 2011. 

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 0910–0626. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

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 Food, Drug, 

and Cosmetic Act (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 statement 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 FDA’s 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 


jlentini on DSK4TPTVN1PROD with NOTICES