Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices 7609 

addition, OHS will share actions taken 

and in progress to address the issues 

and concerns raised in 2014 OHS Tribal 

Consultations. 

The Consultation Session will be 

conducted with elected or appointed 

leaders of Tribal Governments and their 

designated representatives [42 U.S.C. 

9835, Section 640(l)(4)(A)]. Designees 

must have a letter from the Tribal 

Government authorizing them to 

represent the tribe prior to the 

Consultation Session. Other 

representatives of tribal organizations 

and Native nonprofit organizations are 

welcome to attend as observers. 

A detailed report of the Consultation 

Session will be prepared and made 

available within 45 days of the 

Consultation Session to all Tribal 

Governments receiving funds for Head 

Start and Early Head Start programs. 

Tribes wishing to submit written 

testimony for the report should send 

testimony to Robert Bialas at 

Robert.Bialas@acf.hhs.gov either prior 

to the Consultation Session or within 30 

days after the meeting. 

Oral testimony and comments from 

the Consultation Session will be 

summarized in each report without 

attribution, along with topics of concern 

and recommendations. OHS has sent 

hotel and logistical information for the 

New Mexico Consultation Session to 

tribal leaders via email and posted 

information on the Early Childhood 

Learning and Knowledge Center Web 

site at http://eclkc.ohs.acf.hhs.gov/hslc/ 

hs/calendar/tc2015. 

Dated: February 6, 2015. 

Linda K. Smith, 

Deputy Assistant Secretary, Early Childhood 

Development. 

[FR Doc. 2015–02859 Filed 2–10–15; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1031] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Food and Drug 

Administration Recall Regulations 

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 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 0910–0249. 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 Rd., 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. 

FDA Recall Regulation—21 CFR Part 7 

(OMB Control Number 0910–0249)— 

Extension 

Section 701 of the Federal Food, Drug, 

and Cosmetic Act charges the Secretary 

of Health and Human Services, through 

FDA, with the responsibility of assuring 

recalls (21 U.S.C. 371, Regulations and 

Hearings, and 21 CFR part 7, 

Enforcement Policy, Subpart C, Recalls 

(Including Product Corrections)— 

Guidance on Policy, Procedures, and 

Industry Responsibilities) which pertain 

to the recall regulations and provide 

guidance to manufacturers on recall 

responsibilities. The guidelines apply to 

all FDA-regulated products (i.e., food, 

including animal feed; drugs, including 

animal drugs; medical devices, 

including in vitro diagnostic products; 

cosmetics; biological products intended 

for human use; and tobacco). 

These responsibilities include 

providing FDA with complete details of 

the recall including reason(s) for the 

removal or correction, risk evaluation, 

quantity produced, distribution 

information, the firm’s recall strategy, a 

copy of any recall communication(s), 

and a contact official (§ 7.46 (21 CFR 

7.46)); notifying direct accounts of the 

recall, providing guidance regarding 

further distribution, giving instructions 

as to what to do with the product, 

providing recipients with a ready means 

of reporting to the recalling firm (§ 7.49); 

and submitting periodic status reports 

so that FDA may assess the progress of 

the recall. Status report information may 

be determined by, among other things, 

evaluation return reply cards, 

effectiveness checks and product 

returns (§ 7.53); and providing the 

opportunity for a firm to request in 

writing that FDA terminate the recall 

(§ 7.55(b)). 

A search of FDA’s database was 

performed to determine the number of 

recalls that took place during fiscal 

years 2011 to 2013. The resulting 

number of total recalls (11,403) from 

this database search were then averaged 

over the 3 years, and the resulting per 

year average of recalls (3,801) are used 

in estimating the current annual 

reporting burden for this report. The 

resulting number of total terminations 

(11,403) from this database search were 

then averaged over the 3 years, and the 

resulting per year average of 

terminations (3,801) are used in 

estimating the current annual reporting 

burden for this report. 

In the Federal Register of August 4, 

2014 (79 FR 45197), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the total annual 

industry burden to collect and provide 

the previous information to be 721,886 

burden hours. 

The following is a summary of the 

estimated annual burden hours for 

recalling firms (manufacturers, 

processors, and distributors) to comply 

with the voluntary reporting 

requirements of FDA’s recall 

regulations, recognizing that there may 

be a vast difference in the information 

collection and reporting time involved 

in different recalls of FDA’s regulated 

products. 

FDA estimates the burden of this 

collection of information as follows: 


tkelley on DSK3SPTVN1PROD with NOTICES
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