63128 Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Notices 

The reporting and third-party 

disclosure burden estimates are based 

on our records, which show that there 

are 5 manufacturers of infant formula 

and that there have been, on average, 2 

infant formula recalls per year for the 

past 3 years. Based on this information, 

we estimate that there will be, on 

average, approximately 2 infant formula 

recalls per year over the next 3 years. 

Thus, we estimate that 2 respondents 

will conduct recalls annually pursuant 

to §§ 107.230, 107.240, and 107.250. 

The estimated number of respondents 

for § 107.260 is minimal because we 

seldom use this section; therefore, we 

estimate that there will be 1 or fewer 

respondents annually for § 107.260. The 

estimated number of hours per response 

is an average based on our experience 

and information from firms that have 

conducted recalls. We estimate that 2 

respondents will conduct infant formula 

recalls under § 107.230 and that it will 

take a respondent 4,450 hours to comply 

with the requirements of that section, 

for a total of 8,900 hours. We estimate 

that 2 respondents will conduct infant 

formula recalls under § 107.240 and that 

it will take a respondent 1,482 hours to 

comply with the requirements of that 

section, for a total of 2,964 hours. We 

estimate that 2 respondents will submit 

recommendations for termination of 

infant formula recalls under § 107.250 

and that it will take a respondent 120 

hours to comply with the requirements 

of that section, for a total of 240 hours. 

Finally, we estimate that 1 respondent 

will need to carry out additional 

effectiveness checks and issue 

additional notifications, for a total of 

625 hours. 

Under 5 CFR 1320.3(b)(2), the time, 

effort, and financial resources necessary 

to comply with a collection of 

information are excluded from the 

burden estimate if the reporting, 

recordkeeping, or disclosure activities 

needed to comply are usual and 

customary because they would occur in 

the normal course of activities. No 

burden has been estimated for the 

recordkeeping requirement in § 107.280 

because these records are maintained as 

a usual and customary part of normal 

business activities. Manufacturers keep 

infant formula distribution records for 

the prescribed period as a matter of 

routine business practice. 

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

disclosures per 

respondent 

Total annual 

disclosures 

Average burden 

per disclosure Total hours 

107.230; elements of infant formula recall ...... 2 1 2 50 100 

107.260; revision of an infant formula recall ... 1 1 1 25 25 

Total .......................................................... ............................ ............................ ............................ ............................ 125 

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

Table 2 reports our third-party 

disclosure burden estimates for 

§§ 107.230 and 107.260. The estimated 

burden hours per disclosure is an 

average based on our experience. The 

third-party disclosure burden in 

§ 107.230 is the requirement to 

promptly notify each affected directaccount (customer) about the recall, and 

if the recalled formula presents a risk to 

human health, the requirement that the 

recalling firm must also request that 

each establishment that sells the 

recalled formula post a notice of the 

recall at the point of purchase. We 

estimate that 2 respondents will 

conduct infant formula recalls under 

§ 107.230 and that it will take a 

respondent 50 hours to comply with the 

third-party disclosure requirements of 

that section, for a total of 100 hours. The 

third-party disclosure burden in 

§ 107.260 is the requirement to issue 

additional notifications where the recall 

strategy or implementation is 

determined to be deficient. We estimate 

that 1 respondent will issue additional 

notifications under § 107.260 and that it 

will take a respondent 25 hours to 

comply with the third-party disclosure 

requirements of that section, for a total 

of 25 hours. 

Dated: October 16, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–25105 Filed 10–21–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1104] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; State Petitions for 

Exemption From Preemption 

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 November 

21, 2014. 

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 0910–0277. 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. 

State Petitions for Exemption From 

Preemption—21 CFR 100.1(d) (OMB 

Control Number 0910–0277)— 

(Extension) 

Under section 403A(b) of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 343–1(b)), states 

may petition FDA for exemption from 

Federal preemption of state food 

labeling and standard of identity 

requirements. Section 100.1(d) (21 CFR 

100.1(d)) sets forth the information a 

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Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Notices 63129 

state is required to submit in such a 

petition. The information required 

under § 100.1(d) enables FDA to 

determine whether the state food 

labeling or standard of identity 

requirement satisfies the criteria of 

section 403A(b) of the FD&C Act for 

granting exemption from Federal 

preemption. 

In the Federal Register of August 7, 

2014 (79 FR 46269), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

We estimate the annual burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR 100.1(d) Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Avg. burden per 

response Total hours 

Form of petition ................................................ 1 1 1 40 40 

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

The reporting burden for § 100.1(d) is 

minimal because petitions for 

exemption from preemption are seldom 

submitted by states. In the last 3 years, 

we have received one new petition for 

exemption from preemption; therefore, 

we estimate that one or fewer petitions 

will be submitted annually. 

Dated: October 16, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–25106 Filed 10–21–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1540] 

Migraine: Developing Drugs for Acute 

Treatment; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Migraine: Developing 

Drugs for Acute Treatment.’’ The 

purpose of this guidance is to assist 

sponsors in the clinical development of 

drugs for the acute treatment of 

migraine. This guidance focuses on 

specific drug development and trial 

design issues that are unique to the 

study of drugs for the acute treatment of 

migraine. This guidance is intended to 

serve as a focus for continued 

discussions among the Division of 

Neurology Products, pharmaceutical 

sponsors, the academic community, and 

the public. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by December 22, 

2014. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

Submit electronic comments on the 

draft 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. 

FOR FURTHER INFORMATION CONTACT: Eric 

Bastings, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 4338, Silver Spring, 

MD 20993–0002, 301–796–1039. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Migraine: Developing Drugs for Acute 

Treatment.’’ The purpose of this 

guidance is to assist sponsors in the 

clinical development of drugs for the 

acute treatment of migraine. This 

guidance focuses on specific drug 

development and trial design issues that 

are unique to the study of drugs for the 

acute treatment of migraine. This 

guidance is intended to serve as a focus 

for continued discussions among the 

Division of Neurology Products, 

pharmaceutical sponsors, the academic 

community, and the public. 

Migraine is a chronic neurovascular 

disorder characterized by recurrent 

attacks of often severe headache, 

typically presenting with nausea, 

vomiting, and sensitivity to light and/or 

sound. Pharmacologic approaches to the 

treatment of migraine include drugs to 

treat acute migraine attacks as they arise 

(acute treatment of migraine) and drugs 

to reduce the frequency of migraine 

attacks (preventive treatment). This 

guidance addresses the development 

program of drugs for the acute treatment 

of migraine, including trial population, 

trial design, dose selection, efficacy 

endpoints, and statistical 

considerations. The guidance also 

discusses safety considerations, 

pediatric studies, and labeling 

considerations. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on developing drugs for the acute 

treatment of migraine. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR parts 201, 312, 

and 314 have been approved under 

OMB control numbers 0910–0572, 

0910–0014, and 0910–0001, 

respectively. 

III. 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 

mstockstill on DSK4VPTVN1PROD with NOTICES