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Treatment; Draft Guidance for 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availability of a draft guidance for 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

63130 Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Notices 

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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http://

www.regulations.gov. 

Dated: October 15, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–25048 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–2013–D–0710] 

Guidance for Industry on 

Circumstances That Constitute 

Delaying, Denying, Limiting, or 

Refusing a Drug Inspection; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Circumstances that Constitute 

Delaying, Denying, Limiting, or 

Refusing a Drug Inspection.’’ The Food 

and Drug Administration Safety and 

Innovation Act (FDASIA) added a 

provision to the Food, Drug, and 

Cosmetic Act (the FD&C Act) 

concerning inspections that makes a 

drug adulterated. This guidance defines 

the types of actions, inaction, and 

circumstances that FDA considers to 

constitute delaying, denying, or limiting 

inspection, or refusing to permit entry 

or inspection for the purposes of making 

a drug adulterated. 

DATES: Submit either electronic or 

written comments on Agency guidance 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Office of Policy and Risk Management, 

Office of Regulatory Affairs, Food and 

Drug Administration, 12420 Parklawn 

Dr., rm. 4138, Rockville, MD 20857. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

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. 

FOR FURTHER INFORMATION CONTACT: 

Emily M. Leongini, Office of Policy and 

Risk Management, Office of Regulatory 

Affairs, Food and Drug Administration, 

10902 New Hampshire Ave., Bldg. 32, 

rm. 4339, Silver Spring, MD 20903, 

301–796–5300. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Circumstances that Constitute 

Delaying, Denying, Limiting, or 

Refusing a Drug Inspection.’’ On July 9, 

2012, FDASIA (Pub. L. 112–144) was 

signed into law. Section 707 of FDASIA 

adds 501(j) to the FD&C Act to make a 

drug adulterated that ‘‘has been 

manufactured, processed, packed, or 

held in any factory, warehouse, or 

establishment and the owner, operator, 

or agent of such factory, warehouse, or 

establishment delays, denies, or limits 

an inspection, or refuses to permit entry 

or inspection.’’ As required by Section 

707, FDA is issuing this guidance to 

define the types of action, inaction, and 

circumstances that FDA considers to 

constitute delaying, denying, or limiting 

inspection, or refusing to permit entry 

or inspection for the purposes of Section 

501(j) of the FD&C Act. 

In July 2013, FDA issued a draft 

guidance for industry of the same title 

(78 FR 42387, July 15, 2013). In 

response to docket comments, we 

revised the guidance to clarify FDA’s 

expectations regarding the types of 

action, inaction, and circumstances that 

make a drug adulterated under 501(j) of 

the FD&C Act. Among other things, we 

added examples that may constitute 

reasonable explanations for actions, 

inactions, or circumstances that could 

otherwise be considered delaying, 

denying, or limiting inspection, or 

refusing to permit entry or inspection. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on ‘‘Circumstances that 

Constitute Delaying, Denying, Limiting, 

or Refusing a Drug Inspection.’’ 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. 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Regulatory

Information/Guidances/ucm122044.htm 

or http://www.regulations.gov. 

Dated: October 15, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–25033 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–0001] 

Seventh Annual Sentinel Initiative; 

Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) is announcing a public workshop 

entitled ‘‘Seventh Annual Sentinel 

Initiative Public Workshop.’’ Convened 

by the Engelberg Center for Health Care 

Reform at the Brookings Institution and 

supported by a cooperative agreement 

with FDA, this 1-day workshop will 

bring the stakeholder community 

together to discuss a variety of topics on 

active medical product surveillance. 

Topics will include an overview of the 

transition from the Mini-Sentinel pilot 

program to the full Sentinel System and 

what that means for patients and other 

critical stakeholders. Additionally, 

panelists will discuss the future of the 

Sentinel System and opportunities to 

expand its medical product surveillance 

capabilities. This workshop will also 

engage stakeholders to discuss current 

and emerging Sentinel projects. 

mstockstill on DSK4VPTVN1PROD with NOTICES