5824 Federal Register / Vol. 87, No. 22 / Wednesday, February 2, 2022 / Notices 

Data (OMB #0970–0389; expiration 6/ 

30/2022). There are minor updates to 

the existing Form 1. 

DATES: Comments due within 30 days of 

publication. OMB must make a decision 

about the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. You can also obtain 

copies of the proposed collection of 

information by emailing infocollection@

acf.hhs.gov. Identify all emailed 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: Section 511(h)(2)(A) of 

Title V of the Social Security Act 

created the MIECHV Program and 

authorizes the Secretary of HHS to 

award grants to Indian tribes (or a 

consortium of Indian tribes), tribal 

organizations, or urban Indian 

organizations to conduct an early 

childhood home visiting program. The 

legislation set aside 3 percent of the 

total MIECHV program appropriation for 

grants to tribal entities. Tribal MIECHV 

grants, to the greatest extent practicable, 

are to be consistent with the 

requirements of the MIECHV grants to 

states and jurisdictions and include 

conducting a needs assessment and 

establishing quantifiable, measurable 

benchmarks. ACF’s OCC, in 

collaboration with the Health Resources 

and Services Administration, Maternal 

and Child Health Bureau, awards grants 

for the Tribal MIECHV Program. The 

Tribal MIECHV grant awards support 5- 

year cooperative agreements to conduct 

community needs assessments; plan for 

and implement high-quality, culturally 

relevant, evidence-based home visiting 

programs in at-risk tribal communities; 

and participate in research and 

evaluation activities to build the 

knowledge base on home visiting among 

Native populations. 

In Year 1 of the cooperative 

agreement, grantees must (1) conduct a 

comprehensive community needs and 

readiness assessment, and (2) develop a 

plan to respond to identified needs. 

Following each year that Tribal 

MIECHV grantees implement home 

visiting services, they must submit Form 

1: Demographic and Service Utilization 

Data. The Form 1 data are used to help 

ACF better understand the population 

receiving services from Tribal MIECHV 

grantees and the degree to which they 

are using services, as well as better 

understand the Tribal MIECHV 

workforce. Overall, this information 

collection will provide valuable 

information to HHS that will guide 

understanding of the Tribal MIECHV 

Program and the provision of technical 

assistance to Tribal MIECHV Program 

grantees. Changes from the previous 

form are minor, including adding a 

virtual home visit field and revising 

certain terms and definitions to make 

reporting on the areas more concise and 

easier for grantees to report. 

Respondents: Tribal MIECHV Program 

Grantees. 

ANNUAL BURDEN ESTIMATES

Instrument Total number 

of respondents 

Annual number 

of responses 

per respondent 

Average 

burden hours 

per response 

Annual 

burden hours 

Tribal MIECHV Form 1 .................................................................................. 23 1 500 11,500 

Estimated Total Annual Burden 

Hours: 11,500. 

Authority: Title V of the Social 

Security Act, sections 511(e)(8)(A) and 

511(h)(2)(A). 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–02157 Filed 2–1–22; 8:45 am] 

BILLING CODE 4184–43–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0429] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance on 

Meetings With Industry and 

Investigators on the Research and 

Development of Tobacco Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection aspects of the ‘‘Guidance on 

Meetings with Industry and 

Investigators on the Research and 

Development of Tobacco Products.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by April 4, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before April 4, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of April 4, 2022. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 


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Federal Register / Vol. 87, No. 22 / Wednesday, February 2, 2022 / Notices 5825 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2012–D–0429 for ‘‘Guidance on 

Meetings with Industry and 

Investigators on the Research and 

Development of Tobacco Products.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Guidance on Meetings With Industry 

and Investigators on the Research and 

Development of Tobacco Products 

OMB Control Number 0910–0731— 

Extension 

The Family Smoking Prevention and 

Tobacco Control Act (Pub. L. 111–31) 

offers tobacco product manufacturers 

several pathways to obtain an order 

from FDA to authorize the marketing of 

a new tobacco product before it may be 

introduced or delivered into interstate 

commerce. To provide assistance with 

these pathways to market products, FDA 

will meet with tobacco product 

manufacturers, importers, researchers, 

and investigators (or their 

representatives) when appropriate as 

described in ‘‘Guidance on Meetings 

with Industry and Investigators on the 

Research and Development of Tobacco 

Products.’’ This guidance is intended to 

assist persons who seek meetings with 

FDA relating to their research to inform 

the regulation of tobacco products, or to 

support the development or marketing 

of tobacco products. The original 

guidance issued in 2012 was revised for 

updating and clarity in July 2016. 

In the guidance, the Agency 

discusses, among other things: 

• What information FDA 

recommends persons include in a 

meeting request; 

• How and when to submit a request; 

and 

• What information FDA 

recommends persons submit prior to a 

meeting. 

This guidance describes two 

collections of information: (1) The 

submission of a meeting request 

containing certain information and (2) 

the submission of an information 

package in advance of the meeting. The 

purpose of this proposed information 

collection is to allow FDA to conduct 

meetings with tobacco manufacturers, 

importers, researchers, and investigators 

in an effective and efficient manner. 

FDA issued this guidance and the 

revisions consistent with FDA’s good 

guidance practices regulations (21 CFR 

10.115). 

Meeting Requests: The guidance sets 

forth FDA’s recommendations for 

materials to be included in a request for 

a meeting with FDA to discuss the 

research and development of tobacco 

products. In the guidance, FDA 

recommends that the following 


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information be included in the meeting 

request: 

1. Product name 

2. FDA-assigned Submission Tracking 

Number(s) of prior submissions (e.g., 

premarket applications, meeting 

requests) for the product and relevant 

product version(s) (if applicable); 

3. Product category (e.g., cigarettes, 

smokeless tobacco) (if applicable); 

4. Product use (indicate for consumer 

use or for further manufacturing); 

5. Contact information for the 

authorized point of contact for the 

company requesting the meeting; 

6. The topic of the meeting being 

requested (e.g., a new tobacco product 

application, an application for 

permission to market a modified risk 

tobacco product, or investigational use 

of a new tobacco product); 

7. A brief statement of the purpose of 

the meeting, which could include a 

discussion of the types of studies or data 

to be discussed at the meeting, the 

general nature of the primary questions 

to be asked, and where the meeting fits 

in the overall product development 

plans; 

8. A preliminary list of the specific 

objectives/outcomes expected from the 

meeting; 

9. A preliminary proposed agenda, 

including an estimate of the time 

needed and a designated speaker for 

each agenda item; 

10. A preliminary list of specific 

critical questions, grouped by discipline 

(e.g., chemistry, clinical, nonclinical); 

11. A list of all individuals who will 

attend the meeting on behalf of the 

tobacco product manufacturer, importer, 

researcher, or investigator, including 

titles and responsibilities; 

12. The date on which the meeting 

information package will be received by 

FDA; and 

13. Suggested format of the meeting 

(e.g., conference call, in-person meeting 

at FDA offices, video conference, or 

written response) and suggested dates 

and times for the meeting. Meetings are 

usually scheduled for 1 hour. FDA is 

proposing a meeting request include the 

FDA-assigned submission tracking 

numbers of relevant product version(s), 

if applicable, to allow for FDA to 

reference such information to better 

assess and respond to the issues and 

questions raised in the meeting request. 

This information will be used by the 

Agency to: (1) Determine the utility of 

the meeting, (2) identify Agency staff 

necessary to discuss proposed agenda 

items, and (3) schedule the meeting. 

Meeting Information Packages: An 

individual submitting a meeting 

information package to FDA in advance 

of a meeting should provide summary 

information relevant to the product and 

supplementary information pertaining 

to any issue raised by the individual or 

FDA to be discussed at the meeting. As 

stated in the guidance, FDA 

recommends that meeting information 

packages generally include updates of 

information that was submitted with the 

meeting request and, as applicable: 

1. Product composition and design 

data summary; 

2. Manufacturing and process control 

data summary; 

3. Nonclinical data summary; 

4. Clinical data summary; 

5. Behavioral and product use data 

summary; 

6. User and nonuser perception data 

summary; and 

7. Investigational plans for studies 

and surveillance of the tobacco product, 

including a summary of proposed study 

protocols containing the following 

information (as applicable): 

a. Study objective(s); 

b. Study hypotheses; 

c. Study design; 

d. Study population (inclusion/ 

exclusion criteria, comparison group(s)); 

e. Human subject protection 

information, including Institutional 

Review Board information; 

f. Primary and secondary endpoints 

(definition and success criteria); 

g. Sample size calculation; 

h. Data collection procedures; 

i. Duration of follow up and baseline 

and follow up assessments, and 

j. Data analysis plan(s). 

The purpose of the information 

package is to provide Agency staff the 

opportunity to adequately prepare for 

the meeting, including the review of 

relevant data concerning the product. In 

the Agency’s experience, reviewing 

such information is critical to achieving 

a productive meeting. If the information 

package was previously submitted in 

the meeting request, it should be 

revised, as applicable, so that the 

information reflects the most current 

and accurate information available. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total 

hours 

Meeting Requests 

Combining and Sending Meeting Request Letters for Manufacturers, Importers, and Researchers .......................... 60 1 60 10 600 

Meeting Information Packages 

Combining and Submitting Meeting Information Packages 

for Manufacturers, Importers, and Researchers .............. 60 1 60 18 1,080 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,680 

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

FDA’s estimate of the number of 

respondents for meeting requests in 

table 1 is based on the number of 

meeting requests received and projected 

over the next 3 years. FDA estimates 

that 60 preapplication meetings will be 

requested. 

The hours per response for combining 

and sending meeting request letters are 

estimated at 10 hours each, and the total 

burden hours for meeting requests are 

expected to be 600 hours. Based on 

FDA’s experience, the Agency expects it 

will take respondents this amount of 

time to prepare, gather, copy, and 

submit brief statements about the 

product and a description of the 

purpose and details of the meeting. 

FDA estimates that 60 respondents 

will compile meeting information 

packages and submit to FDA at 18 hours 

per response. Based on FDA’s 

experience, the Agency expects that it 


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will take respondents, collectively, 

1,080 hours to gather, copy, and submit 

brief statements about the product, a 

description of the details of the 

anticipated meeting, and data and 

information, including identifying prior 

FDA submissions for the product or 

relevant versions of the product, that 

generally would already have been 

generated for the planned research and/ 

or product development. 

The total number of burden hours for 

this collection of information is 

estimated to be 1,680 hours (600 hours 

to prepare and submit meeting requests 

and 1,080 hours to prepare and submit 

information packages). Our estimated 

burden for the information collection 

reflects an overall decrease of 644 hours. 

We attribute this adjustment to a 

decrease in the number of submissions 

we received over the last few years and 

our projections for the next 3 years. 

Dated: January 25, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02055 Filed 2–1–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0079] 

Hikma Pharmaceuticals USA, Inc., et 

al.; Withdrawal of Approval of 29 New 

Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of 29 new drug 

applications (NDAs) from multiple 

applicants. The applicants notified the 

Agency in writing that the drug 

products were no longer marketed and 

requested that the approval of the 

applications be withdrawn. 

DATES: Approval is withdrawn as of 

March 4, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Lehrfeld, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6226, 

Silver Spring, MD 20993–0002, 301– 

796–3137, Kimberly.Lehrfeld@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

applicants listed in the table have 

informed FDA that these drug products 

are no longer marketed and have 

requested that FDA withdraw approval 

of the applications under the process in 

§ 314.150(c) (21 CFR 314.150(c)). The 

applicants have also, by their requests, 

waived their opportunity for a hearing. 

Withdrawal of approval of an 

application or abbreviated application 

under § 314.150(c) is without prejudice 

to refiling. 

Application No. Drug Applicant 

NDA 006134 ........................ Dolophine (methadone hydrochloride (HCl)) Tablets, 5 

milligrams (mg), and 10 mg.

Hikma Pharmaceuticals USA, Inc., 1809 Wilson Rd., 

Columbus, OH 43228. 

Dolophine (methadone HCl) Syrup, 10 mg/30 milliliter 

(mL).

NDA 006882 ........................ Phisohex (hexachlorophene) Emulsion, 3% ................... Sanofi-aventis U.S. LLC, 55 Corporate Dr., Bridgewater, NJ 08807. 

NDA 009818 ........................ Kemadrin (procyclidine HCl) Tablets, 2 mg, and 5 mg .. Monarch Pharmaceuticals, LLC, c/o Pfizer, Inc., 235 

East 42nd St., New York, NY 10017. 

NDA 012301 ........................ Librium (chlordiazepoxide HCl), Injection, 100 mg/ampule.Bausch Health US, LLC, 400 Somerset Corporate 

Blvd., Bridgewater, NJ 08807. 

NDA 013416 ........................ Norgesic (orphenadrine citrate, aspirin, and caffeine) 

Tablets, 25 mg/385 mg/30 mg.

Bausch Health US, LLC. 

Norgesic Forte (orphenadrine citrate, aspirin, and caffeine) Tablets, 50 mg/770 mg/60 mg.

NDA 014228 ........................ Spandin (aspirin and sodium salicylate) Time-released 

Tablets, 7.5 grains/2.5 grains.

Abbott Healthcare Pvt. Ltd., c/o G&L Scientific, Independence Blvd., 4th Floor, Warren, NJ 07059. 

NDA 016194 ........................ Talwin (pentazocine lactate) Injection, equivalent to 

(EQ) 30 mg base/mL.

Hospira Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL 60045. 

NDA 016418 ........................ Inderal (propranolol HCl) Tablets, 10 mg, 20 mg, 40 

mg, 60 mg, 80 mg, and 90 mg.

Wyeth Pharmaceuticals LLC, 235 E. 42nd St., New 

York, NY 10017. 

NDA 016704 ........................ Resectisol (mannitol) Irrigation Solution, 5 grams (g)/ 

100 mL.

B. Braun Medical Inc., 901 Marcon Blvd., Allentown, PA 

18109. 

NDA 016762 ........................ Inderal (propranolol HCl) Tablets, 10 mg, 20 mg, 40 

mg, 60 mg, and 80 mg.

Wyeth Pharmaceuticals LLC. 

NDA 016954 ........................ Micronor (norethindrone) Tablets, 0.35 mg .................... Janssen Pharmaceuticals, Inc., 1125 TrentonHarbourton Rd., Titusville, NJ 08560. 

NDA 017013 ........................ Sodium Chloride Injection, 20 g/100 mL ........................ Abbott Healthcare Pvt. Ltd., c/o G&L Scientific. 

NDA 017683 ........................ Inderal (propranolol HCL) Tablets, 10 mg, 20 mg, 40 

mg, 60 mg, and 80 mg.

Wyeth Pharmaceuticals LLC. 

NDA 018423 ........................ Hibiclens (chlorhexidine gluconate) Sponge, 4% ........... Mo ̈lnlycke Health Care, 5445 Triangle Pkwy., Suite 

400, Peachtree Corners, GA 30092. 

NDA 018703 ........................ Zantac (ranitidine HCl) Tablets, EQ 150 mg base, and 

EQ 300 mg base.

GlaxoSmithKline Intellectual Property Ltd. England, c/o 

GlaxoSmithKline, 5 Crescent Dr., Philadelphia, PA 

19112. 

NDA 019387 ........................ Profenal (suprofen) Ophthalmic Solution, 1% ................ Alcon Laboratories, Inc., 6201 South Freeway, Fort 

Worth, TX 76134–2099. 

NDA 019530 ........................ Ucephan (sodium benzoate and sodium phenylacetate) 

Solution, 100 mg/mL; 100 mg/mL.

B. Braun Medical Inc. 

NDA 019675 ........................ Zantac (ranitidine HCl) Syrup, EQ 15 mg base/mL ........ GlaxoSmithKline Intellectual Property Ltd. England, c/o 

GlaxoSmithKline. 

NDA 019814 ........................ Betagan (levobunolol HCl) Ophthalmic Solution, 0.25% Allergan, Inc. 

NDA 019927 ........................ Nizoral (ketoconazole) Shampoo, 2% ............................ Janssen Pharmaceuticals, Inc. 


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