Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Notices 37871 

manufacturers can be compliant with 

current good manufacturing practice 

(CGMP) requirements for preventing 

cross-contamination. This guidance also 

provides information regarding the 

relative health risk of, and the potential 

for, cross-reactivity in the classes of 

non-penicillin beta-lactam antibacterial 

drugs and non-antibacterial beta-lactam 

compounds. This guidance recommends 

that manufacturers should manufacture 

non-penicillin beta-lactam antibacterial 

drugs with complete and 

comprehensive separation from 

manufacturing operations of other 

drugs. For manufacturers of nonantibacterial beta-lactam compounds, 

this guidance provides 

recommendations on crosscontamination prevention strategies, 

including examples of relevant design 

features and control approaches for 

those seeking to justify a crosscontamination prevention strategy other 

than complete and comprehensive 

separation when appropriate. 

This guidance revises the guidance of 

the same title issued on April 17, 2013 

(78 FR 22887). Significant changes from 

the 2013 guidance include: 

• Clarifying that the scope of the 

guidance also includes all compounds, 

including intermediates or derivatives, 

that are not a penicillin, have a 

chemical structure that includes one or 

more beta-lactam rings, and have a 

mechanism of action other than an 

antibacterial mechanism of action; 

• Providing FDA’s interpretation of 

terms, such as allergic reaction, crossreactivity, and complete and 

comprehensive separation, used in this 

guidance; 

• Clarifying the distinction between 

non-penicillin beta-lactam antibacterial 

drug(s) and non-antibacterial betalactam compound(s)—in terms of the 

cross-contamination and patient 

exposure risks and the control strategies 

appropriate for manufacturing 

operations involving each category; and 

• Providing recommendations for 

drug manufacturers that seek to justify 

alternative cross-contamination 

prevention strategies for nonantibacterial beta-lactam compounds. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

replace the 2013 guidance and represent 

the current thinking of FDA on ‘‘NonPenicillin Beta-Lactam Drugs: A CGMP 

Framework for Preventing CrossContamination.’’ It does not establish 

any rights for any person and is not 

binding on FDA or the public. You can 

use an alternative approach if it satisfies 

the requirements of the applicable 

statutes and regulations. 

II. The Paperwork Reduction Act of 

1995 

FDA tentatively concludes that this 

draft guidance contains no new 

collection of information. Therefore, 

clearance by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521) is not required. However, 

this draft guidance refers to previously 

approved FDA collections of 

information. These collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR parts 210 and 

211 have been approved under OMB 

control number 0910–0139; and the 

collections of information in 21 CFR 

part 314 have been approved under 

OMB control number 0910–0001. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: June 17, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13513 Filed 6–23–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0319] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Dear Healthcare 

Provider Letters: Improving 

Communication of Important Safety 

Information 

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 

requests comments on information 

collection associated with the 

communication of important safety 

information to medical practitioners. 

DATES: Submit either electronic or 

written comments on the collection of 

information by August 23, 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 August 23, 

2022. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of August 23, 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 

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 


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37872 Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Notices 

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 Docket No. FDA–2010–D– 

0319 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Dear 

Healthcare Provider Letters: Improving 

Communication of Important Safety 

Information.’’ 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: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, 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. 

Improving Communication of 

Important Safety Information—21 CFR 

Part 200 

OMB Control Number 0910–0754— 

Extension 

This information collection supports 

Agency regulations and 

recommendations found in associated 

Agency guidance, as discussed below. 

Under section 705 of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 375), the Secretary of the 

Department of Health and Human 

Services (the Secretary) may require 

dissemination of information for drugs 

in situations that involve, in the 

Secretary’s opinion, ‘‘imminent danger 

to health, or gross deception of the 

consumer.’’ Implementing regulations 

are found in § 200.5 (21 CFR 200.5) and 

outline the general provisions for ‘‘Dear 

Healthcare Provider’’ (DHCP) letters that 

manufacturers and distributors 

disseminate about important drug 

warnings, important prescribing 

information, and important correction of 

drug information. The regulations also 

prescribe certain format and content 

instructions regarding the dissemination 

of covered information. Manufacturers 

or distributors send DHCP letters to 

physicians and other healthcare 

providers to communicate an important 

drug warning, a change in prescribing 

information, or a correction of 

misinformation in prescription drug 

promotional labeling or advertising. We 

developed the guidance document 

entitled ‘‘Dear Healthcare Provider 

Letters: Improving Communication of 

Important Safety Information’’ (January 

2014), available at https://www.fda.gov/ 

media/79793/download, to provide 

instructions and recommendations to 

respondents on implementing the 

applicable requirements. All Agency 

guidance documents are issued 

consistent with our good guidance 

practice regulations at 21 CFR 10.115. 

In addition to the content and format 

recommendations for each type of DHCP 

letter, the guidance also includes 

recommendations on consulting with 

FDA on: (1) how to develop a DHCP 

letter; (2) when to send a letter; (3) what 

type of letter to send; and (4) how to 

assess the letter’s impact. 

We estimate the burden of the 

information collection as follows: 


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Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Notices 37873 

1Prior to this, the formula was based on poverty 

data from the decennial Census long-form, which 

was replaced with the American Community 

Survey. 

2https://www.census.gov/library/working-papers/ 

2021/acs/2021_CensusBureau_01.html. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity; 21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average time 

per response 

(in hours) 

Total hours 

Preparation of DHCP letters; § 200.5 .................................. 6 1.3 8 100 800 

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

We have identified 24 DHCP letters 

that 18 distinct sponsors submitted to 

FDA during the 3-year period (2019 to 

2021). Based on our Document 

Archiving, Reporting, and Regulatory 

Tracking System, we estimate eight 

DHCP letters will be submitted annually 

from six application holders. Based on 

our experience, we assume that each 

letter will require 100 hours to prepare 

and disseminate as recommended in the 

guidance. Our estimate reflects a 

downward adjustment by five responses 

and 500 hours annually. We attribute 

this decrease to the effectiveness of the 

guidance and the decreased number of 

DHCP letters submitted for FDA review. 

Dated: June 16, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13536 Filed 6–23–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Proposed Temporary Changes in State 

Title V Maternal and Child Health Block 

Grant Allocations 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: This notice seeks comments 

on proposed temporary changes to the 

method of calculating poverty-based 

allocations under Title V of the Social 

Security Act for HRSA’s State Title V 

Maternal and Child Health (MCH) Block 

Grant. Since Fiscal Year (FY) 2017, the 

poverty-based allocation has been based 

on the U.S. Census Bureau’s 3-year 

American Community Survey (ACS) 

estimates using three pooled 1-year 

estimates. However, due to the COVID– 

19 pandemic, there were disruptions in 

the ACS data collection in 2020 

resulting in data quality issues that 

prevented the Census Bureau from 

releasing standard 1-year ACS estimates; 

instead, the Census Bureau released 

experimental estimates. HRSA proposes 

that the ACS 2020 experimental 

estimates be excluded from calculating 

MCH block grant allocations and that 

the FY 2023 funding allocation be based 

on the same poverty data used in the FY 

2022 allocation (i.e., pooled 1-year 

estimates for 2017, 2018, and 2019 

ACS). Funding allocations for FY 2024 

and FY 2025 would continue to 

incorporate the latest 1-year ACS data 

while skipping 2020 (i.e., for FY 2024, 

the 2018, 2019, and 2021 ACS data will 

be used; for FY 2025, the 2019, 2021, 

and 2022 ACS data will be used). In FY 

2026, the temporary change to the 

method for calculating allocations will 

no longer be necessary, and HRSA will 

resume pooling of three consecutive 1- 

year estimates (2021–2023). 

DATES: Interested persons are invited to 

comment on this proposed change. 

Submit written comments no later than 

July 25, 2022. All comments received on 

or before this date will be considered. 

ADDRESSES: All written comments 

concerning this notice should be 

submitted to Christopher Dykton, 

Acting Director of the Division of State 

and Community Health, at the contact 

information below. 

FOR FURTHER INFORMATION CONTACT: 

Christopher Dykton, Acting Director of 

the Division of State and Community 

Health, Maternal and Child Health 

Bureau (MCHB), HRSA, Room 18N35, 

5600 Fishers Lane, Rockville, Maryland 

20857; telephone: (301) 433–2204; 

email: MCHBlockGrant@hrsa.gov. 

SUPPLEMENTARY INFORMATION: The 

purpose of the Title V MCH Block 

Grant, administered by HRSA’s MCHB, 

is to improve the health of the nation’s 

mothers, infants, children, including 

children with special health care needs, 

and their families by creating federal/ 

state partnerships that provide each 

state/jurisdiction with needed flexibility 

to respond to its individual MCH 

population needs. Pursuant to section 

502(c) of Title V of the Social Security 

Act (42 U.S.C. 702(c)), for any available 

funding in excess of 1983 levels 

($406,649,394), Title V MCH Block 

Grant funds are allocated to States and 

the District of Columbia based on the 

number of children living in poverty in 

an individual state as a proportion of 

the total number of children living in 

poverty in the U.S., using data for the 

number of children in poverty in each 

State from the U.S. Census Bureau’s 

ACS. Incorporating the proportion of 

total number of children living in 

poverty into the state funding formula 

for the Title V MCH Block Grant ensures 

that a portion of the funding is 

distributed according to greatest need. 

Beginning in FY 2013, data for the 

number of children in poverty in each 

state has been based on the U.S. Census 

Bureau’s ACS.1 In FY 2013, the 

allocation was based on 3-year rolling 

ACS estimates instead of 1-year or 5- 

year ACS estimates also produced at 

that time to strike a balance between 

reliability and currency of data. See 77 

FR 65693 (October 30, 2012). However, 

since 2014 (for FY 2017), when the 

Census Bureau discontinued the release 

of 3-year ACS estimates, HRSA has been 

using three pooled ACS 1-year estimates 

for this purpose. 

In 2020, due to the COVID–19 

pandemic, there were disruptions in the 

ACS data collection that prevented the 

Census Bureau from releasing standard 

1-year ACS estimates for 2020. 

According to the Census Bureau report, 

‘‘An Assessment of the COVID–19 

Pandemic’s Impact on the 2020 ACS 1- 

Year Data,’’ 2 both survey administration 

methods (mailed questionnaires and 

interviewing in-person) were impacted 

beginning in March 2020. For example, 

no mailings were completed from April 

through June 2020, and when they 

resumed, they did not include the 

mailing of most of the reminder letters 

and postcards. Similarly, there was an 

abrupt switch from in-person to 

telephone-only interviews from March 

2020 through June 2020, and the 

universe of addresses for which 

telephone numbers can be obtained is 

likely different than the universe of 

addresses obtained through in-person 

methods, over-representing certain 

types of addresses. In May, the option 

to complete the interview online 

became available. In-person 


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